Who registers the company, its partners and each device, and by when?

Introduction#

Before the first unit of a device is placed on the market in the European Union, meaning first supplied there, a company has to settle three questions. The first is which business in its supply chain holds which legal role, and what each role owes. The second is which identification codes each device carries, and who assigns them. The third is which entries the company and each device need in EUDAMED, the EU's central database for medical devices, and by when. The answers fix the order of work. The company's own registration has to exist before it applies to a notified body, the independent body that certifies a device where the law requires one. The device's registration has to exist before its first unit is placed.

This chapter answers those questions for medical devices and for in vitro diagnostic medical devices (IVDs), the tests run on samples such as blood, including software. It applies the Medical Device Regulation, Regulation (EU) 2017/745 (MDR), and the In Vitro Diagnostic Medical Device Regulation, Regulation (EU) 2017/746 (IVDR).

It uses four illustrative products from across the book. The first two are a wearable cardiac monitor from a company in the United States, and triage software using artificial intelligence (AI) from a German company. The other two are a spinal implant certified under the former EU directive, and a near-patient cardiac troponin test from a Swiss company. That test is a blood test used beside the patient in hospital emergency departments. The law is stated as consolidated on 19 July 2026 for the MDR and on 10 January 2025 for the IVDR. The sources were checked on 29 and 30 September 2026.

1. Which company holds which role, and what does each role owe?#

Under the MDR, the economic operators are the manufacturer, the authorised representative, the importer, the distributor, and the person who combines or sterilises systems and procedure packs under Article 22. The IVDR list has the first four. (MDR Art. 2(35); IVDR Art. 2(28))

(MDR Art. 2(30), 2(32) to (34), 10(7), 11(3), 13(4), 30(2), 31(1); EUDAMED Q&A, Q5)

Our reading is that a contract can allocate the work between these roles, while the regulations decide who is legally answerable for it. A sentence so labelled is the authors' interpretation.

What guidance and Commission pages are worth#

The Medical Device Coordination Group (MDCG), set up under Article 103 of the MDR, is made up of members representing the Member States' competent authorities, the national regulators. Each MDCG document cited here says its views are not legally binding. Each adds that only the Court of Justice of the European Union can give binding interpretations of Union law. (MDR Art. 103(1), (2); MDCG 2022-16, cover page; MDCG 2026-5, cover page)

The Commission's Q&A on the gradual roll-out of EUDAMED states that the Commission has not formally endorsed it, and that it offers no legal advice. Commission web pages and graphics show the Commission's reading on the day they are read. (EUDAMED Q&A, Disclaimer)

The authorised representative#

A manufacturer not established in a Member State may place a device on the Union market only if it designates a sole authorised representative. The mandate is valid only when the representative accepts it in writing. It covers at least all devices of the same generic device group, meaning devices with the same or similar intended purposes or a shared technology. (MDR Art. 2(7), 11(1), (2); IVDR Art. 11(1))

The mandate has to require at least eight tasks. Among them, the representative keeps copies of the declaration and technical documentation for the authorities, and meets the Article 31 registration obligations. It verifies that the manufacturer has met its own obligations under Articles 27 and 29, and passes incident reports to the manufacturer immediately. (MDR Art. 11(3))

The mandate cannot delegate the manufacturer's obligations listed in MDR Article 11(4), and the corresponding IVDR list covers the same obligations. The list includes Article 10(7), the UDI and registration paragraph, so those obligations stay with the manufacturer. A manufacturer outside the Union makes sure its representative has the technical documentation permanently available. (MDR Art. 10(7), (8), 11(4); IVDR Art. 11(4))

Where a manufacturer outside the Union has not complied with Article 10, the representative is liable for defective devices on the same basis as the manufacturer. The two are liable jointly and severally. (MDR Art. 11(5); IVDR Art. 11(5))

A change of representative is set out in an agreement between the manufacturer, the incoming representative and, where practicable, the outgoing one. It addresses at least four points. These are the dates of the two mandates, and the date until which the outgoing representative may still appear in the manufacturer's information. The others are the transfer of documents, and the outgoing representative's duty to forward complaints and incident reports. (MDR Art. 12; IVDR Art. 12)

MDCG 2022-16 adds that a manufacturer may use a different representative for each generic device group. Registration in EUDAMED stays with the manufacturer. A mandate can be ended only for a whole group, unless a specific device is withdrawn from the market. (MDCG 2022-16, s. 4, 5(b), 8)

Importers and distributors#

Before placing a device on the market, the importer verifies the CE marking and the declaration of conformity, and that the manufacturer is identified and has designated an authorised representative. It also verifies the labelling and instructions for use, and the manufacturer's UDI where applicable. It adds its own name and address without obscuring the manufacturer's label. (MDR Art. 13(2), (3))

The importer registers in the actor system before placing a device, verifies that the device is registered, and adds its own details to that registration. Within two weeks of placing a device, it checks that the manufacturer or representative has registered as an actor. If that information is missing or wrong, it tells them and adds its own details. (MDR Art. 13(4), 30(3), 31(1); IVDR Art. 27(3))

Before making a device available, the distributor verifies the CE marking and declaration, the manufacturer's information, the importer's details for imported devices, and the UDI where applicable. For the checks on the CE marking and declaration, the manufacturer's information and the UDI, which are points (a), (b) and (d) of Article 14(2), it may use a representative sampling method. (MDR Art. 14(2))

Both roles keep a register of complaints, non-conforming devices, recalls and withdrawals, and keep storage and transport conditions within those the manufacturer sets. Figure 9.1 sets out what each verifies, records and forwards. (MDR Art. 13(5), (6), (8), 14(3), (5))

Every economic operator has to be able to name to an authority the operators, health institutions and professionals it supplied directly, and the operators that supplied it. Some interruptions or ends of supply could cause serious harm, or a risk of serious harm, to patients or public health. A manufacturer that foresees one gives the competent authority and its direct customers at least 6 months' notice, save in exceptional circumstances. (MDR Art. 10a(1), 25(2); IVDR Art. 10a(1), 22(2))

Who counts as an importer, according to guidance#

(MDCG 2021-27 rev.1, Q2, Q3; MDCG 2025-4, s. 3.1, 3.2)

A device offered online to a person established in the Union has to comply with the MDR. MDCG 2025-4 treats the manufacturer's upload of a software app as placing it on the market. (MDR Art. 6(1); MDCG 2025-4, s. 3)

2. When does a partner become the manufacturer?#

A distributor, importer or other person assumes the obligations of manufacturers if it makes a device available under its own name, registered trade name or registered trade mark. The same applies to anyone who changes the intended purpose of a device already on the market, or modifies it in a way that may affect compliance. (MDR Art. 16(1); IVDR Art. 16(1)(a))

A partner selling under its own name escapes those obligations in one case, where the partner and the manufacturer agree that the manufacturer stays identified on the label and responsible for meeting the requirements placed on manufacturers. MDCG 2018-6 adds that the manufacturer then keeps the UDI obligations. (MDR Art. 16(1)(a); MDCG 2018-6, Art. 16(1))

According to MDCG 2018-6, a partner taking on the manufacturer's obligations registers as a manufacturer, with its own SRN, and takes on the UDI responsibilities. MDCG 2019-7 rev.1 adds that it needs its own person responsible for regulatory compliance (PRRC). (MDCG 2018-6, Art. 16(1); MDCG 2019-7 rev.1, Entities assuming the obligations of a manufacturer)

Translating the manufacturer's information, or changing outer packaging where a Member State needs it and the device's original condition cannot be affected, is not such a modification. A distributor or importer doing either states the activity and its own details on the device, its packaging or an accompanying document. It runs a quality management system, and gives the manufacturer and the competent authority at least 28 days' notice before making the relabelled or repackaged device available. Within that period it submits a certificate for the system from a notified body, a conformity assessment body designated under the MDR. (MDR Art. 2(42), 16(2) to (4))

MDCG 2021-26 says those duties fall on importers and distributors alone. They do not apply to relabelling or repackaging on the manufacturer's behalf and under its control, or a hospital splitting a large pack for use inside it. Nor, it says, do they apply to legacy devices, which section 8 defines. (MDCG 2021-26, s. 2, Q1, Q2)

3. Who is the person responsible for regulatory compliance?#

Each manufacturer has at least one PRRC in its organisation, qualified by a relevant degree and one year's experience, or by four years' experience. A micro or small enterprise may instead have the person permanently and continuously at its disposal. The authorised representative needs its own, permanently and continuously at its disposal. (MDR Art. 15(1), (2), (6); IVDR Art. 15(1))

MDCG 2022-16 and MDCG 2019-7 rev.1 both say the representative's PRRC and a non-Union manufacturer's PRRC cannot be the same person. MDCG 2019-7 rev.1 applies this even inside one large organisation. It adds that the PRRCs of a micro or small enterprise and of its representative may not belong to the same external organisation. (MDCG 2022-16, s. 10; MDCG 2019-7 rev.1, Authorised representative)

The PRRC's name and contact details go into the actor registration. A change to the actor data, such as a new PRRC, is updated within one week. (MDR Art. 31(4); Annex VI, Part A, s. 1; IVDR Art. 28(4); MDCG 2019-7 rev.1, Registration of the PRRC in Eudamed)

4. Which identifiers does a device carry, and who assigns them?#

A UDI is a code that identifies a specific device on the market unambiguously. The word unique does not mean each unit is serialised. UDIs are created under the rules of issuing entities designated by the Commission. Those entities are listed in Implementing Decision (EU) 2019/939, and their designation has been renewed until 27 June 2029. (MDR Art. 27(2); Annex VI, Part C, s. 1; Implementing Decision (EU) 2019/939; Implementing Decision (EU) 2024/2120)

(MDR Art. 27(1), (6); Annex VI, Part C, s. 1; MDCG 2018-1 rev.4, The Basic UDI-DI)

The manufacturer assigns and maintains unique UDIs for its devices. Only the manufacturer may place the UDI on the device or its packaging. MDCG 2026-5 says the manufacturer named on the label is the only entity that can assign UDIs and register the device in EUDAMED. (MDR Annex VI, Part C, s. 2.2, 2.3; MDCG 2026-5, Discussion and conclusions)

MDCG 2026-5 also says one device sold under two trade names may take two UDI-DIs, both assigned by the manufacturer. It adds that a third party may deal with the issuing entities on the manufacturer's behalf. Our reading is that a partner may do the practical work, while the codes and the registrations stay in the manufacturer's name. (MDCG 2026-5, Discussion and conclusions)

When the identifiers are assigned#

Before placing a device on the market, the manufacturer assigns a UDI to it and to each higher level of packaging. It also assigns a Basic UDI-DI and provides it to the UDI database with the core data in Annex VI Part B. (MDR Art. 27(3), 29(1); IVDR Art. 24(3), 26(1))

For the classes and conformity assessment routes in the table below, which chapter 1 sets out, the manufacturer assigns the Basic UDI-DI before it applies to the notified body. The notified body refers to it on the certificate, and confirms in EUDAMED that the certificate information in Annex VI Part A Section 2.2 is correct. The manufacturer then gives the Basic UDI-DI, with the core data, to the UDI database before placing the device. (MDR Art. 29(3); IVDR Art. 26(2))

(MDR Art. 29(3), 52(3), (4); IVDR Art. 26(2), 48(3), (4), (7), (8), (9))

The manufacturer keeps a list of every UDI it has assigned in the technical documentation. It updates the database record within 30 days of a change that does not need a new UDI-DI. A UDI-DI in the database does not mean the device conforms. (MDR Art. 27(7); Annex VI, Part C, s. 5.5, 5.8)

The carrier, and when a new identifier is needed#

The UDI carrier conveys the UDI, for example as a bar code or by radio frequency identification. It goes on the label and on each higher level of packaging, but not on shipping containers. Devices used outside healthcare facilities, such as home care devices, carry the human-readable form even if that leaves no room for the machine-readable one. (MDR Art. 27(4); Annex VI, Part C, s. 1, 4.7, 4.10)

The dates from which devices must bear a UDI carrier are set by class in MDR Article 123(3)(f) and (g) and IVDR Article 113(3)(e). They include 26 May 2025 for MDR class I devices and 26 May 2027 for IVDR class A devices. (MDR Art. 123(3)(f), (g); IVDR Art. 113(3)(e))

A change that could lead to misidentification or ambiguous traceability needs a new UDI-DI. So does a change to a listed data element. The list includes the name or trade name, version or model, sterile labelling, pack quantity, and critical warnings or contra-indications. MDCG 2018-1 rev.4 adds that a change of colour or language might also need one, where it could lead to misidentification or change safety or performance. (MDR Annex VI, Part C, s. 3.9; MDCG 2018-1 rev.4, Changes of UDI-DI)

Software that is sold on its own, or is a device in itself, is assigned its UDI at system level. The UDI also appears in plain text on a readily accessible screen, such as the start-up screen. Software without a user interface can send it through an application programming interface. (MDR Annex VI, Part C, s. 6.5.1, 6.5.4)

(MDR Annex VI, Part C, s. 6.5.2, 6.5.3; MDCG 2018-5, UDI assignment to medical device software)

A distributor or importer relabelling under Article 16(2) keeps the UDI carrier readable, according to MDCG 2018-6. Our reading is that the relabelled device then keeps the manufacturer's UDI-DI. (MDCG 2018-6, Art. 16(2) to (4))

Economic operators and health institutions store the UDI of class III implantable devices they supply or receive. For other devices, Member States encourage, and may require, health institutions and healthcare professionals to store them. Under the IVDR, the duty to store UDIs applies to devices specified by a later measure. (MDR Art. 27(8), (9); IVDR Art. 24(8), (9))

5. What does the company register, and what does the device record hold?#

Before placing a device on the market, manufacturers, authorised representatives and importers register their details in the actor system, unless already registered. The MDR rule excludes custom-made devices. Where a notified body is involved, the manufacturer registers before applying to it. The details include the type of operator, its contact details and the PRRC. (MDR Art. 31(1); Annex VI, Part A, s. 1; IVDR Art. 28(1))

After verifying the data, the competent authority issues the SRN. The manufacturer quotes the SRN when it applies to a notified body, and uses it to access EUDAMED to meet its device registration obligations. The operator records any change to its data within one week, and confirms that the data are accurate within a year of submitting them and every second year after that. The data are public, and the authority may charge a fee. (MDR Art. 31(2) to (8))

MDCG 2021-13 rev.1 says every registered actor gets an actor identifier (Actor ID). It counts as an SRN only for a manufacturer, representative or importer of devices under the MDR or IVDR. An operator of only legacy, old or custom-made devices, or a system or procedure pack producer, gets an Actor ID that is not an SRN. (MDCG 2021-13 rev.1, Terminology, Q8)

The Commission's actor registration page says a manufacturer outside the Union must have an active authorised representative, and submit a mandate summary with its request. (Actor registration page)

The certificate and the device record#

Before placing a device on the market, the manufacturer enters, or verifies, the device data listed in Annex VI Part A Section 2 in EUDAMED, and keeps them updated. The certificate information is the exception, because the notified body enters the information on each certificate it issues. The MDR excludes custom-made devices from this duty. (MDR Art. 29(4), 56(5); IVDR Art. 26(3), 51(5))

The device data include the Basic UDI-DI, the Member State of first placing and the risk class. For MDR classes IIa, IIb and III and IVDR classes B, C and D, they also list the Member States where the device is made available. An IVD's record also says whether the device is new, and whether it is for self-testing or near-patient testing. (MDR Annex VI, Part A, s. 2; IVDR Annex VI, Part A, s. 2)

An IVD is new if no such device was continuously available on the Union market for the analyte in the previous three years. It is also new if its procedure uses analytical technology not continuously used for that analyte on the Union market in that period. (IVDR Annex VI, Part A, s. 2.13)

The Commission Q&A says registration is made at the level of the device identifier. That is the UDI-DI for a device under the regulations, and a EUDAMED identifier (EUDAMED ID) or UDI-DI for a legacy device. Where the first unit with a given UDI-DI is placed on or after the date of mandatory use, the device is registered before that unit is placed. The registration then covers every unit with the same UDI-DI. (EUDAMED Q&A, UDI/Device module, Q7)

6. When does each part of EUDAMED become mandatory?#

EUDAMED holds seven electronic systems, which figure 9.3 sets out. The IVDR has performance studies in place of clinical investigations. (MDR Art. 33(2); IVDR Art. 30(2))

Regulation (EU) 2024/1860 allowed the systems to become mandatory one at a time, where previously none became mandatory until the whole database was functional. (Regulation (EU) 2024/1860, recitals 3 and 4) Each system now becomes mandatory in three steps.

1. The Commission verifies, on independent audit reports, that a system is functional and meets its specifications. (MDR Art. 34(2))
2. It publishes a notice in the Official Journal. (MDR Art. 34(3))
3. The obligations for that system apply from 6 months after publication, and for the IVDR the 6 months also run from the notice published under the MDR. (MDR Art. 123(3)(d); IVDR Art. 113(3)(f))

Until then, the corresponding provisions of the directives continue to apply, including registration of devices and economic operators. (MDR Art. 123(3)(d); IVDR Art. 113(3)(f))

Commission Decision (EU) 2025/2371 confirmed five of the seven systems functional, which the Commission runs as four modules. They are actor registration, UDI and device registration, notified bodies and certificates, and market surveillance. It was published on 27 November 2025, and the Commission states that the four modules have been mandatory since 28 May 2026. (Decision (EU) 2025/2371, Art. 1; EUDAMED overview page)

The overview page says the vigilance module and the clinical investigation and performance study module will be released when mandatory, with no voluntary period. A Commission roadmap of November 2025 placed the vigilance dates in 2026 and 2027, and noted they might be updated. No instrument sets those dates, so the overview page and the roadmap are the sources to check. (EUDAMED overview page; EUDAMED roadmap, November 2025)

Once the vigilance module applies, serious incidents, field safety corrective actions, periodic safety updates and trends are reported through it. A manufacturer that reports such an event also registers the device concerned, unless the device was placed on the market under the directives. (MDR Art. 123(3)(ec); IVDR Art. 113(3)(fd))

7. What deadlines apply to devices and certificates already on the market?#

For a company already placing devices on the market, the obligation to register as an actor applied from the date the actor module became mandatory, as MDCG 2021-13 rev.1 confirms for manufacturers of only legacy devices. Our reading is that the company has no further period in which to register, since the further period in Article 123(3)(e) covers devices only. (MDR Art. 123(3)(d), (e); EUDAMED Q&A, Q3; MDCG 2021-13 rev.1, Q4)

Under the MDR, a device first placed on the market before mandatory use has 12 months from the notice to be registered. The period applies if its units are still being placed on the market once the module is mandatory. The duty covers devices assessed under Article 52 and legacy devices under Article 120(3), (3a) or (3b), other than custom-made devices. A legacy device is excluded where the same device has been assessed under Article 52 and is already registered. Under the IVDR, the period is 6 months from the date the obligations apply. (MDR Art. 123(3)(e); IVDR Art. 113(3)(fa))

The Commission Q&A deals with a device whose units are no longer placed on the market once the module is mandatory. It needs registering only if a post-market surveillance or vigilance action arises. A legacy device needs no registration if the same device is already registered under the regulations. Old devices, which section 8 defines, cannot be registered in the device module at all. (EUDAMED Q&A, Q8, Q14)

The regulations give periods, not dates. As a dated example, an undated Commission timeline graphic shows 28 November 2026 as the deadline for devices placed on the market before mandatory use. The graphic does not separate the MDR from the IVDR. France's Agence nationale de sécurité du médicament et des produits de santé (ANSM) requires registration before 28 November 2026 for devices under the directives with Article 120 transition. The same date applies to devices registered nationally with it. (Commission timeline, legacy and regulation devices; ANSM operator registration page)

Our reading is that the MDR period can end on 27 November 2026, one day earlier, on a strict application of the Union counting rules. Those rules name acts of the Council or the Commission, so applying them to the MDR is itself part of our reading. Registering by 27 November 2026 meets both dates, and the Commission's timeline graphic is the place to check the date the Commission currently gives. (Regulation (EEC, Euratom) No 1182/71, Art. 1, 3(1), (2)(c))

Notified bodies have 18 months from the notice to enter the Article 56(5) certificate information. For devices assessed under Article 52, they enter only the latest certificate and any later decision on it. Under the IVDR they have 12 months from the date the obligations apply. The Q&A says this covers certificates issued under the MDR or IVDR, for devices that need to be or are registered in the device module. Finding no EUDAMED entry for an older certificate therefore proves little on its own. (MDR Art. 123(3)(ea); IVDR Art. 113(3)(fb); EUDAMED Q&A, Q10)

As a dated example, a Commission graphic gives 28 May 2027 as the deadline for entering these older certificates, and MDCG 2026-4 gives 27 May 2027. Our reading is that planning on the earlier of the two dates meets both. On the same reading, a certificate issued under the directives falls outside this duty to enter older certificates, since neither the article nor the Q&A names it. (Commission timeline, certificates; MDCG 2026-4, s. 4)

8. How are legacy and old devices treated?#

MDCG 2021-25 rev.1 describes a legacy device under the MDR as one placed on the market after the MDR's date of application under the Article 120(3) transitional provisions. It holds a valid directive certificate issued before 26 May 2021, or was self-declared as class I under the directive and now needs a notified body. An old device was placed on the market before 26 May 2021. (MDCG 2021-25 rev.1, s. 2.2)

IVDR Article 110(3a) and (3b) cover devices with a directive certificate that remains valid, and devices self-declared under the directive before 26 May 2022 that now need a notified body. MDCG 2022-8 calls these legacy devices, and old IVDs are those placed on the market before 26 May 2022. (IVDR Art. 110(3a), (3b), 113(2); MDCG 2022-8, s. II)

Each Regulation's requirements on post-market surveillance, market surveillance, vigilance, and registration of economic operators and devices apply to its legacy devices. (MDR Art. 120(3d); IVDR Art. 110(3d))

MDCG 2021-25 rev.1 says other MDR requirements should in principle not apply to economic operators for legacy devices, without prejudice to operators choosing to follow them. Its examples include Articles 15, 16(3) and (4), 25, 27 and 32. MDCG 2022-8 takes the same line for legacy IVDs, citing IVDR Articles 15, 16(3) and (4), 22, 24 and 29. (MDCG 2021-25 rev.1, s. 3.1; MDCG 2022-8, s. III.2)

MDCG 2021-25 rev.1 adds that the authorised representative requirement applies to legacy devices, and the MDR UDI requirements do not. (MDCG 2021-25 rev.1, s. 3.1 fn. 7, 3.2)

9. Do national registration duties still apply?#

Member States may keep or introduce national rules on registering distributors. (MDR Art. 30(2); IVDR Art. 27(2))

The Commission Q&A says national requirements may apply until the device module is mandatory. After that, where a device is covered by both a national registration and EUDAMED, the EUDAMED registration becomes the legally required one. It notes that Regulation (EU) 2024/1860 deleted the provisions that had let a EUDAMED registration satisfy national requirements between the notice and mandatory use. (EUDAMED Q&A, Q2 note, Q9)

In France, ANSM's page cites the public health code for two duties. A distributor of medical devices declares its activity, and a manufacturer or representative declares a materiovigilance correspondent. The page covers medical devices under the MDR and says nothing of IVD distributors, so whether the declaration reaches them is a question for ANSM. (ANSM operator registration page; IVDR Art. 27(2))

Our reading is that whether a national registration duty has ceased to apply depends on the national provision on which it rests, which the national authority can confirm.

10. What changes for a manufacturer outside the Union?#

According to MDCG 2022-16, the authorised representative requirement covers medical devices, accessories, the products listed in MDR Annex XVI, IVDs and custom-made devices. The Union market extends to Norway, Liechtenstein and Iceland through the European Economic Area, and to Turkey through the Customs Union. (MDCG 2022-16, s. 1, fn. 1)

The amended standard on label symbols, EN ISO 15223-1:2021/A1:2025, changes the authorised representative's symbol from EC REP, for European Community, to EU REP, for European Union. MDCG guidance calls the change editorial, needing no prior notified body approval. As a dated example, both symbols may be used until 17 June 2031, when the unamended standard leaves the lists. The MDCG appendix and Implementing Decision (EU) 2026/1313 are the sources for that date. (MDCG 2021-5 rev.1 Appendix, The symbol for authorised representatives, Transition period; Corrigendum to Implementing Decision (EU) 2026/1231; Implementing Decision (EU) 2026/1313, Art. 2)

Switzerland has its own rule. Swissmedic, the Swiss regulator, says the Swiss ordinances set duties for a Swiss authorised representative, importer and distributor. It adds that the representative appears next to the CH-REP symbol, for Swiss authorised representative. (Swissmedic, obligations of operators; Swissmedic, CH-REP)

The Artificial Intelligence Act, Regulation (EU) 2024/1689 (AI Act), defines its own operators, separately from the MDR and IVDR, and chapter 10 covers them. (AI Act Art. 3(3) to (7))

11. How the answer is reached#

The answers depend on one another, in this order:

1. The supply chain is mapped first, including whether an app platform acquires ownership of, or another right in, the app. (MDR Art. 2(35); MDCG 2021-27 rev.1, Q2, Q3; MDCG 2025-4, s. 3.1, 3.2)
2. The name on each label decides the manufacturer, unless an Article 16(1)(a) agreement keeps the original one named and responsible. (MDR Art. 16(1); MDCG 2018-6, Art. 16(1))
3. A manufacturer outside the Union needs a written mandate for each whole generic device group. Our observation is that the Article 12 handover terms are easier to agree at the start. A sentence so labelled is a view from practice. (MDR Art. 11(2), (3), 12)
4. The PRRCs are named, and on the guidance's reading the representative's is a different person. (MDR Art. 15(1), (6); MDCG 2022-16, s. 10)
5. The company registers before placing a device and before any notified body application, and keeps its data current. Whether the number it receives is an SRN or only an Actor ID depends on its role and on the devices it deals in. (MDR Art. 31(1), (2), (4), (5); MDCG 2021-13 rev.1, Q8)
6. The identifiers are assigned before the notified body application on the MDR Article 29(3) and IVDR Article 26(2) routes, and otherwise before the device is placed on the market. (MDR Art. 27(3), 29(3); Annex VI, Part C, s. 6.5.2; IVDR Art. 26(2))
7. Each UDI-DI takes a status as a regulation, legacy or old device. That status, together with the date on which its latest unit was placed on the market, decides whether and by when it must be registered. (EUDAMED Q&A, Q7, Q8; MDR Art. 123(3)(e); IVDR Art. 113(3)(fa))
8. The device data are entered before the first unit is placed, and the notified body enters the certificate. (MDR Art. 29(4), 56(5), 123(3)(ea); IVDR Art. 26(3), 51(5), 113(3)(fb))
9. National duties are settled Member State by Member State. (MDR Art. 30(2); EUDAMED Q&A, Q9)
10. The next Commission notice sets new dates, since it starts a new 6-month period for the systems it covers. (MDR Art. 123(3)(d))

12. The four running cases#

The monitor: a wearable cardiac monitor from a company in the United States#

Chapter 1 classes the hardware IIa under Rule 10 on our reading, and the companion application separately. The application is IIa if it only records for later review, and IIb if it analyses the rhythm to guide a physician's diagnosis. The planning assumption is that it only records.

As illustrative assumptions of this book, the monitor is already cleared and selling in the United States. It launches first in Germany and the Netherlands together, through one distributor in each, and later in France.

The triage tool: AI-enabled software from a German company#

Chapter 1 finds class IIa to III all arguable under Rule 11. It plans the tool as class IIb, and that class remains a planning assumption. As illustrative assumptions of this book, its maker is established in Germany, sells directly to hospitals, and also offers the tool through an online app platform.

Registration is made at UDI-DI level. Our reading is that a model update that changes performance creates a new UDI-DI, and so a new device record, before that version is placed on the market. (EUDAMED Q&A, UDI/Device module)

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

Chapter 1 classes the system by component. The interbody cage is class III, screws and plates are IIb, hooks are IIb on MDCG 2021-24 rev.1's reading, and rods, wires and pins are open.

As illustrative assumptions of this book, the system holds a certificate under Directive 93/42/EEC, the former directive on medical devices. That certificate qualifies under Article 120(2), and the company is seeking its first MDR certificate. It is also assumed to have met each Article 120(3c) condition in time, including an MDR application by 26 May 2024 and a written agreement by 26 September 2024. The device is then a legacy device, in MDCG 2021-25 rev.1's terms, to which the MDR registration requirements apply. (MDR Annex VIII, Rule 8; Art. 120(3c)(e), (3d); MDCG 2021-25 rev.1, s. 2.2)

Article 29 began to apply when the module became mandatory, which was after the cage's MDR application had been made. Our reading is that the company keeps any Basic UDI-DI the application named, or assigns one now, and confirms that the certificate will refer to it. (MDR Art. 29(3), 56(5), 123(3)(d))

According to MDCG 2021-26, distributors that translate the instructions for a legacy device do not have the Article 16(3) and (4) duties. Our reading is that those duties start to apply once the device holds its MDR certificate, unless the distributors translate under the company's control. (MDCG 2021-26, s. 2, Q2)

The near-patient test: a cardiac troponin test from a Swiss company#

Chapter 1 gives the test two intended purposes and plans both as class C until a notified body confirms otherwise. This section works on serial measurement, class C under Rule 3(j).

As illustrative assumptions of this book, the test is a legacy device. Its declaration of conformity was drawn up under Directive 98/79/EC before 26 May 2022, with no notified body. The company already sells it through distributors in Germany, the Netherlands, Belgium and Austria. Such a class C device may be placed on the market until 31 December 2028, subject to the Article 110(3c) conditions. At class B, the contested single-measurement reading, the date is 31 December 2029. (IVDR Art. 110(3b), (3d); MDCG 2022-8, s. II)

Our reading is that the test is not new under the first limb of the definition, because cardiac troponin tests are already on the Union market. Whether it is new under the second limb depends on whether its analytical technology has been in continuous use for cardiac troponin in the Union for three years.

13. When specialist help is worth paying for#

• A partner wants its own name on the label, since the Article 16(1)(a) agreement decides who is the manufacturer. (MDR Art. 16(1))
• The company is changing authorised representative, since the Article 12 agreement needs the outgoing party where practicable. (MDR Art. 12)
• The portfolio mixes legacy, old and regulation devices, since each status takes a different registration route. (EUDAMED Q&A, UDI/Device module, Q8)
• The device is sold in several Member States, since national duties rest on national provisions. (MDR Art. 30(2))

Conclusion#

Where the company is established, and whose name is on each label, decide the legal roles. Those two facts settle who is the manufacturer and whether it needs an authorised representative, the EU-based company that a manufacturer outside the EU appoints to act for it. They also settle which distributors count as importers. The manufacturer then assigns the device's identification codes, its unique device identifiers (UDIs). The company registers itself in EUDAMED, the EU's medical device database, before placing a device and before applying to any notified body, the independent body that certifies the device. The device is registered in EUDAMED after its codes are assigned and any certificate is issued, and before its first unit is placed. A device already on the market when device registration became mandatory, and still being placed on it, instead has a set period in which to be registered.

For the wearable cardiac monitor from a US company, this means appointing a sole authorised representative in the EU before any unit is placed. The monitor's German and Dutch distributors buy directly from the US company, so they are importers, and each must register before its first unit. The device is registered before its first unit is placed. The German company's AI triage tool needs no representative. On our reading, an update that changes its performance creates a new device record, needed before that version is placed on the market.

The spinal implant and the near-patient cardiac troponin test are both legacy devices. A legacy device may still be placed on the market on its directive certificate or, for the test, its directive declaration, while the transition conditions are met. Each maker's own registration was due when that part of EUDAMED became mandatory, since units were being placed throughout. Each device is registered within its Regulation's period for devices already on the market, for which the Commission gives 28 November 2026. On our reading the MDR period can end a day earlier, so registering the implant by 27 November 2026 meets both dates. EUDAMED gives every registered party an Actor ID. Whether the makers' Actor IDs count as SRNs, the registration numbers a manufacturer quotes when applying to a notified body, remains open. The Swiss test maker also needs a representative, and must assign the test's Basic UDI-DI, the identifier of the model, before applying to the notified body.