# What goes into the technical documentation, and how is it kept current?

## Introduction

A manufacturer that places a medical device, or an in vitro diagnostic medical device (IVD, a test run on samples taken from the body), on the European Union (EU) market draws up technical documentation. This file is the manufacturer's proof that the device meets the law, and it is kept up to date.

The file has two readers. Where the device's risk class requires a notified body, the independent organisation designated to certify devices, that body assesses the file. The national competent authorities, which police the market, can ask for it for at least 10 years after the last device is placed on the market. Under the Medical Device Regulation, Regulation (EU) 2017/745 (MDR), the period for implantable devices is at least 15 years.

The MDR and the In Vitro Diagnostic Medical Device Regulation, Regulation (EU) 2017/746 (IVDR), set what the file contains and how it links each legal requirement to the evidence that the device meets it. They also set what the label and the instructions for use carry, and which checks a planned change to the device has to pass before it is made.

Four running cases recur. Two are a wearable cardiac monitor from a US company and triage software enabled by artificial intelligence (AI) from a company in Germany. The others are a spinal implant system certified under Directive 93/42/EEC, the directive that preceded the MDR, and a near-patient cardiac troponin test from a Swiss company.

The MDR is stated as consolidated on 19 July 2026 and the IVDR on 10 January 2025. The sources were checked on 29 September 2026.

## In short

Every manufacturer must draw up technical documentation for its device and keep it up to date. The file has to let an assessor judge whether the device conforms with the regulation, and it contains the elements listed in Annexes II and III, the two annexes that set its contents. The MDR exempts custom-made devices, those made specifically for one patient; the IVDR sets the same duty with no such exemption. ([MDR Art. 10(4)][MDR]; [IVDR Art. 10(4)][IVDR])

The core of the file is a requirement-by-requirement trace. For each of the law's general safety and performance requirements that applies, Annex II Section 4 asks for the method used to show it is met, the standards or other solutions applied, and the precise identity and location of the documents giving the evidence. The file therefore has to point to specific documents and their place in the file, Team-NB, an association of notified bodies, adds in its guidance that a collection of test reports does not show how each requirement is met. ([MDR Annex II s. 4][MDR]; [IVDR Annex II s. 4][IVDR])

The file stays available for at least 10 years after the last device is placed on the market, or 15 for implantable devices under the MDR. It also has to keep pace with the product and with the rules. Changes in the device's design are taken into account in a timely manner. So are changes in the harmonised standards or common specifications against which conformity is declared. A harmonised standard is a European standard that, once its reference is published in the EU's Official Journal, lets the law presume conformity, and common specifications are technical requirements set by the Commission. Some changes go further. They need a new UDI device identifier (UDI-DI), the code that identifies a device model for traceability, or the notified body's approval before the change is made. Each planned change is therefore checked against these rules before it is made. ([MDR Art. 10(8), 10(9); Annex VI Part C s. 3.9; Annex IX s. 4.10][MDR]; [IVDR Art. 10(7), 10(8)][IVDR])

## 1. What is the technical documentation, and who reads it?

The notified body is one reader of the file. On the Annex IX route it audits the quality management system and assesses the technical documentation. Depending on the class, it assesses the files for a sample of devices or for every device (section 9). ([MDR Annex IX][MDR]; [IVDR Annex IX][IVDR])

National competent authorities are the other reader, and can ask for the file throughout the retention periods set out in section 2. A manufacturer outside the Union makes sure its authorised representative has the necessary documentation permanently available. ([MDR Art. 10(8)][MDR]; [IVDR Art. 10(7)][IVDR])

### What guidance is worth

The Medical Device Coordination Group (MDCG) is made up of members each Member State appoints to represent its competent authorities, and is chaired by a representative of the Commission. Each MDCG document cited here states that its views are not legally binding and that only the Court of Justice of the European Union can give binding interpretations of Union law. ([MDR Art. 103(2), (5)][MDR]; cover page of each MDCG document in Sources)

Team-NB, an association of notified bodies, publishes best-practice guidance on its members' interpretation, and each body may request more. The Commission's language tables say the regulations and national provisions take precedence over them. ([Team-NB MDR guidance V4, cover][TNB MDR]; [Team-NB IVDR guidance V2, cover][TNB IVDR]; [Commission MDR language table, Rev. 3][EC MDR languages])

Our reading, meaning our interpretation and not the text's own words, is that guidance shows how Member States, notified bodies or Commission services read the text.

## 2. How long is the file kept, and what keeps it current?

Manufacturers have procedures to keep series production in conformity. Changes in device design or characteristics are taken into account adequately and in a timely manner. So are changes in the harmonised standards or common specifications (CS) against which conformity is declared. ([MDR Art. 10(9)][MDR]; [IVDR Art. 10(8)][IVDR])

The EU declaration of conformity sits beside the file and is updated continuously. Annex IV lists its contents, including the risk class, where applicable the notified body and certificates, and the Basic UDI-DI, the primary identifier of a device model. A unique device identifier (UDI) combines a UDI device identifier (UDI-DI) with a production identifier, as section 7 explains. ([MDR Art. 19(1); Annex IV][MDR]; [IVDR Art. 17(1); Annex IV][IVDR])

| What is kept | MDR | IVDR |
|---|---|---|
| File, declaration and, if applicable, the relevant certificate | At least 10 years after the last device is placed on the market; at least 15 for implantable devices | At least 10 years |
| On the Annex IX route, change information and the notified body's decisions and reports | The same | The same |

([MDR Art. 10(8); Annex IX s. 7][MDR]; [IVDR Art. 10(7); Annex IX s. 6][IVDR])

## 3. What do Annexes II and III contain?

Annex II asks for the documentation to be presented in a clear, organised, readily searchable and unambiguous manner. IVDR Annex II has the same rule. Both have six numbered sections: device description and specification; information supplied by the manufacturer; design and manufacturing; the general safety and performance requirements (GSPR); benefit-risk analysis and risk management; and verification and validation. ([MDR Annex II][MDR]; [IVDR Annex II][IVDR])

**Figure 7.1. The six Annex II sections and the two Annex III items make one file, and three sections carry IVD-specific content.**

![Figure 7.1: the technical documentation map under MDR and IVDR Annexes II and III](figures/figure-7-1-technical-documentation-map.svg)



Sections 2, 4 and 5 read the same in both, apart from layout and small wording differences. The other three differ. ([IVDR Annex II s. 2, 4, 5][IVDR])

| Section | MDR asks for | IVDR differs by asking for |
|---|---|---|
| 1. Device description | Among other points, the intended purpose and users; the Basic UDI-DI; the qualification rationale; the class and rule; novel features; variants and accessories; raw materials; previous and similar devices | Intended purpose elements such as what is measured and the specimen type; the assay principle; reactive ingredients; software used with the device. No points on novel features, raw materials or technical specifications |
| 3. Design and manufacturing | The design stages; manufacturing processes and their validation; every design and manufacturing site, including suppliers and sub-contractors | Listed design elements, including the algorithm for software and design aspects suiting self-testing or near-patient testing. Manufacturing sites, including suppliers and sub-contractors; no design sites |
| 6. Verification and validation | Pre-clinical and clinical data, including biocompatibility, electrical safety, software verification and validation, and stability; the clinical evaluation plan and report; the post-market clinical follow-up (PMCF) plan and report, or a justification | Analytical performance, such as trueness and precision; the performance evaluation report; stability on at least three lots; software validation |

([MDR Annex II s. 1.1, 1.2, 3, 6.1][MDR]; [IVDR Annex II s. 1.1, 3.1, 3.2, 6][IVDR])

Further Section 6 points cover cases such as sterile devices and devices with a measuring function. Where no new testing was done, the MDR file gives a rationale, for example biocompatibility testing on identical materials in a previous version of the device legally placed on the market. Chapter 6 covers PMCF and its IVD counterpart. ([MDR Annex II s. 6.1(b), 6.2][MDR]; [IVDR Annex II s. 6.5][IVDR])

### Software evidence

The MDR asks for the software design and development process and for testing in a simulated or actual user environment. The IVDR asks for evidence of validation, without the development process. Both address all the hardware configurations and, where applicable, operating systems identified in the information supplied or the labelling. ([MDR Annex II s. 6.1(b)][MDR]; [IVDR Annex II s. 6.4][IVDR])

### Annex III: post-market surveillance

Annex III item 1 is the post-market surveillance plan, whose contents extend to the indicators and threshold values used when reassessing the benefit-risk analysis. It ends with a PMCF plan or, under the IVDR, a post-market performance follow-up plan. Item 2 is the periodic safety update report (PSUR) and the post-market surveillance report. ([MDR Annex III][MDR]; [IVDR Annex III][IVDR])

The PSUR applies to MDR classes IIa to III, where it forms part of the technical documentation except for custom-made devices, and to IVDR classes C and D. The post-market surveillance report applies to MDR class I and IVDR classes A and B. ([MDR Art. 85, 86(1)][MDR]; [IVDR Art. 80, 81(1)][IVDR])

MDCG 2025-10 says each device must be covered by a post-market surveillance plan, which may cover one device or a group of devices. Chapter 11 covers both reports. ([MDCG 2025-10, s. 4][MDCG 2025-10])

## 4. How does the file show that each requirement is met?

Annex I sets the GSPR. Annex II Section 4 asks the file to demonstrate conformity with those that apply, taking into account the intended purpose, with a justification, validation and verification of the solutions adopted. The IVDR asks for the same. ([MDR Annex II s. 4][MDR]; [IVDR Annex II s. 4][IVDR])

Under Section 4 the file lists the requirements that apply, explains why the others do not, and gives the method used for each. It names the harmonised standards, CS "or other solutions applied", and the precise identity of the controlled documents offering the evidence, cross-referenced to their place in the file. ([MDR Annex II s. 4][MDR])

The Annex prescribes no layout. Team-NB suggests a compliance matrix giving the edition or issue date of each standard, and lists as a common pitfall a requirement marked not applicable with no justification. ([Team-NB MDR guidance V4, s. 4][TNB MDR])

Our reading is that evidence named by title alone gives neither the precise identity nor the location Section 4 asks for.

Team-NB adds that a collection of test reports does not show how each requirement is met. It suggests linking verification and validation reports to the risk identifiers in the Annex II Section 5 risk management file. ([Team-NB MDR guidance V4, submission section][TNB MDR]; [MDR Annex II s. 5][MDR])

### What a harmonised standard adds

A harmonised standard is a European standard adopted on a Commission request for the application of Union harmonisation legislation. The definition does not mention publication of the reference, whereas the presumption of conformity depends on it. Devices that conform to relevant harmonised standards whose references have been published in the Official Journal of the European Union are presumed to conform to the requirements those standards cover. ([Reg. 1025/2012, Art. 2(1)][Reg 1025/2012]; [MDR Art. 8(1)][MDR]; [IVDR Art. 8(1)][IVDR])

Our reading is that where the file relies on a standard to show that a requirement is met, it names the edition whose reference is published. Where the file relies on anything else, it argues directly that the requirement is met. Chapter 5 sets out how a reference is checked.

## 5. What do the label and the instructions for use carry?

Under the MDR, Annex I Section 23 governs the label and the instructions for use. Each device comes with the information needed to identify it and its manufacturer, and any safety and performance information relevant to the user or any other person. A manufacturer with a website also makes that information available there and keeps it up to date. ([MDR Annex I s. 23.1][MDR])

Label information goes on the device, or on the packaging where that is not practicable or appropriate, in human-readable form. Residual risks to be communicated appear as limitations, contra-indications, precautions or warnings. Symbols and identification colours conform to the harmonised standards or CS, or are described in the documentation where none exist. ([MDR Annex I s. 23.1(b), (c), (g), (h)][MDR]; [IVDR Annex I s. 20.1(h)][IVDR])

### When can the instructions be left out?

Under the MDR, class I and class IIa devices that can be used safely without instructions need none, "unless otherwise provided for elsewhere in this Section". The IVDR names no class: in "duly justified and exceptional cases" instructions are not required, or may be abbreviated, if the device can be used safely and as intended without them. ([MDR Annex I s. 23.1(d)][MDR]; [IVDR Annex I s. 20.1(d)][IVDR])

### What each list covers

Figure 7.2 sets out the three MDR lists, and the table below adds the IVDR's label and instructions lists.

**Figure 7.2. The label, sterile packaging and instructions lists overlap, and none contains another.**

![Figure 7.2: what goes on the label, on the sterile packaging and in the instructions for use under MDR Annex I, Section 23](figures/figure-7-2-label-sterile-pack-instructions.svg)



| List | What it covers |
|---|---|
| Label, MDR | Among other points, the name; the manufacturer and, where it is outside the Union, its authorised representative; lot or serial number; the UDI carrier; use-by date; warnings; an indication that it is a medical device |
| Sterile packaging, MDR | Ten particulars, including the sterile state, the method of sterilisation, and an instruction to check the instructions for use if the packaging is damaged or unintentionally opened |
| Instructions for use, MDR | Some label particulars, plus, among other points, the intended purpose with indications, contra-indications and target groups; performance characteristics; residual risks; the date of issue; a notice to report serious incidents |
| Label, IVDR | An indication that the device is an in vitro diagnostic medical device; self-testing or near-patient testing where intended; for instructions not on paper, their accessibility |
| Instructions for use, IVDR | Adds the test principle and the assay procedure, and asks for analytical and clinical performance characteristics |

([MDR Annex I s. 23.2 to 23.4][MDR]; [IVDR Annex I s. 20.2, 20.4.1][IVDR])

Where applicable, the instructions link to the summary of safety and clinical performance (SSCP), which Article 32 requires for implantable and class III devices, other than custom-made or investigational devices. MDCG 2019-9 rev.1 says the instructions should give the Basic UDI-DI or other data to find it in EUDAMED, the European database on medical devices. ([MDR Annex I s. 23.4(d); Art. 32(1)][MDR]; [MDCG 2019-9 rev.1, general requirements][MDCG 2019-9])

For devices incorporating electronic programmable systems, including software, or software that is a device in itself, the instructions give minimum requirements for hardware, information technology (IT) network characteristics and IT security measures. ([MDR Annex I s. 23.4(ab)][MDR])

### In which language?

The Section 23 information comes in the official Union language or languages determined by the Member State where the device is made available to the user or patient. The IVDR rule is the same, and adds that information for self-testing and near-patient devices is easily understandable. The file holds the labels and instructions in the languages accepted where the device is envisaged to be sold. ([MDR Art. 10(11); Annex II s. 2][MDR]; [IVDR Art. 10(10)][IVDR])

As a dated example, the Commission's MDR table, Rev. 3 of August 2025, says Member States are not obliged to determine a specific language. It encourages them to consider accepting another, such as English, where safe use is not compromised, especially for devices for professional use. The latest revision of the table gives each country's entry. ([Commission MDR language table, Rev. 3][EC MDR languages])

### When can the instructions be electronic?

Under the MDR, instructions may be in non-paper form only under the implementing rules, now Implementing Regulation (EU) 2021/2226 as amended by Regulation 2025/1234. That regulation repealed Regulation (EU) No 207/2012, which still applied to Article 120(3) devices until 26 May 2024. ([MDR Annex I s. 23.1(f)][MDR]; [Reg. 2021/2226, Art. 1, 10][REG 2021/2226]; [Reg. 2025/1234, Art. 1][REG 2025/1234])

Manufacturers may provide electronic instructions instead of paper for MDR Article 1(4) devices intended for professional users. Article 1(4) covers medical devices, their accessories and Annex XVI products, so on our reading the route reaches all three. Where lay use is reasonably foreseeable, lay instructions are on paper. Software covered by the MDR may carry its own electronic instructions. ([Reg. 2021/2226, Art. 3][REG 2021/2226]; [MDR Art. 1(4)][MDR])

| Condition | What applies |
|---|---|
| Risk assessment | Documented, covering at least eleven listed elements, including emergencies needing paper; updated with post-market experience |
| Safety | The assessment shows that electronic provision maintains or improves the level of safety of paper |
| Paper on request | At no extra cost, within the period the risk assessment sets and at the latest within 7 calendar days, or at delivery if requested with the order |
| Label | States that the instructions are electronic, with access information including the Basic UDI-DI or the UDI-DI |
| Website | Conditions on format, tampering, downtime and data protection; a stable address |
| Availability, devices with an expiry date, other than implantables | 10 years after the last device is placed on the market, and at least 2 years after the end of the expiry date of the last produced device |
| Availability, other devices | 15 years after the last device is placed on the market |

([Reg. 2021/2226, Art. 4 to 7][REG 2021/2226])

Our reading is that, for a device with an expiry date, both periods in that row of the table apply, so whichever ends later governs. Team-NB says the risk assessment can sit in the risk management section of the file. ([Team-NB MDR guidance V4, s. 2.4][TNB MDR])

The IVDR has its own rule: where a device is intended for professional use only, the instructions may be in non-paper form, except for near-patient testing. ([IVDR Annex I s. 20.1(f)][IVDR])

## 6. Which edition of a labelling standard can the file cite?

The Union lists of harmonised standards give each standard by its European reference, which starts with EN. Each list is an Implementing Decision, and its latest consolidation on EUR-Lex is the current list. ([Dec. 2021/1182, Annex][DEC 2021/1182]; [Dec. 2021/1195, Annex][DEC 2021/1195])

Three ISO labelling standards, as dated examples:

| Standard | Position on the check date |
|---|---|
| EN ISO 15223-1:2021, symbols | Entry 12 in the MDR list and 8 in the IVDR list. In June 2026 each list added an entry, 12a in the MDR list and 8a in the IVDR list, for the standard as amended in 2025. Each list deletes the old entry from 17 June 2031; for the MDR list, a corrigendum set that date |
| ISO 20417, information supplied by the manufacturer | No entry in either list in the consolidations of 17 June 2026. The March 2026 edition replaces the 2021 edition, which is withdrawn |
| EN ISO 18113-1:2024 to EN ISO 18113-5:2024, IVD labelling | Entries 19 to 23 in the IVDR list, in force from 30 January 2026 |

([Dec. 2021/1182, Annex][DEC 2021/1182]; [Dec. 2021/1195, Annex][DEC 2021/1195]; [Dec. 2026/1231, Annex, Art. 2][DEC 2026/1231]; [corrigendum][DEC 2026/1231 corr]; [Dec. 2026/1313, Art. 2][DEC 2026/1313]; [Dec. 2026/197, Art. 1, 2][DEC 2026/197]; [ISO 20417:2026][ISO 20417:2026]; [ISO 20417:2021][ISO 20417:2021])

The amendment's catalogue title describes a "modified EC REP symbol to not be country or region specific", EC REP being the authorised representative's symbol. ([ISO 15223-1:2021/Amd 1:2025][ISO 15223-1 Amd 1])

Our reading is that a file citing either edition of ISO 20417 gains no presumption of conformity from it on the check date, so the file has to show directly that the device meets Annex I Section 23. A file citing EN ISO 15223-1:2021 can keep citing it until the lists delete that entry. ([MDR Art. 8(1)][MDR])

## 7. How does the Basic UDI-DI tie the file together?

The UDI system lets a device be identified and traced. A UDI is made of a UDI-DI, specific to a model of device, and a UDI production identifier (UDI-PI), which identifies the unit of device production. The Basic UDI-DI is the main key for records in the UDI database and is referenced in certificates and EU declarations of conformity. ([MDR Art. 27(1); Annex VI Part C s. 1][MDR])

| Where the Basic UDI-DI appears | Rule |
|---|---|
| Device description | Annex II Section 1.1(b) asks for it once identification is based on a UDI system |
| Declaration of conformity | Article 27(6) and Annex IV |
| Certificate, MDR | Class III devices, class IIb implantables assessed device by device, and class IIb devices on the Annex X and XI route, under Article 52(3) and (4) |
| Certificate, IVDR | Class D on either route, class B and C for self-testing or near-patient testing under Annex IX Section 5.1, and class C on the Annex X and XI route, under Article 26(2) |

([MDR Art. 27(6), 29(3), 52(3), 52(4); Annex II s. 1.1(b); Annex IV][MDR]; [IVDR Art. 26(2), 48(8)][IVDR])

On the routes where the certificate carries the Basic UDI-DI, the manufacturer assigns it before applying to the notified body, which references it on the certificate. The technical documentation holds an up-to-date list of all the UDIs assigned, a list that MDCG 2021-19 interprets as covering both UDI-DIs and UDI-PIs. ([MDR Art. 27(7), 29(3)][MDR]; [IVDR Art. 24(7), 26(2)][IVDR]; [MDCG 2021-19, product documentation][MDCG 2021-19])

MDCG 2018-1 rev.4 says the Basic UDI-DI connects devices with the same intended purpose, risk class and essential design and manufacturing characteristics, although the definition in Annex VI does not set out this test. MDCG 2022-7 leaves the grouping to the manufacturer and recommends aligning it with the notified body where the device needs a product certificate. ([MDCG 2018-1 rev.4, the Basic UDI-DI][MDCG 2018-1]; [MDCG 2022-7, s. B, q. 1][MDCG 2022-7])

One such product certificate is the EU technical documentation assessment certificate, issued when a file is assessed and found to conform under Annex IX Section 4, or IVDR Annex IX Section 5.1 or 5.2. Annex IX Section 4 covers MDR class III, MDR class IIb implantables not on the Article 52(4) lists, and IVDR class D. MDCG 2019-13 rev.1 says devices assessed only by sample receive none. ([MDR Annex IX s. 4, 4.9][MDR]; [IVDR Art. 48(3); Annex IX s. 4.10, 5.1(e), 5.2(e)][IVDR]; [MDCG 2019-13 rev.1, s. 5.2][MDCG 2019-13])

The MDR puts the assignment of the Basic UDI-DI on the manufacturer. MDCG 2026-5 adds that the manufacturer is the only entity that can assign UDIs to a device for the EU market. A third party may deal with the issuing entities on its behalf, while the legal liability stays with the manufacturer. ([MDR Art. 29(1)][MDR]; [MDCG 2026-5, conclusions][MDCG 2026-5])

MDCG 2022-7 says a distributor selling under its own name takes on the manufacturer's UDI duties and assigns a new Basic UDI-DI. Where it agrees that the manufacturer stays named on the label and responsible, the device keeps the manufacturer's Basic UDI-DI. Chapter 9 covers assignment and EUDAMED registration. ([MDCG 2022-7, s. B, q. 2][MDCG 2022-7])

## 8. What does a change to the device mean for the file?

### When does a change need a new identifier?

Annex VI requires a new UDI-DI whenever a change could lead to misidentification of the device or ambiguity in its traceability. In particular, a change to any of seven data elements needs one. They are name or trade name; version or model; labelled as single use; packaged sterile; need for sterilisation before use; quantity in a package; and critical warnings or contra-indications. The IVDR lists the same seven. ([MDR Annex VI Part C s. 3.9][MDR]; [IVDR Annex VI Part C s. 3.9][IVDR])

MDCG 2018-1 rev.4 adds, as changes needing a new UDI-DI, a change concerning substances that are carcinogenic, mutagenic or toxic to reproduction, or endocrine-disrupting, and a change of colour or language where it could cause misidentification. ([MDR Annex I s. 10.4.1(a)][MDR]; [MDCG 2018-1 rev.4, changes of UDI-DI][MDCG 2018-1])

For software, a new UDI-DI is needed whenever a modification changes the original performance, the safety or intended use, or the interpretation of data. A new or modified algorithm is one such modification. Minor revisions need a new UDI-PI only, and the Annex associates them generally with bug fixes, security patches, usability enhancements not made for safety, and operating efficiency. The IVDR sets the same test. ([MDR Annex VI Part C s. 6.5.2, 6.5.3][MDR]; [IVDR Annex VI Part C s. 6.2.2][IVDR])

MDCG 2018-5 asks manufacturers to check whether a change to software's function affects its qualification, class, intended purpose or essential design, since that could trigger a new Basic UDI-DI. ([MDCG 2018-5, evaluation of changes][MDCG 2018-5])

### When does the notified body approve a change first?

| Change | What applies |
|---|---|
| A substantial change to an approved quality management system, or to the device range it covers | The manufacturer informs the body of the plan, and the body approves it by a supplement to the quality management system certificate |
| A change that could affect safety and performance, or the conditions prescribed for use, of a device with an EU technical documentation assessment certificate | The body that issued the certificate approves it, by a new conformity assessment or a supplement to the certificate. IVDR Section 5.1(f) sets the same rule for self-testing and near-patient devices |
| A change affecting a companion diagnostic's performance, intended use or suitability for the medicinal product | The manufacturer informs the body first, and before issuing a supplement to the certificate the body seeks the opinion of the medicinal products authority it consulted in the original assessment |

([MDR Annex IX s. 2.4, 4.10][MDR]; [IVDR Annex IX s. 2.4, 4.11, 5.1(f), 5.2(f)][IVDR])

The notified body has documented procedures and contract terms for changes, including measures for checking how significant a change is. Under the MDR they cover changes to the approved design and to the intended use of, or claims made for, the device. The body ensures that plans for such changes are submitted for prior approval. The IVDR list has no item on intended use or claims. ([MDR Annex VII s. 4.9][MDR]; [IVDR Annex VII s. 4.9][IVDR])

Implementing Regulation (EU) 2026/977 sets maximum periods for the body's work on these changes, which chapter 8 covers. For re-certification of a product certificate, the body asks for a list of the changes, notified or not, since the initial certification or the last re-certification. Our reading is that a dated record of the planned changes, showing how each was handled, can serve as that list. ([Reg. 2026/977, Art. 2(3), 5(1)(a)][REG 2026/977])

As a dated example, the regulation applies from 25 February 2027. Its maximum periods do not apply to procedures under a written agreement with the notified body signed before that date. Its re-certification rules do not apply to certificates expiring before 25 November 2027. Articles 8 and 9 of the regulation set these dates. ([Reg. 2026/977, Art. 8, 9][REG 2026/977])

### What changes for a device still under the directives?

A legacy device is one that Article 120 lets be placed on the market after 26 May 2021 under a directive certificate or declaration. Paragraph 3a covers devices with a directive certificate, and paragraph 3b devices declared without a notified body that now need one. MDCG 2021-25 rev.1 treats devices placed on the market before that date separately. ([MDR Art. 120(3), (3a), (3b)][MDR]; [MDCG 2021-25 rev.1, title][MDCG 2021-25])

A legacy device may be placed on the market only if, among other conditions, there are no significant changes in design and intended purpose. The IVDR sets the same condition, and the latest consolidations of MDR Article 120 and IVDR Article 110 give the dates until which legacy devices may be placed on the market. ([MDR Art. 120(3c)][MDR]; [IVDR Art. 110(3c)][IVDR])

MDCG 2020-3 rev.1 says a significant change needs two cumulative elements: a change in design or intended purpose, and the significance of that change. The manufacturer documents the outcome for a competent authority to request. Changes to the manufacturer's organisation or manufacturing process should generally not be treated as design changes, even when the label must change. ([MDCG 2020-3 rev.1, s. 4.1, 4.2][MDCG 2020-3])

Where the device holds a notified body certificate, the same guidance says the body verifies changes under the notification arrangements agreed under the directive. MDCG 2022-6 gives the IVD counterpart. ([MDCG 2020-3 rev.1, s. 4.1, 4.2][MDCG 2020-3]; [MDCG 2022-6, s. 4.1][MDCG 2022-6])

A legacy device keeps complying with the directive, and Article 120(3d) applies the MDR's requirements on post-market surveillance, market surveillance, vigilance and registration in place of the directive's. MDCG 2021-25 rev.1 says other MDR requirements should in principle not apply. Its examples include Articles 18, 19, 27 and 32: the implant card, the declaration, UDI and the SSCP. MDCG 2022-8 says the same under the IVDR. ([MDR Art. 120(3c)(a), 120(3d)][MDR]; [MDCG 2021-25 rev.1, s. 3.1][MDCG 2021-25]; [MDCG 2022-8, s. 2][MDCG 2022-8])

Our reading is that a company seeking its first MDR certificate for a legacy device runs two sets of paperwork for a time. One is the directive file for the device on the market, and the other is the MDR file under assessment. Figure 7.3 therefore first asks whether the device is a legacy device.

**Figure 7.3. A planned change passes three checks, and each can add documents to the file.**

![Figure 7.3: routing a planned change through the transition, identifier and notified body checks](figures/figure-7-3-routing-a-planned-change.svg)



## 9. How does the notified body sample the files?

| Class | How the notified body assesses the file |
|---|---|
| MDR IIa, IVDR B | At least one representative device per category of devices |
| MDR IIb, IVDR C | At least one representative device per generic device group |
| MDR IIb implantables, except the types on the Article 52(4) lists | Device by device |
| IVDR C companion diagnostics | Device by device |
| IVDR B and C for self-testing or near-patient testing | The sampled assessment, plus the assessment in Annex IX Section 5.1 |

([MDR Art. 52(4), 52(6)][MDR]; [IVDR Art. 48(7), 48(9)][IVDR])

The body chooses the sample on a representative basis, weighing criteria such as novelty, and documents why. During surveillance, the body assesses further samples. ([MDR Annex IX s. 2.3, 3.5][MDR]; [IVDR Annex IX s. 2.3, 3.5][IVDR])

In MDCG 2019-13 rev.1's own definitions, a category of devices follows the device codes of Regulation (EU) 2017/2185, and a generic device group the European Nomenclature on Medical Devices. A "device" means all the devices under one Basic UDI-DI. ([MDCG 2019-13 rev.1, s. 3][MDCG 2019-13])

Under the guidance, a file chosen for the sample is assessed in the same depth as a class III file, including its variants. Our reading is that every file in a group has to be ready for assessment, since the body chooses which one to read. ([MDCG 2019-13 rev.1, s. 5.1][MDCG 2019-13])

The guidance expects at least one file reviewed each year, and 15% of devices in each category or group over a certificate's validity. A footnote allows 5% until a wider revision of the guidance. The Commission's endorsed-documents page listed no later revision on 27 September 2026. The body should review its sampling plan when the product range changes. ([MDCG 2019-13 rev.1, s. 4.1.2, 6][MDCG 2019-13]; [MDCG endorsed documents page][MDCG endorsed])

Delegated Regulation (EU) 2026/1359 replaced the Article 52(4) lists of sampled implantable types, which include screws, plates, pins, dental implants and spinal posterior fixations. On our computation, meaning a date we worked out that the text does not print, it came into force on 19 July 2026, twenty days after its publication on 29 June 2026. The list in the guidance's footnote is shorter, so where the two differ, the Article in the latest MDR consolidation governs. ([MDR Art. 52(4)][MDR]; [Del. Reg. 2026/1359, Art. 1, 2][DR 2026/1359]; [MDCG 2019-13 rev.1, s. 5.3][MDCG 2019-13])

The guidance also exempts IVDR class B and C devices for self-testing, near-patient testing and companion diagnostics from sampling. For self-testing and near-patient devices, Article 48(7) and (9) require the Section 5.1 assessment "In addition to" the sampled assessment. Our reading is that the exemption is the guidance's own account of how the two assessments combine, which the Article does not state. ([MDCG 2019-13 rev.1, s. 5.3][MDCG 2019-13]; [IVDR Art. 48(7), (9)][IVDR])

## 10. What does an AI system in the device add?

The AI Act, Regulation (EU) 2024/1689, requires up-to-date technical documentation for a high-risk AI system. A system is high-risk under Article 6(1) where it is, or is a safety component of, a product needing third-party conformity assessment under the Annex I legislation. Annex I Section A lists the MDR and the IVDR, and for such products a single set of technical documentation holds what both the AI Act and that legislation require. ([AI Act, Art. 6(1), 11(1), 11(2); Annex I s. A][AI Act])

For those systems, Article 11 applies from the date in Article 113, point (c)(ii). As a dated example, that is 2 August 2028 in the consolidation of 27 July 2026; the latest consolidation gives the current date. AI Act Annex IV sets the minimum content, including the version of the system and its relation to previous versions. Chapter 10 covers the rest, including a simplified form, once the Commission establishes it, for small and medium-sized enterprises, start-ups and small mid-cap companies. ([AI Act, Art. 11(1), 113; Annex IV point 1][AI Act])

## 11. What would the Commission's proposal change?

On 16 December 2025 the Commission proposed amending the MDR and the IVDR, as procedure 2025/0404(COD). It would let a manufacturer draw up and make available the file in a digital format, to be agreed with the notified body where the body assesses the file. It would also amend Annex II Section 6 in both regulations. ([COM(2025) 1023 final, title page, proposed Art. 52b][COM 2025/1023]; [annexes][COM annexes])

None of these proposed changes alters the manufacturer's duties until the proposal is adopted and applies. As a dated example, on 29 September 2026 the European Parliament's Legislative Observatory, which records its progress, showed it as "Awaiting committee decision". ([Legislative Observatory, 2025/0404(COD)][OEIL])

## 12. How the answer is reached

The answers depend on one another in this order:

1. **The device's class, its conformity assessment route and the company's role come first**, as chapter 1 sets them. ([MDR Art. 10(4)][MDR])
2. **The file follows the Annex II and III headings.** ([MDR Annex II][MDR])
3. **The device description is built around the Basic UDI-DI**, assigned before applying to the notified body on the certificate routes. ([MDR Art. 29(3)][MDR]; [IVDR Art. 26(2)][IVDR]; [MDCG 2022-7, s. B, q. 1][MDCG 2022-7])
4. **Each requirement in Annex I is traced** to its method, its standard and edition, and its evidence. The trace is linked to the risk file. ([MDR Annex II s. 4, 5][MDR]; [Team-NB MDR guidance V4, s. 4][TNB MDR])
5. **Each cited edition is checked against the Union list**, since the file has to take changes in the standards into account. ([MDR Art. 10(9)][MDR])
6. **The label, sterile packaging and instructions follow their own lists**, in each accepted language, and electronic instructions come with the documents that Articles 4 and 5 of the electronic instructions regulation require. ([MDR Annex II s. 2][MDR]; [Reg. 2021/2226, Art. 4, 5][REG 2021/2226])
7. **The UDI list and the declaration stay current.** ([MDR Art. 19(1), 27(7)][MDR])
8. **Each planned change passes the checks in figure 7.3 before it is made.** ([MDR Annex VII s. 4.9][MDR])
9. **The retention period depends on the device**, both for the file and for any electronic instructions. ([MDR Art. 10(8)][MDR]; [Reg. 2021/2226, Art. 5][REG 2021/2226])

## 13. The four running cases

Anything not drawn from chapter 1 is an illustrative assumption.

### The monitor: a wearable cardiac monitor from a US company

Chapter 1 classes the hardware IIa under Rule 10 on its reading. It classes the application on the patient's phone separately: IIa if it only records for later review, IIb if it analyses the rhythm to guide a physician's diagnosis. The planning assumption is that it only records, and Germany and the Netherlands are the illustrative first markets.

| Question | Answer | Basis |
|---|---|---|
| Sample | At least one representative device per category of devices | [MDR Art. 52(6)][MDR] |
| Instructions | Needed, on our reading: a lay wearer who fits the sensor and pairs the application cannot use it safely without them | [MDR Annex I s. 23.1(d)][MDR] |
| Electronic instructions | Paper for the monitor on our reading, since a lay patient wears it. The application may carry its own electronic instructions, with the Article 4 risk assessment and the minimum IT requirements | [Reg. 2021/2226, Art. 3, 4][REG 2021/2226]; [MDR Annex I s. 23.4(ab)][MDR] |
| A new phone operating system | A change to the file on our reading, since the software evidence has to cover each operating system the instructions name | [MDR Annex II s. 6.1(b)][MDR] |
| A new algorithm in the application | A new UDI-DI on our reading, because it changes the original performance. An algorithm that analyses the rhythm also moves the application to IIb, where the body samples per generic device group, and MDCG 2018-5 then asks the manufacturer to check whether a new Basic UDI-DI follows. A bug fix that changes none of performance, safety, intended use and the interpretation of data needs a new UDI-PI only | [MDR Art. 52(4); Annex VI Part C s. 6.5.2, 6.5.3][MDR]; [MDCG 2018-5][MDCG 2018-5] |
| Documentation in the Union | Permanently available to the authorised representative, with labels and instructions in each language Germany and the Netherlands accept | [MDR Art. 10(8), 10(11); Annex II s. 2][MDR] |

### The triage tool: AI-enabled software from a company in Germany, planned as class IIb

Chapter 1 finds classes IIa to III all arguable under Rule 11 and takes class IIb as the planning assumption.

**Assumptions (illustrative).** The company takes the Annex IX route, the first of the two routes that chapter 1 leaves open. The tool is first placed on the market under the MDR. Release 2.1 retrains the algorithm.

| Question | Answer | Basis |
|---|---|---|
| Sample | At least one representative device per generic device group; on MDCG 2019-13 rev.1's reading, a device assessed only by sample receives no EU technical documentation assessment certificate | [MDR Art. 52(4)][MDR]; [MDCG 2019-13 rev.1, s. 5.2][MDCG 2019-13] |
| Release 2.1, check 1 | The legacy device check does not apply, since the tool is not a legacy device | Assumption above |
| Release 2.1, check 2 | A new UDI-DI on our reading, since a retrained algorithm changes the original performance; MDCG 2018-5 then asks about a new Basic UDI-DI | [MDR Annex VI Part C s. 6.5.2][MDR]; [MDCG 2018-5][MDCG 2018-5] |
| Release 2.1, check 3 | On our reading, the plan for the change goes to the notified body for prior approval before release, and the body's procedures check how significant the change is. The approval rule for devices holding a certificate does not apply, since the tool holds none. A substantial change to the device range covered by the quality management system would also go to the body as a plan | [MDR Annex VII s. 4.9; Annex IX s. 2.4][MDR] |
| Electronic instructions | Available as an option, since triage nurses are professional users; the risk assessment covers an internet outage in the urgent care centre | [Reg. 2021/2226, Art. 3, 4(1)(h)][REG 2021/2226] |

Our reading on check 3, the notified body check, is that the tool, assessed only by sample, has no approved design because it holds no certificate. The item in Annex VII that applies is therefore a change to its intended use or to the claims made for it. The instructions state its performance characteristics, so a release that changes the original performance changes a claim. ([MDR Annex I s. 23.4(e); Annex VII s. 4.9][MDR])

The tool is a high-risk AI system through Annex I of the AI Act, as chapter 10 sets out. Its AI Act and MDR documentation therefore form a single set from the date chapter 10 gives. Our reading is that a retrained release such as 2.1 is a new version for Annex IV. ([AI Act, Art. 11(2), 113; Annex IV point 1][AI Act])

### The implant: a spinal implant system from a European company with a directive certificate

Chapter 1 classes the interbody cage III, the screws and plates IIb, and hooks IIb on MDCG 2021-24 rev.1's reading, leaving rods, wires and pins open. Its illustrative assumptions are a certificate under Directive 93/42/EEC and a company seeking its first MDR certificate.

**Assumptions (illustrative).** The directive certificate qualifies under Article 120, and the company met each Article 120(3c) deadline. The interbody cage is supplied sterile. The company plans a new supplier for the same material, to unchanged specifications.

| Question | Answer | Basis |
|---|---|---|
| Device on the market | The device already on the market keeps complying with the directive, while following the MDR's surveillance, vigilance and registration rules. On our reading the rows below apply to the MDR file under assessment | [MDR Art. 120(3c)(a), 120(3d)][MDR] |
| Assessment of the MDR file | Annex IX Section 4, with the cage's Basic UDI-DI assigned before applying | [MDR Annex IX s. 4; Art. 29(3), 52(3)][MDR] |
| Screws, plates and spinal posterior fixations | Sampled, so on our reading each of their files has to be ready for assessment | [MDR Art. 52(4)][MDR]; [MDCG 2019-13 rev.1, s. 5.1][MDCG 2019-13] |
| Sterile cage | Ten particulars on the sterile packaging, and sterilisation validation reports under Annex II Section 6.2(e) | [MDR Annex I s. 23.3; Annex II s. 6.2(e)][MDR] |
| SSCP and implant card | Both are needed for the MDR version: the class III cage is within Article 32 and outside the Article 18(3) exemptions. On MDCG 2021-25 rev.1, neither should in principle apply to the legacy device, though national implant card rules may | [MDR Art. 18, 32(1)][MDR]; [MDCG 2021-25 rev.1, s. 3.1][MDCG 2021-25] |
| Supplier change, check 1 | Notified to the body under the procedure agreed under the directive. MDCG 2020-3 rev.1 says it should generally not count as a design change; the documented outcome is kept for the competent authority | [MDCG 2020-3 rev.1, s. 4.1, 4.2][MDCG 2020-3] |
| Supplier change, checks 2 and 3 | These checks apply to the MDR version only, since MDCG 2021-25 rev.1 says legacy devices are not subject to the MDR UDI requirements. No new UDI-DI is needed on our reading, since the change creates no risk of misidentification and changes none of the listed data elements | [MDR Annex VI Part C s. 3.9][MDR]; [MDCG 2021-25 rev.1, s. 3.2][MDCG 2021-25] |
| Retention | At least 15 years after the last implant is placed on the market | [MDR Art. 10(8)][MDR] |

### The near-patient test: a cardiac troponin test from a Swiss company, planned as class C

Chapter 1 gives the test two intended purposes, serial measurement at class C and single measurement at class B on the guidance's contested reading, and plans both as class C. The rows use the serial purpose; at class B the sample would be per category of devices. Chapter 1 assumes, for illustration, distributors in Germany, the Netherlands, Belgium and Austria, and a legacy declaration under Directive 98/79/EC. ([IVDR Art. 48(7), (9)][IVDR])

**Assumption (illustrative).** Of the two routes chapter 1 leaves open, Annex IX with Section 5.1 or Annex X with Annex XI except its Section 5, the company takes Annex IX.

| Question | Answer | Basis |
|---|---|---|
| Test on the market | Keeps complying with Directive 98/79/EC, with no significant change in design or intended purpose. MDCG 2022-8 says IVDR requirements beyond surveillance, vigilance and registration, UDI among them, should in principle not apply. On our reading the rows below are for the IVDR file | [IVDR Art. 110(3c)][IVDR]; [MDCG 2022-8, s. 2][MDCG 2022-8] |
| Device description | Intended purpose elements such as the specimen type and the intended user, and the design aspects that suit near-patient testing | [IVDR Annex II s. 1.1(c), 3.1][IVDR] |
| Sample | At least one representative device per generic device group, plus the Section 5.1 assessment; on MDCG 2019-13 rev.1's reading, there is no sampling and every device covered receives a Section 5.1 certificate | [IVDR Art. 48(7)][IVDR]; [MDCG 2019-13 rev.1, s. 5.3][MDCG 2019-13] |
| Section 5.1 application | Test reports, including studies with intended users; where practicable, an example of the device; data showing the test suits near-patient testing; the label and instructions | [IVDR Annex IX s. 5.1(b)][IVDR] |
| Certificate | An EU technical documentation assessment certificate if the test conforms; changes that could affect safety and performance then need the body's approval | [IVDR Annex IX s. 5.1(e), (f)][IVDR] |
| Basic UDI-DI | Assigned before applying to the notified body, since Article 26(2) applies that rule to the assessment in the second subparagraph of Article 48(7) | [IVDR Art. 26(2)][IVDR] |
| Instructions | On paper, with no single-copy allowance, since both the electronic instructions rule and that allowance exclude near-patient testing | [IVDR Annex I s. 20.1(e), (f)][IVDR] |
| Label | Indicates near-patient testing, with the information easily understandable in each Member State's language | [IVDR Annex I s. 20.2(q); Art. 10(10)][IVDR] |
| Labelling standards | On our reading, parts 1 and 2 of EN ISO 18113:2024, on general requirements and reagents for professional use; part 3, on instruments, belongs in the file of the point-of-care analyser the company supplies | [Dec. 2021/1195, Annex][DEC 2021/1195] |
| Documentation in the Union | Permanently available to the authorised representative, and kept for at least 10 years after the last test is placed on the market | [IVDR Art. 10(7)][IVDR] |

## 14. When specialist help is worth paying for

- **The device contains a medicinal substance, tissues or cells, or substances absorbed by the body.** Each adds evidence to the file. ([MDR Annex II s. 6.2][MDR])
- **A legacy device needs a change.** Whether it is significant decides whether the device stays in the transition. ([MDR Art. 120(3c)][MDR]; [MDCG 2020-3 rev.1, s. 4.1][MDCG 2020-3])
- **A companion diagnostic changes.** The notified body consults the medicinal products authority on some changes. ([IVDR Annex IX s. 5.2(f)][IVDR])
- **Lay people may use a professional device with electronic instructions.** Their instructions go on paper. ([Reg. 2021/2226, Art. 3, 5][REG 2021/2226])
- **A partner sells under its own name or handles the UDIs.** ([MDCG 2026-5, conclusions][MDCG 2026-5]; [MDCG 2022-7, s. B, q. 2][MDCG 2022-7])
- **The first technical conversation with a notified body is near.** Team-NB advises agreeing the folder structure before submission. ([Team-NB MDR guidance V4, submission section][TNB MDR])

## Conclusion

How many of a company's files a notified body, the independent organisation that certifies the device, reads depends on the device's risk class, its certification procedure (the conformity assessment route), and the company's role, as chapter 1 sets them. Depending on these, the body assesses the files for a sample of devices or for every device. On our reading, every file in a sampled group has to be ready for assessment, since the body chooses which one to read.

Annexes II and III give the file its sections. The central piece is the trace in Annex II Section 4, which links each applicable general safety and performance requirement, the law's basic list of what a device must achieve, to its evidence.

The Basic UDI-DI, the main identifier of a device model in the EU's device database, appears in the device description, in the declaration of conformity (the manufacturer's statement of conformity), and, on some routes, in the notified body's certificate. It links those documents, and where the certificate carries it, the company assigns it before applying. A change to the device can require any of these documents to be revised. Some need a new model identifier (UDI-DI) or the body's prior approval.

For the wearable heart monitor from a US company, on our reading the instructions must be on paper because a lay patient wears it. On the same reading, a new algorithm in its phone application needs a new UDI-DI. If that algorithm analyses the heart rhythm, it also makes the application class IIb, which changes how the body samples files. For the AI triage software from a company in Germany, planned as class IIb, on our reading the release that retrains its algorithm needs a new UDI-DI. On the same reading, the plan for that release goes to the body for approval before the release ships, because a change in performance changes a claim stated in its instructions.

The spinal implant system, certified under the earlier Medical Devices Directive, runs two sets of paperwork until it receives its first certificate under the Medical Device Regulation (MDR): the directive file for the product on the market and the MDR file under assessment. Its planned supplier change is notified to the body under the procedure agreed under the directive and, on our reading, needs no new UDI-DI for the MDR version. The near-patient cardiac troponin test from a Swiss company stays on the market under the earlier IVD directive while the conditions of Article 110 of the IVD Regulation (IVDR) hold, among them that its design and intended purpose do not change significantly. Its IVDR file carries paper instructions, because the IVDR allows electronic instructions for professional-use tests except those used near the patient. The file also carries a Basic UDI-DI assigned before the company applies for the Section 5.1 assessment, the extra notified body review for near-patient tests.

Chapters 5 and 6 cover the standards and evidence the file cites, chapters 8 and 9 the notified body and registration, and chapters 10 and 11 the AI Act and the post-market reports.

## Sources

Each statement was checked against the version shown on the date in the last column.

| Source | Version used | Date of that version | Link | Checked |
|---|---|---|---|---|
| Regulation (EU) 2017/745 on medical devices (MDR), consolidated text | CELEX 02017R0745-20260719, consolidation 007.001, last amendment Delegated Regulation (EU) 2026/1451 | 19 July 2026 | [Publications Office][MDR] | 29 September 2026 |
| Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR), consolidated text | CELEX 02017R0746-20250110, consolidation 005.001, last amendment Regulation (EU) 2024/1860 | 10 January 2025 | [Publications Office][IVDR] | 29 September 2026 |
| Implementing Regulation (EU) 2021/2226 on electronic instructions for use, consolidated text | CELEX 02021R2226-20250716, consolidation 001.001, M1 Implementing Regulation (EU) 2025/1234 | 16 July 2025 | [Publications Office][REG 2021/2226] | 29 September 2026 |
| Implementing Regulation (EU) 2025/1234 amending 2021/2226 | CELEX 32025R1234, OJ L 2025/1234 | 25 June 2025, published 26 June 2025 | [Publications Office][REG 2025/1234] | 29 September 2026 |
| Delegated Regulation (EU) 2026/1359 on the Article 52(4) list | CELEX 32026R1359, OJ L 2026/1359 | 20 March 2026, published 29 June 2026 | [Publications Office][DR 2026/1359] | 29 September 2026 |
| Implementing Decision (EU) 2021/1182, harmonised standards for the MDR, consolidated text | CELEX 02021D1182-20260617, last amendment 2026/1231 | 17 June 2026 | [Publications Office][DEC 2021/1182] | 29 September 2026 |
| Implementing Decision (EU) 2021/1195, harmonised standards for the IVDR, consolidated text | CELEX 02021D1195-20260617, last amendment 2026/1313 | 17 June 2026 | [Publications Office][DEC 2021/1195] | 29 September 2026 |
| Implementing Decision (EU) 2026/1231 amending 2021/1182 | CELEX 32026D1231, OJ L 2026/1231 | 11 June 2026, published 17 June 2026 | [Publications Office][DEC 2026/1231] | 29 September 2026 |
| Corrigendum to Implementing Decision (EU) 2026/1231 | CELEX 32026D1231R(01), OJ L 2026/90511 | 22 June 2026 | [Publications Office][DEC 2026/1231 corr] | 29 September 2026 |
| Implementing Decision (EU) 2026/1313 amending 2021/1195 | CELEX 32026D1313, OJ L 2026/1313 | 15 June 2026, published 17 June 2026 | [Publications Office][DEC 2026/1313] | 29 September 2026 |
| Implementing Decision (EU) 2026/197 amending 2021/1195 | CELEX 32026D0197, OJ L 2026/197 | 28 January 2026, published 30 January 2026 | [Publications Office][DEC 2026/197] | 29 September 2026 |
| Implementing Regulation (EU) 2026/977 on notified body timelines | CELEX 32026R0977, OJ L 2026/977 | Published 5 May 2026 | [Publications Office][REG 2026/977] | 29 September 2026 |
| Regulation (EU) No 1025/2012 on European standardisation, consolidated text | CELEX 02012R1025-20241213, consolidation 003.001 | 13 December 2024 | [Publications Office][Reg 1025/2012] | 29 September 2026 |
| Regulation (EU) 2024/1689 (AI Act), consolidated text | CELEX 02024R1689-20260727, last amendment Regulation (EU) 2026/1744 | 27 July 2026 | [Publications Office][AI Act] | 29 September 2026 |
| Commission proposal COM(2025) 1023 final, 2025/0404(COD), with annexes | Proposal, not adopted | 16 December 2025 | [European Commission][COM 2025/1023]; [annexes][COM annexes] | 29 September 2026 |
| European Parliament Legislative Observatory, 2025/0404(COD) | Page as read | 29 September 2026 | [Legislative Observatory][OEIL] | 29 September 2026 |
| MDCG 2018-1, Basic UDI-DI and changes to UDI-DI | Rev.4 | April 2021 | [European Commission][MDCG 2018-1] | 29 September 2026 |
| MDCG 2018-5, UDI assignment to medical device software | Original | October 2018 | [European Commission][MDCG 2018-5] | 29 September 2026 |
| MDCG 2019-13, sampling for the assessment of the technical documentation | Rev.1 | December 2024 | [European Commission][MDCG 2019-13] | 29 September 2026 |
| MDCG 2020-3, significant changes under MDR Article 120 | Rev.1 (cover date May 2023) | May 2023 | [European Commission][MDCG 2020-3] | 29 September 2026 |
| MDCG 2022-6, significant changes under IVDR Article 110(3) | Original | May 2022 | [European Commission][MDCG 2022-6] | 29 September 2026 |
| MDCG 2021-25, application of MDR requirements to legacy devices | Rev.1 | October 2024 | [European Commission][MDCG 2021-25] | 29 September 2026 |
| MDCG 2022-8, application of IVDR requirements to legacy devices | Original | May 2022 | [European Commission][MDCG 2022-8] | 29 September 2026 |
| MDCG 2022-7, questions and answers on UDI | Original | May 2022 | [European Commission][MDCG 2022-7] | 29 September 2026 |
| MDCG 2021-19, UDI in the quality management system | Original | July 2021 | [European Commission][MDCG 2021-19] | 29 September 2026 |
| MDCG 2026-5, UDI assignment between manufacturers and distributors | Original | July 2026 | [European Commission][MDCG 2026-5] | 29 September 2026 |
| MDCG 2019-9, summary of safety and clinical performance | Rev.1 | March 2022 | [European Commission][MDCG 2019-9] | 29 September 2026 |
| MDCG 2025-10, post-market surveillance | Original | December 2025 | [European Commission][MDCG 2025-10] | 29 September 2026 |
| Team-NB, best practice guidance on technical documentation under the MDR | Version 4 | 21 April 2026 | [Team-NB][TNB MDR] | 29 September 2026 |
| Team-NB, best practice guidance on technical documentation under the IVDR | Version 2 | 3 September 2025 | [Team-NB][TNB IVDR] | 29 September 2026 |
| ISO 20417:2026, catalogue page (status only) | Edition 2 | March 2026 | [ISO][ISO 20417:2026] | 29 September 2026 |
| ISO 20417:2021, catalogue page (status only) | Withdrawn, stage 95.99 | 17 March 2026 | [ISO][ISO 20417:2021] | 29 September 2026 |
| ISO 15223-1:2021/Amd 1:2025, catalogue page (status only) | Amendment 1 | March 2025 | [ISO][ISO 15223-1 Amd 1] | 29 September 2026 |
| European Commission, page of MDCG endorsed documents | Page as read | 27 September 2026 | [European Commission][MDCG endorsed] | 29 September 2026 |
| European Commission, MDR language requirements table | Rev. 3 | August 2025 | [European Commission][EC MDR languages] | 29 September 2026 |

[MDR]: http://publications.europa.eu/resource/cellar/e56fc708-95ab-11f1-9262-01aa75ed71a1.0004.03/DOC_1
[IVDR]: http://publications.europa.eu/resource/cellar/bb7d3f94-cd06-11ef-be2a-01aa75ed71a1.0007.03/DOC_1
[REG 2021/2226]: http://publications.europa.eu/resource/cellar/f5de9cb1-7212-11f0-bf4e-01aa75ed71a1.0008.03/DOC_1
[REG 2025/1234]: http://publications.europa.eu/resource/cellar/3e81e42a-5226-11f0-a9d0-01aa75ed71a1.0006.01/DOC_1
[DR 2026/1359]: http://publications.europa.eu/resource/cellar/1665a3ac-7355-11f1-9800-01aa75ed71a1.0006.01/DOC_1
[DEC 2021/1182]: http://publications.europa.eu/resource/cellar/a74b24b7-74b8-11f1-bf5e-01aa75ed71a1.0004.03/DOC_1
[DEC 2021/1195]: http://publications.europa.eu/resource/cellar/c7c189a9-74b8-11f1-bf5e-01aa75ed71a1.0004.03/DOC_1
[DEC 2026/1231]: http://publications.europa.eu/resource/cellar/badad79f-69e4-11f1-ae88-01aa75ed71a1.0006.01/DOC_1
[DEC 2026/1231 corr]: http://publications.europa.eu/resource/cellar/1cc9cc77-6df8-11f1-ae88-01aa75ed71a1.0006.01/DOC_1
[DEC 2026/1313]: http://publications.europa.eu/resource/cellar/fc1e25f5-69e4-11f1-ae88-01aa75ed71a1.0006.01/DOC_1
[DEC 2026/197]: http://publications.europa.eu/resource/cellar/29b432bb-fd7d-11f0-8da5-01aa75ed71a1.0006.01/DOC_1
[REG 2026/977]: http://publications.europa.eu/resource/cellar/ace4a0e9-481a-11f1-8095-01aa75ed71a1.0006.01/DOC_1
[Reg 1025/2012]: http://publications.europa.eu/resource/cellar/f5b6aa62-ac68-11ef-acb1-01aa75ed71a1.0007.03/DOC_1
[AI Act]: http://publications.europa.eu/resource/cellar/b1730fb2-8f1c-11f1-9262-01aa75ed71a1.0001.02/DOC_1
[COM 2025/1023]: https://health.ec.europa.eu/document/download/25e7ea7c-cab3-40cf-86d9-d11f5e7744d8_en?filename=md_com_2025-1023_act_en.pdf
[COM annexes]: https://health.ec.europa.eu/document/download/dc018bdb-8c09-4a2e-8763-043b594703f7_en?filename=md_com_2025-1023_annex_en.pdf
[OEIL]: https://oeil.secure.europarl.europa.eu/oeil/en/procedure-file?reference=2025/0404(COD)
[MDCG 2018-1]: https://health.ec.europa.eu/document/download/cb1bf6e5-3972-4b3a-82d9-c5946738b2a5_en?filename=md_mdcg_2018-1_guidance_udi-di_en.pdf
[MDCG 2018-5]: https://health.ec.europa.eu/document/download/4b5b2942-aaab-4b78-a188-df111a8d903e_en?filename=md_mdcg_2018_5_software_en.pdf
[MDCG 2019-13]: https://health.ec.europa.eu/document/download/36268741-3591-4130-ad21-b09487ff2074_en?filename=md_mdcg_2019_13_sampling_mdr_ivdr_en.pdf
[MDCG 2020-3]: https://health.ec.europa.eu/document/download/800e8e87-d4eb-4cc5-b5ad-07a9146d7c90_en?filename=mdcg_2020-3_en_1.pdf
[MDCG 2022-6]: https://health.ec.europa.eu/document/download/14c2d8dd-8489-4db5-b035-1c174f17fb54_en?filename=mdcg_2022-6.pdf
[MDCG 2021-25]: https://health.ec.europa.eu/document/download/cbb11a6e-f0f3-4e30-af5e-990f9ef68bc1_en?filename=md_mdcg_2021_25_en.pdf
[MDCG 2022-8]: https://health.ec.europa.eu/document/download/76f9983e-164c-45f1-b2b9-c9e5050cefe9_en?filename=mdcg_2022-8_en.pdf
[MDCG 2022-7]: https://health.ec.europa.eu/document/download/b5429d14-25a9-4cfc-b059-355388f03e05_en?filename=mdcg_2022-7_en.pdf
[MDCG 2021-19]: https://health.ec.europa.eu/document/download/64443e95-e1be-4ffd-80f7-9c6a1b0b99b6_en?filename=md_2021-19_en.pdf
[MDCG 2026-5]: https://health.ec.europa.eu/document/download/f34c1afd-8d01-44cc-bf94-33e4bcac0ef2_en?filename=mdcg_2026-5_en.pdf
[MDCG 2019-9]: https://health.ec.europa.eu/document/download/5f082b2f-8d51-495c-9ab9-985a9f39ece4_en?filename=md_mdcg_2019_9_sscp_en.pdf
[MDCG 2025-10]: https://health.ec.europa.eu/document/download/a9ad86b7-1b8e-4bae-beb4-48b2b3ed2f05_en?filename=mdcg_2025-10_en.pdf
[TNB MDR]: https://www.team-nb.org/wp-content/uploads/2026/04/Team-NB-PositionPaper-BPG-TechnicalDocEU-MDR-2017-745-V4-20260421.pdf
[TNB IVDR]: https://www.team-nb.org/wp-content/uploads/2025/09/Team-NB-PositionPaper-BPG-IVDR-V2-20250903.pdf
[ISO 20417:2026]: https://www.iso.org/standard/88714.html
[ISO 20417:2021]: https://www.iso.org/standard/67943.html
[ISO 15223-1 Amd 1]: https://www.iso.org/standard/86270.html
[EC MDR languages]: https://health.ec.europa.eu/document/download/aa9760e3-c864-4173-8b16-d790dac66d74_en?filename=md_sector_lang-req-table-mdr.pdf
[MDCG endorsed]: https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en