Which notified body can assess the device, and how does the work with it run?

Introduction#

This chapter answers which notified bodies can assess a medical device or an in vitro diagnostic medical device (IVD) for the European Union (EU) market, and how the work with the chosen body runs. A notified body is an independent organisation designated under EU law to assess whether a device meets the Regulation. It takes part where the procedure the law sets for the device's class requires one, and after certification it goes on auditing the company.

Two points shape the company's plan. A body may lawfully assess only the types of device listed, in codes, in its designation, so the device's codes decide which bodies are on the shortlist. The date on which the company and the body sign their written agreement also decides which rules govern the quotation, the maximum time for each stage, and how often the body may stop the clock to put questions to the company.

The chapter covers the Medical Device Regulation, Regulation (EU) 2017/745 (MDR), the In Vitro Diagnostic Medical Device Regulation, Regulation (EU) 2017/746 (IVDR), and the Commission's implementing regulations on designation codes and notified body procedures. It applies them to four illustrative products. The first is a wearable cardiac monitor from a United States (US) company, whose hardware is class IIa on chapter 1's reading. Its companion application is planned at class IIa because it only records. The second is artificial intelligence (AI) triage software from a German company, planned at class IIb. The third is a spinal implant system certified under Directive 93/42/EEC, one of the directives the MDR replaced, whose cage is class III. The fourth is a near-patient cardiac troponin test from a Swiss company, planned at class C. The sources were checked on 29 September 2026.

1. When does a notified body take part, and who chooses it?#

A notified body is a conformity assessment body designated under the MDR or the IVDR. It takes part wherever the conformity assessment route for the device's class requires one. Chapter 1 sets out the routes. Those that require a notified body cover MDR classes IIa, IIb and III, three class I cases, IVDR classes B, C and D, and sterile class A. (MDR Art. 2(42), 52; IVDR Art. 2(34), 48)

The manufacturer may apply to a notified body of its choice, provided the body is designated for the types of devices concerned. It may not lodge an application in parallel with another body for the same conformity assessment procedure. (MDR Art. 53(1); IVDR Art. 49(1))

A manufacturer outside the Union may have its authorised representative sign the formal application. The contract itself is concluded directly between the manufacturer and the notified body. (MDR Annex VII s. 4.2(e), 4.3; IVDR Annex VII s. 4.2(e), 4.3)

What the sources are worth#

The MDCG is made up of members appointed by each Member State to represent its competent authorities, and it is chaired by a representative of the Commission. Each MDCG document cited here states that its views are not legally binding. It adds that only the Court of Justice of the European Union can give binding interpretations of Union law. (MDR Art. 103(2), (5))

Team-NB, the European association of medical devices notified bodies, describes its members' application processes in a consensus paper, harmonised where possible. (Team-NB MDR consensus document, V2.1, p. 3)

2. Which bodies can assess the device?#

The notification of a body specifies the scope of its designation, using codes, by conformity assessment activity and by type of device, with any conditions attached. A designation becomes valid the day after the notification is published in New Approach Notified and Designated Organisations (NANDO), the Commission's information system. The body may act only from then. (MDR Art. 42(3), (11), (12); IVDR Art. 38(3), (11), (12))

The codes are listed in Implementing Regulation 2017/2185, Annex I for the MDR and Annex II for the IVDR. Some codes name types of devices, and horizontal codes cover devices with specific characteristics. (Reg. 2017/2185 Art. 1)

(Reg. 2017/2185 Annexes I and II)

Implementing Regulation 2017/2185 does not say which code a given software product needs. MDCG 2021-14 says the IVDR codes may be broad and hard to assign. The manufacturer indicates its device types, and the body usually verifies or assigns the codes at application review. (MDCG 2021-14, sections 1 and 3)

A designation can be narrower than a whole code. The MDCG form for bodies seeking designation asks for limitations where competence cannot be justified for all of it. (MDCG 2021-17, section I) Our reading, a label for our interpretation where the source does not settle the point, is that the codes a manufacturer indicates are only proposals. The manufacturer needs the body to confirm the codes, and any conditions on its designation, before signing the agreement.

The Commission publishes the designated bodies in NANDO, filterable by legislation, and links a June 2025 summary of how widely the codes are covered. (Commission notified bodies page)

As a dated example, that summary records two thirds of MDR codes covered by 35 or more bodies. Five MDR codes, four of them for active implantable devices, were covered by 10 or fewer bodies. Almost half the IVDR codes were covered by all 17 bodies the slide counts, and nine IVDR codes by 10 or fewer bodies. (Coverage of designation codes, June 2025, pp. 2 and 3)

The Commission's 20th notified body survey, with data at 28 February 2026, had responses from 53 bodies. Of those, 34 were designated under the MDR only, 18 under both Regulations, and 1 under the IVDR only. By our computation, a label for arithmetic on the cited figures, that gives 52 bodies under the MDR and 19 under the IVDR. (20th notified body survey, slide 12) NANDO holds the current designations. (Commission notified bodies page)

3. What may the body discuss before and during the assessment?#

A notified body is a third party, independent of the manufacturer, of other economic operators with an interest in the device, and of the manufacturer's competitors. It may still assess devices for competing manufacturers. (MDR Annex VII s. 1.2.1; IVDR Annex VII s. 1.2.1)

The body, its top-level management and its assessment staff may not offer any service that may jeopardise confidence in their independence, impartiality or objectivity. In particular, they offer no consultancy on the design, construction, marketing or maintenance of the devices or processes under assessment. (MDR Annex VII s. 1.2.3; IVDR Annex VII s. 1.2.3)

Those requirements in no way preclude exchanges of technical information and regulatory guidance between the body and a manufacturer applying for conformity assessment. MDCG 2019-6 Rev.5, the MDCG questions and answers on notified body requirements, draws the line between such exchanges and prohibited consultancy in more detail. (MDR Annex VII s. 1.2.9; IVDR Annex VII s. 1.2.9) ISO 13485, named in the table, is the medical device quality management system standard of the International Organization for Standardization.

(MDR Annex VII s. 1.2.3(e), 4.2(d); IVDR Annex VII s. 1.2.3(e), 4.2(d); MDCG 2019-6 Rev.5, Q&As I.6.1 and I.6.2, footnote 4)

MDCG 2024-10 describes orphan devices as devices that by their nature are intended for use in only a small number of individuals each year. (MDCG 2024-10, section 2, p. 4) MDCG 2019-6 Rev.5 describes four checks made before the quotation as legal requirements: whether the Regulations cover the product, its classification, whether it could be an orphan device, and its codes. They are to be discussed in a structured dialogue before the application. (MDCG 2019-6 Rev.5, Q&A I.6.2)

MDCG 2019-6 Rev.5 calls the permitted exchange structured dialogue, and encourages it before and during conformity assessment. It should focus on "what needs to be fulfilled" and leave "how to fulfill" aside. MDCG 2022-14 also encourages such dialogue where useful. In that dialogue, the body should give an overview of the certification process, including timelines and fees. The dialogue's costs should be integrated in the fees for pre-application and assessment work, with no extra fee. (MDCG 2019-6 Rev.5, Q&A I.6.3; MDCG 2022-14, action item 15)

The manufacturer's questions should not be open-ended or expect "how to comply" solutions, so that responsibility for meeting the requirements stays with it. The body should document the main topics exchanged. (MDCG 2019-6 Rev.5, Q&A I.6.3)

Once an application has been lodged, the guidance treats every activity as part of conformity assessment. If the manufacturer withdraws the application, the withdrawal is reported to the other notified bodies. (MDCG 2019-6 Rev.5, Q&A I.6.2; MDR Art. 53(2); IVDR Art. 49(2))

After the application, the guidance says, the parties may exchange views on whether the clinical data behind the clinical evaluation suffice. For an MDR device, that includes whether Article 61(10) applies, equivalence, and whether the post-market clinical follow-up (PMCF) plan is appropriate. Chapter 6 covers clinical evidence. (MDCG 2019-6 Rev.5, Q&A I.6.3)

Implementing Regulation 2026/977 defines the structured dialogue as the exchanges of technical information and regulatory guidance. From 25 February 2027, where Article 8(1) does not exclude the procedure because its agreement was signed earlier, the body's documented procedures for quotations must provide for this dialogue. The dialogue has to cover what is relevant to issuing a quotation, including the information listed in Article 1(1). (Reg. 2026/977 Art. 1(2), 8(1), 9)

4. What does the body need before it quotes, and what does the application contain?#

Where Implementing Regulation 2026/977 applies, a body quotes only once it holds ten listed items of information. They include staff and turnover, to settle whether the manufacturer is an SME, and each site's staff, shifts and activities. They also cover suppliers doing relevant design or manufacture, the devices with their intended purpose and risk class, and any authorised representative. (Reg. 2026/977 Art. 1(1))

For a change or a re-certification, the body does not ask again for the information in points (b) to (g) where the manufacturer confirms it is unchanged. (Reg. 2026/977 Art. 1(1)) Article 1(1)(j) already lets a body ask for other information it needs to estimate the work. Team-NB adds that each body may ask for more than its members' harmonised documents, and should publish what it asks for. (Team-NB MDR consensus document, V2.1, pp. 3 and 4)

The formal application is signed by the manufacturer or its authorised representative. On the Annex IX route, based on the quality management system, it includes each site, the device information and a draft EU declaration of conformity. It also includes the quality system and post-market surveillance documentation. The MDR adds the clinical evaluation plan, and the IVDR the performance evaluation plan. (MDR Annex VII s. 4.3; Annex IX s. 2.1; IVDR Annex VII s. 4.3; Annex IX s. 2.1)

The application declares that no application has been lodged with another body for the same quality system, or gives details of any earlier one. (MDR Annex IX s. 2.1; IVDR Annex IX s. 2.1)

Where the technical documentation is assessed under Annex IX, Chapter II, a second application covers the device and includes its documentation under Annexes II and III. For IVDs for self-testing or near-patient testing, it also covers the aspects in Section 5.1(b). The body may require any information it needs to conduct the procedure properly. Chapter 7 covers the technical documentation. (MDR Annex IX s. 4.1, 4.2; Art. 53(4); IVDR Annex IX s. 4.1, 4.2; Art. 49(4))

The body reviews each application under documented procedures, covering completeness, qualification and class, the chosen procedure, its designation and its resources. It names one individual responsible for the assessment. Refusals and withdrawals are notified to the Union's electronic system, where other bodies can see them. (MDR Annex VII s. 4.3, 4.4; IVDR Annex VII s. 4.3, 4.4)

Implementing Regulation 2026/977 starts its first period when the body receives the "complete application", a phrase it does not define. MDCG 2019-6 Rev.5 starts the post-application phase at receipt, complete or not, so the guidance and the Regulation mark the start at different points. (Reg. 2026/977 Art. 2(2)(a); MDCG 2019-6 Rev.5, Q&A I.6.3, footnote 9)

5. What does the written agreement settle, and why does its date matter?#

The contract between body and manufacturer is a written agreement signed by both, which the body keeps. Its obligations include the manufacturer's duty to inform the body of vigilance reports, and the body's right to suspend, restrict or withdraw certificates. (MDR Annex VII s. 4.3; IVDR Annex VII s. 4.3)

Implementing Regulation 2026/977 applies from 25 February 2027, and its parts apply by reference to different dates.

(Reg. 2026/977 Art. 8(1) to (3), 9)

Article 8(1) and (2) do not mention agreements signed between 25 February and 25 May 2027. A corrigendum, a published correction, of 10 June 2026 changed the German text of Article 8(2). The German text had read "does not apply", and now matches the English "shall apply". (Corrigendum to Implementing Regulation (EU) 2026/977)

For re-certification the signature date makes no difference, because Articles 5 to 7 apply according to the date on which the certificate expires. Where a framework agreement exists between the body and the manufacturer, recital 12 treats the relevant signature as that of the contract for the specific conformity assessment activity. (Reg. 2026/977 recital 12)

On 29 September 2026 the Official Journal, where any amending act would be published, carried none for these dates.

Our reading is that a quotation issued, or a complete application received, before 25 February 2027 may fall outside Articles 1 and 2(2)(a), even with a later agreement. The Regulation does not settle the point, and a body can be asked to state in writing which rules it applies.

For a device with no earlier certificate, signing the agreement on or after 25 February 2027 can bring the procedure under the maximum periods and the interruption rules. Waiting until then also starts the assessment later. Our reading is that this delay has a cost of its own, measured against the planned launch date.

Devices under the transition from the directives#

For a device certified under Directives 90/385/EEC and 93/42/EEC, the manufacturer has largely lost the choice of when to sign. The same is true of a device self-declared under Directive 93/42/EEC before 26 May 2021 whose MDR route needs a notified body. (MDR Art. 120(3b)) Either may be placed on the market or put into service until the transition date that applies to it only if the Article 120(3c) conditions are met. They include an application and an agreement by deadlines that passed in 2024. (MDR Art. 120(3a) to (3c))

In the IVDR, Article 110(3c) sets similar conditions, with dates that depend on the device. On 29 September 2026 one window was still open. It covers class B devices, and sterile class A devices, self-declared under Directive 98/79/EC before 26 May 2022 that now need a notified body. (IVDR Art. 110(3b)(c), (3c)) Their deadlines, 26 May 2027 to apply and 26 September 2027 to sign, fall after 25 February 2027, so the date on which the manufacturer signs within them also decides whether Articles 1 to 3 of Implementing Regulation 2026/977 apply. The current consolidated IVDR gives the transition dates. (IVDR Art. 110(3c)(e), (f); Reg. 2026/977 Art. 8(1))

The body that signed the agreement became responsible for appropriate surveillance of the legacy devices it covers. (MDR Art. 120(3e); IVDR Art. 110(3e)) For the MDR, MDCG 2022-4 Rev.2 uses the term legacy devices for devices placed on the market after 26 May 2021 under the Article 120 transition. It describes appropriate surveillance as, in principle, a continuation of the surveillance under the directives, and says self-declared legacy devices are not subject to it. (MDCG 2022-4 Rev.2, sections 1, 2 and 4.1)

Changing body, and changing the device#

A manufacturer may end its contract and move a device to another body. An agreement between the manufacturer, the incoming body and, where practicable, the outgoing body then sets the arrangements. (MDR Art. 58; IVDR Art. 53)

After certification, the body has procedures and contract terms for assessing changes to the approved quality system or product range, the approved design, the intended use or claims, and the approved type. The manufacturer submits plans for such changes for prior approval. The IVDR list has no item for intended use or claims. (MDR Annex VII s. 4.9; IVDR Annex VII s. 4.9)

A certificate is valid for no more than five years. (MDR Annex VII s. 4.8; IVDR Annex VII s. 4.8)

6. How long may each step take?#

A body must have documented procedures to agree the shortest possible timeline with the manufacturer. (Reg. 2026/977 Art. 2(1)) For procedures to which Articles 1 to 3 apply, Article 2(2) sets four maximum periods for an initial assessment. EUDAMED, in the table, is the European database on medical devices, and chapter 9 covers registration in it.

(Reg. 2026/977 Art. 2(2), 3(1))

The final review comes before the decision. In it, staff who did not carry out the assessment verify that its reports and supporting documentation are complete and sufficient for the scope of the application. (Reg. 2026/977 Art. 2(2)(d); MDR Annex VII s. 4.7; IVDR Annex VII s. 4.7)

The Regulation states its periods in days, without saying whether working or calendar days. Under the Union's general rule on time limits, periods include public holidays, Sundays and Saturdays, except those that expressly exclude them or are expressed in working days. (Reg. 2026/977 Art. 2(2); Regulation (EEC, Euratom) No 1182/71, Art. 1, 3(3)) Our reading is that the periods are calendar days.

Under Annex IX, the audit and the product verification run in parallel, provided the audit programme takes into account the required input from the technical documentation assessment. Unless the parties agree otherwise, both start the day after the contract is signed. (Reg. 2026/977 Art. 2(2))

On that route, with both activities starting the day after signature and no interruption, the counted periods total 170 calendar days, by our computation and on that reading. That is 30, then the longer of 120 and 90, then 20. A period ending on a weekend or public holiday runs to the next working day, adding a day or two. The figure is an upper limit on the periods the body counts for its own work, and does not predict how long a real project will take from start to finish.

The body continues until it decides to issue or refuse a certificate. Expiry of a maximum period, or use of every interruption, is not sufficient reason to refuse. (Reg. 2026/977 Art. 2(4))

Procedures after the first certificate have maximum periods of their own. Those for a change apply where Articles 1 to 3 apply to the procedure, and those for a re-certification apply where the certificate expires on or after 25 November 2027.

(Reg. 2026/977 Art. 2(3), 5(4), 6(1), 7(2), (3))

Once a certificate is issued, the body audits at least once every 12 months under Annex IX. It also makes unannounced audits at least once every five years. (MDR Annex IX s. 3.3, 3.4; IVDR Annex IX s. 3.3, 3.4)

Each body also monitors the share of activities completed within the maximum periods, with median duration and total cost. From 1 January 2028, it publishes on its website by 30 April each year a report on the previous year. (Reg. 2026/977 Art. 4(1) to (4), 9) By our computation, the first reports fall due by 30 April 2028 at the earliest.

What the published figures show#

As a dated example, the 20th survey counts, for the MDR from designation to 28 February 2026, 31,902 applications lodged, 20,698 written agreements signed and 989 applications refused. The applications include changes to certificates, withdrawn and transferred files, and files still open, and exclude pre-application work. (20th notified body survey, slides 15 and 16) By our computation, agreements are 64.9 per cent of applications lodged, and refusals 3.1 per cent. Our reading is that the applications that led to neither an agreement nor a refusal cannot be taken to be stalled.

(20th notified body survey, slides 27, 30, 54 and 55)

The two certificate rows give the share of answering bodies whose time from the signed agreement to a quality management system certificate falls in each band. On our reading of the survey's data date and the Regulation's date of application, the survey's data predate the maximum periods. (20th notified body survey, slide 12; Reg. 2026/977 Art. 9) The Commission's notified bodies page links the current survey. (Commission notified bodies page)

7. When may the body stop the clock?#

Up to the number of interruptions the table in section 6 allows for each phase, the body may interrupt the timeline where the manufacturer has to address non-compliances or answer duly justified questions. Change assessments allow five in total across the review and any further assessment, and one when the supplement is issued. Re-certification reviews allow three. (Reg. 2026/977 Art. 3(1))

The parties may agree a rolling review, submitting the technical documentation in parts, with a plan for the parts and any further interruptions. The body agrees the length of each interruption with the manufacturer and confirms it in writing. (Reg. 2026/977 Art. 3(1))

The clock stops on the day the body sends its requests and, unless agreed otherwise, restarts the day after it receives the answer. An interruption is extended only if duly justified and agreed in writing. (Reg. 2026/977 Art. 3(2), (4))

Where the European Medicines Agency, a regulatory authority, an expert panel or an EU reference laboratory has to give an opinion, the body interrupts the timeline. It tells the manufacturer in writing why, and for how long, and those interruptions are not counted with the others. (Reg. 2026/977 Art. 3(3))

Our reading is that the time a manufacturer takes to answer is the part of each interruption it controls.

8. What will the assessment cost?#

Each notified body establishes a list of its standard fees and makes it publicly available. The Regulations fix no fee and do not say what the list must contain. A body operates on consistent, fair and reasonable terms and, on fees, takes into account the interests of SMEs as defined in Recommendation 2003/361/EC. (MDR Art. 50; Annex VII s. 1.2.8; IVDR Art. 46; Annex VII s. 1.2.8)

(Recommendation 2003/361/EC, Annex, Art. 2)

MDCG 2023-2, the guidance on fee lists, notes that neither Regulation defines "standard fees". A list should be directly accessible on the website registered for the body in NANDO, with no user registration required. (MDCG 2023-2, Introduction; Publication of Lists of Standard Fees)

Fees may be flat or time-based, and justified external costs such as travel should be claimed on top. Where fees depend on other factors, the list should name them and show how SME interests are taken into account, and it may give ranges. (MDCG 2023-2, Scope and explanation)

The cost estimate for a particular device comes in the quotation. Under Implementing Regulation 2026/977 it gives at least the estimated overall costs, split by assessment and including typical surveillance and unannounced audit costs. It also estimates possible extra costs, using hourly fees only where an activity's length cannot be fixed in advance, and gives the estimated timelines. (Reg. 2026/977 Art. 1(3))

The body informs the manufacturer in advance of any increase above 10 per cent of the estimated costs, with the reason. The Regulation requires notice of the increase and sets no cap at 110 per cent of the estimate. (Reg. 2026/977 Art. 1(4))

As a dated example, and not as a sample of the market, four fee lists read on 29 September 2026 show that bodies bill in different units. BSI Group The Netherlands bills audits by the day, NSAI by the day per auditor, SZUTEST by the man-day and the Czech Metrology Institute by the day for one auditor. Documentation review is billed by the day at the first three and by the hour at the Czech Metrology Institute. BSI alone prints a range of days beside its rate. For SMEs, BSI sets annual fees in proportion to device staff, while the other three give percentage discounts. NSAI's list is the one of the four that covers the IVDR. (BSI fee list; NSAI fee list; SZUTEST fee list; Czech Metrology Institute fee list)

None of the lists allows the bodies to be ranked against one another, since an hourly rate and a daily rate cannot be compared without a day count. The Commission's list links the current fee lists. (Commission list of fee hyperlinks)

How audit days are sized#

Three of the four lists name IAF documents as the basis for audit days. (BSI fee list, p. 4; SZUTEST fee list, section C; Czech Metrology Institute fee list, p. 1)

IAF MD 9, an IAF mandatory document, sets criteria for accredited certification bodies that audit quality management systems to ISO 13485. Its Table D.1 is a starting point for an initial ISO 13485 certification audit, and leaves out design dossier reviews. (IAF MD 9:2023, clause 1) The table gives audit days according to the effective number of personnel, a headcount that includes part-time and temporary staff and those on each shift. It gives, for example, 5 days for 16 to 25 personnel. (IAF MD 5:2023, clause 1.9; IAF MD 9:2023, Annex D, Table D.1)

(IAF MD 9:2023, Annex D, clause MD 9.1.4; IAF MD 5:2023, clause 5)

Our reading is that the MDR and the IVDR are regional regulatory requirements in that sense, so the table's figure is likely to understate the days an MDR audit needs.

Our reading is that ISO 13485 certification and notified body assessment are different activities, since the guidance allows voluntary ISO 13485 certification before an application. (MDCG 2019-6 Rev.5, Q&A I.6.2, footnote 4) On that reading, Table D.1 is only a planning input, and the manufacturer cannot rely on it as entitling it to a particular number of audit days. The days for the documentation review come from the body's published range or from its quotation.

A pending proposal, COM(2025) 1023, would cut fees for micro and small manufacturers and orphan devices, and let the Commission set the level and structure of fees. It would also put structured dialogue into Annex VII. (COM(2025) 1023, explanatory memorandum and recital 28) On 29 September 2026 the procedure was awaiting a committee decision, and a proposal is not law; the Legislative Observatory file records its progress. (Legislative Observatory, 2025/0404(COD))

9. How the answer is reached#

The answers depend on one another, in this order:

1. The route decides whether a body takes part. Where it names none, the manufacturer declares conformity after drawing up the technical documentation. (MDR Art. 52(7); IVDR Art. 48(10))
2. The codes follow from the device, as proposals the body checks at application review. (Reg. 2017/2185 Annexes I and II; MDR Annex VII s. 4.3; MDCG 2021-14, section 3)
3. The longlist is the bodies whose notified scope includes every code the device needs, with no condition that excludes the device. (Commission notified bodies page; MDR Art. 42(3); Coverage of designation codes, June 2025)
4. The fee lists give rates, units, ranges and SME terms, each as of its effective date. (Commission list of fee hyperlinks; MDCG 2023-2, Scope and explanation)
5. The quotation rests on the Article 1(1) information, plus what the body's procedure adds, with SME status counted under the Recommendation. (Reg. 2026/977 Art. 1(1); Team-NB MDR consensus document, V2.1, pp. 3 and 4; Recommendation 2003/361/EC, Annex)
6. The structured dialogue settles, in closed questions, whether the Regulation covers the product, its class, whether it could be an orphan device, and its codes; after the application, it can also address whether the clinical data suffice. (MDCG 2019-6 Rev.5, Q&As I.6.2 and I.6.3)
7. Where Articles 1 to 3 apply, quotations can be compared on the contents Article 1(3) requires, from estimated costs for each assessment to estimated timelines. (Reg. 2026/977 Art. 1(3), 8(1))
8. Each cost line is a rate multiplied by a quantity with a stated source, with IAF MD 9 days used only as a planning input, and surveillance, unannounced audits and travel as lines of their own. (IAF MD 9:2023, clauses 1 and MD 9.1.4; MDR Annex IX s. 3.3, 3.4)
9. The signature date is weighed against the transition and Implementing Regulation 2026/977 dates, and where the device relies on a transition, its conditions and deadlines must be met first. (MDR Art. 120(3c); IVDR Art. 110(3c); Reg. 2026/977 Art. 8, 9)
10. One formal application goes to one body, and where Articles 1 to 3 apply, the first period starts when the body receives it complete. (MDR Art. 53(1), (3); Annex VII s. 4.3; Reg. 2026/977 Art. 2(2)(a), 8(1))
11. The working rules are agreed at the start: the responsible individual, any rolling review plan, and interruptions confirmed in writing. (MDR Annex VII s. 4.4; Reg. 2026/977 Art. 3(1), (2))

10. The four running cases#

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

On our reading in chapter 1, the hardware is class IIa under Rule 10. The companion application, classified separately, is planned at class IIa because it only records. If it analysed the rhythm to guide a physician's diagnosis, it would be class IIb, and the body would then sample the technical documentation per generic device group. (MDR Art. 52(4)) At class IIa, a body audits the quality system on the Annex IX route, and assesses the technical documentation of at least one representative device for each category. (MDR Art. 52(6))

Illustrative cost on one fee list. As an illustrative assumption, the company has 20 effective personnel on one site and is costed on BSI's list. Each amount is our computation of rate times quantity, and none is a price for the monitor. The clinical evaluation assessment report is where the body records its conclusions on the clinical evaluation. (MDR Annex VII s. 4.6)

(BSI fee list, pp. 2 and 3; IAF MD 9:2023, Annex D; IAF MD 5:2023, clause 5; MDR Annex IX s. 3.3, 3.4)

By our computation, with flat fees at their base and day ranges at both ends, the first five lines total EUR 33,122 to 69,410. That is before annual fees, surveillance, unannounced audits and travel. Our reading is that the audit line is likely to be too low, since its day count leaves out time to audit MDR requirements, and that the documentation review line has the widest spread.

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

Classes IIa to III are all arguable under Rule 11, and chapter 1 plans the triage tool at class IIb. On that plan, a body assesses at least one representative device per generic device group. That is a set of devices with the same or similar intended purposes, or a commonality of technology, that allows them to be classified in a generic manner. (MDR Art. 52(4), 2(7); IVDR Art. 2(8))

What the AI Act adds is in chapter 10, on AI and cybersecurity.

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

Chapter 1 classes the system by component. The cage is class III, the screws and plates class IIb, and the hooks class IIb on MDCG 2021-24 rev.1's reading. Rule 8 does not name the rods, wires and pins, so their class is open. As an illustrative assumption of this book, the system was CE marked under Directive 93/42/EEC as a non-active implant. It now seeks its first MDR certificate.

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

Chapter 1 plans the test at class C for both its intended purposes until a notified body confirms otherwise. This case takes the serial-measurement purpose, class C under Rule 3(j), so a body assesses at least one representative device per generic device group. As an illustrative assumption of this book, the test is a legacy device sold into several Member States through distributors. It was declared conforming under Directive 98/79/EC before 26 May 2022 with no notified body. (IVDR Art. 48(7))

11. When specialist help is worth paying for#

• The device relies on an Article 120 or Article 110 transition, where whether it may stay on the market depends on meeting the transition conditions and dates. (MDR Art. 120(3c); IVDR Art. 110(3c))
• The company wants to change body, since the Article 58 agreement affects certificates and surveillance. (MDR Art. 58, 120(3e))
• Few bodies hold the device's codes, or a body takes a different view of the device's class. Chapter 1 covers how a class dispute is decided.
• The body's terms on fees, termination and liability matter to the business, before signature.
• SME status depends on linked or partner enterprises, under the Recommendation's counting rules. (Recommendation 2003/361/EC, Annex)
• Interruptions keep recurring, or the body signals a refusal. The body continues past its maximum periods until it decides, and a refused application is notified to other bodies. (Reg. 2026/977 Art. 2(4); MDR Annex VII s. 4.3)

Conclusion#

The device's class decides whether a notified body, the independent organisation that assesses the device against the Regulation, takes part. The company applies to one body whose designation codes, the list of device types it may assess, include every code the device needs. On our reading, the body should confirm those codes before signature.

Before the application, in what the guidance calls a structured dialogue, the body confirms whether the Regulation covers the product, its class, whether it could be an orphan device, and its codes. An orphan device is one intended for use in only a small number of individuals each year.

The signature date of the written agreement decides whether the rules of Implementing Regulation 2026/977 on quotations, maximum periods and interruptions apply. Those rules do not apply where the agreement was signed before 25 February 2027. For a device with no earlier certificate, signing on or after that date can bring those limits into play, but waiting also starts the assessment later. On our reading that delay has a cost of its own, measured against the planned launch date. For a legacy device, one kept on the market under the older directives' transition, the deadlines for the application and the agreement have largely fixed that date.

In the running cases, the companion application of the wearable heart monitor from a US company needs, on our reading, the software codes MDA 0315 and MDS 1009. Its shortlist is then the bodies that also hold the hardware code. By our computation, the five first-certificate fee lines on the list of BSI, one notified body, total EUR 33,122 to 69,410. That illustration is no price for the monitor and excludes annual fees, surveillance, unannounced audits and travel.

The spinal implant system's 2024 agreement leaves its procedure outside those newer rules. Its class III cage goes through the clinical evaluation consultation procedure of Article 54, in which an expert panel may give a scientific opinion. The cardiac troponin test from a Swiss company is a legacy device. To stay on the market until 31 December 2028 at class C, it had, among other conditions, to apply by 26 May 2026 and sign by 26 September 2026, so those deadlines fixed its signature date.

Chapter 6 covers clinical evidence, chapter 7 technical documentation, chapter 9 registration in EUDAMED, the European database on medical devices, and chapter 10 the AI Act.