MDCG Guidance under the MDR and IVDR: The Medical Device Coordination Group and Every Document by Topic

The same group carries out the IVD tasks of IVDR Article 99, and notified bodies take its guidance into consideration under Annex VII Section 1.6.2 of both regulations, which is where the guidance gets its practical weight.

This page sets out who sits in the MDCG, what the two regulations task it with and how much weight its guidance carries. It then lists every referenced document by the topic page that explains it, with the current revision and month, followed by the 13 subgroups, the seven obsolete and five COVID-19 documents, the planned guidance and what the pending proposal COM(2025) 1023 would change for the group.

What Is the MDCG?

The MDCG is the Medical Device Coordination Group, an expert group of the member states' competent authorities, chaired by the Commission, that advises on and coordinates the application of the MDR (Regulation (EU) 2017/745) and the IVDR (Regulation (EU) 2017/746). Its members represent the competent authorities of the member states, and the Commission lists the guidance it endorses.

One group serves both regulations. The MDR and the IVDR entered into force on 25 May 2017; the MDR has applied since 26 May 2021 and the IVDR since 26 May 2022, and both are directly applicable in every member state without national transposition. Because one group works for both, a single MDCG document can cover both regulations, as MDCG 2019-11 rev.1 on the qualification and classification of software does. The group is one of the bodies of the EU MDR and IVDR framework.

Legal Basis: MDR Article 103 and IVDR Article 98

MDR Article 103(1) establishes the MDCG, and IVDR Article 98 gives the same group its tasks under the IVDR, so there is one coordination group for both regulations. IVDR Article 98 does not create a second group: it refers to the MDCG established under the MDR, which carries out its tasks under both regulations with the support of the Commission.

MDR Articles 104, 105 and 107 complete the framework. Under MDR Article 104, the Commission gives the MDCG and its sub-groups technical, scientific and logistic support and organises their meetings. MDR Article 105 lists the tasks, IVDR Article 99 mirrors them for IVDs, and MDR Article 107 sets the conflict-of-interest rule. The wording of both acts is in the consolidated MDR on EUR-Lex and the consolidated IVDR on EUR-Lex.

The MDCG also appears well beyond those articles: 26 provisions of the MDR give it a role, among them Articles 4, 9, 28, 30, 33, 34, 39, 42, 51(3), 54, 55, 93, 106 and 120 and Annexes VII and IX. Under MDR Article 4, for example, the Commission decides the regulatory status of products by implementing acts after consulting the MDCG. The rules on the group itself sit together in Articles 103 to 107 of the EU MDR (Regulation (EU) 2017/745).

Members, Chair and Decisions

Each member state appoints to the MDCG one member and one alternate with medical device expertise and one member and one alternate with IVD expertise, or one member and one alternate for both, for a renewable term of three years (MDR Article 103(2)). The members represent the competent authorities of the member states, so the positions of the group are agreed among national authorities.

A representative of the Commission chairs the MDCG and does not vote (MDR Article 103(5)). The group uses its best endeavours to reach consensus and, where consensus is not reached, decides by a majority of its members; diverging positions may be recorded (MDR Article 103(4)). MDR Article 103(8) requires the MDCG to lay down rules of procedure on four points: the adoption of opinions, recommendations or positions, including in urgent cases; the delegation of tasks to reporting and co-reporting members; the implementation of Article 107 on conflicts of interest; and the functioning of sub-groups.

Tasks under MDR Article 105 and IVDR Article 99

MDR Article 105 gives the MDCG eight tasks, points (a) to (h). The eight tasks are listed below in the order of the article.

• (a) The assessment of notified bodies.
• (b) Advice to the Commission on the coordination group of notified bodies under MDR Article 49.
• (c) The development of guidance.
• (d) Monitoring of technical progress and of the general safety and performance requirements.
• (e) Standards, common specifications and scientific guidelines.
• (f) Assistance to the competent authorities on classification, regulatory status, clinical investigations, vigilance and the market surveillance programme of MDR Article 93.
• (g) Advice on any implementation issue.
• (h) Harmonised administrative practice.

IVDR Article 99 mirrors the same eight tasks for in vitro diagnostic devices, with two references adapted: point (b) refers to the coordination group of notified bodies under IVDR Article 45, and point (f) to market surveillance under IVDR Article 88. Point (c) is the basis of the guidance documents in the register further down this page. For IVDs, the task list therefore sits in IVDR Article 99 of the IVDR (Regulation (EU) 2017/746), not in IVDR Article 98.

Roles in Designating Notified Bodies and Settling Class Disputes

The MDCG has fixed roles in the MDR designation procedure: the Commission appoints a joint assessment team of three experts within 14 days in conjunction with the MDCG (MDR Article 39(3)), and the MDCG issues its recommendation within 42 days of the team's opinion (MDR Article 39(9)). After a body is notified, an objection to the notification is brought before the MDCG within 10 days (MDR Article 42(7)).

Classification questions reach the MDCG through the Commission. A dispute between a manufacturer and its notified body on the class of a device goes to the competent authority of the member state where the manufacturer has its registered place of business (MDR Article 51(2)), while the Commission decides classification questions by implementing acts after consulting the MDCG (MDR Article 51(3)). In market surveillance, MDR Article 105(f) gives the MDCG its role in the programme of MDR Article 93.

How Much Weight MDCG Guidance Carries

MDCG guidance is not legally binding, but notified bodies are required by MDR and IVDR Annex VII Section 1.6.2 to take guidance and best practice documents into consideration, which gives it practical weight in every conformity assessment that involves a notified body. That weight has two sources, the authorities that agree the documents and the notified bodies that apply them, and the sections below take each in turn.

Not Legally Binding, Yet Jointly Agreed

The Commission list of MDCG endorsed documents and other guidance describes its documents as a common understanding, not as law. Its wording is: "The documents on this page are not legally binding. They present a common understanding of how the MDR and IVDR should be applied in practice." The documents repeat the point on their cover. MDCG 2026-6, for example, states: "Any views expressed in this document are not legally binding and only the Court of Justice of the European Union can give binding interpretations of Union law."

The weight of that common understanding comes from who agrees it. MDCG 2019-6 rev.5 (February 2025), the MDCG question-and-answer document on notified-body requirements, states that "all guidance documents endorsed by the MDCG reflect the interpretation of the EU law jointly agreed by the authorities which are in charge of interpreting and applying the EU law". An endorsed document therefore records a position of the competent authorities whose representatives sit in the MDCG under MDR Article 103(2).

Why Notified Bodies Take It into Consideration

Annex VII Section 1.6.2 of both regulations states: "The notified body shall take into consideration guidance and best practice documents." The sentence is identical in the MDR and the IVDR. Its verb is "take into consideration", not "follow" or "comply with", so the section gives guidance weight in the notified body's work without turning a guidance document into a requirement for the device.

MDR Annex IX Section 2.3 adds a second, more specific hook. Its third subparagraph states: "In choosing representative samples, the notified body shall take into account the published guidance developed by the MDCG pursuant to Article 105." The sampling concerns the technical documentation the notified body assesses, and the Commission list holds MDCG 2019-13 rev.1 (December 2024) on sampling of devices for the assessment of the technical documentation.

Where Guidance Sits Next to Standards

A harmonised standard gives a presumption of conformity under MDR Article 8(1) and IVDR Article 8(1), but only for the requirements its Annex Z covers and only once its reference is published in the Official Journal (Implementing Decisions (EU) 2021/1182 for the MDR and 2021/1195 for the IVDR, as amended). MDCG guidance works through a different route: its weight comes from Annex VII Section 1.6.2, not from Article 8. MDCG 2021-5 rev.1 (July 2024), the MDCG guidance on standardisation for medical devices, is itself such a document.

Common specifications are a third instrument. The Commission adopts them by implementing acts after consulting the MDCG (MDR Article 9 and IVDR Article 9), so the group is consulted on an instrument that, unlike its guidance, takes the form of an implementing act. How common specifications under MDR and IVDR Article 9 differ from standards is explained separately.

Expert Panels and EU Reference Laboratories

Two further EU bodies support the conformity assessment of high-risk devices next to the MDCG: expert panels under MDR Article 106 and EU reference laboratories under IVDR Article 100. The conflict-of-interest rule of MDR Article 107(1) covers the experts around the group: members of the MDCG, its sub-groups, the expert panels and the expert laboratories may not have financial or other interests in the medical device industry that could affect their impartiality, a rule that does not apply to stakeholder representatives in sub-groups. The table lists the page for each body with the MDCG documents routed to it.

The MDCG Guidance Register by Topic, as of 2026-11-06

As of 6 November 2026 the Commission list of MDCG endorsed documents and other guidance has 157 rows under 21 topic headings, 147 of them with a reference, and the newest document is MDCG 2026-6 on clinical evidence for orphan IVDs, published on 3 November 2026. Of the referenced entries, 123 are current MDCG numbers; with the seven obsolete numbers, 130 MDCG numbers were issued from MDCG 2018-1 to MDCG 2026-6. The Commission guidance list is the source of every reference and month below.

The five tables group the referenced documents by the page of this site that explains each topic, in the order of a device's life from qualification to post-market duties; the grouping is this site's own and differs from the 21 Commission headings. The list changed through 2026 with the EMDN documents MDCG 2026-1, 2026-2, 2026-3 and MDCG 2021-12 rev.2 (April 2026), MDCG 2021-24 rev.1 and the Manual on borderline and classification v5 (April 2026), MDCG 2025-8 rev.1 (March 2026), the Article 10a Q&A rev.2 (April 2026), the "EU REP" symbol appendix to MDCG 2021-5 rev.1 (June 2026), MDCG 2026-4 (June 2026, rev.1 October 2026), MDCG 2026-5 (July 2026), MDCG 2020-16 rev.5 (September 2026) and MDCG 2026-6.

Product Qualification and Device Groups

Twelve topic pages explain the documents on whether a product is a device, which class it falls into and the rules for software, borderline, Annex XVI, in-house, custom-made and combination products. The current classification guidance is MDCG 2021-24 rev.1 (April 2026) for the MDR and MDCG 2020-16 rev.5 (September 2026) for the IVDR, and MDCG 2019-11 rev.1 (June 2025) covers software. The table gives each page with its documents.

Clinical and Performance Evidence

Eight topic pages cover the documents on clinical evaluation, equivalence, PMCF, clinical investigations, the summary of safety and (clinical) performance, and IVD performance evaluation and studies. The clinical investigation page carries the longest row, while the expert-panel documents sit in the table of the previous section. The table gives each page with its documents.

Notified Bodies, Standards and the Transition

Ten topic pages cover the documents for notified bodies, standards and symbols, and the transition from the directives. The notified-body page holds the longest row, led by MDCG 2019-6 rev.5 (February 2025) as the notified-body Q&A. The table gives each page with its documents.

Operators, Identification, Registration and Labelling

Fourteen topic pages cover the documents on economic operators, UDI, EUDAMED, the EMDN, implant cards and language requirements. MDCG 2018-1 rev.4 (April 2021) is the guidance on the Basic UDI-DI and changes to the UDI-DI, and the EMDN row holds four documents dated April 2026. The table gives each page with its documents.

After Placing on the Market

Three topic pages cover the post-market documents: MDCG 2025-10 (December 2025) on post-market surveillance, MDCG 2022-21 (December 2022, MDR only) on the PSUR, and the vigilance documents led by MDCG 2023-3 rev.2 (January 2025). The Commission list holds no PSUR guidance for IVDs as of 6 November 2026, and it contains no MDCG post-market surveillance plan template. The table gives each page with its documents.

Listed Documents Without an MDCG Number

Not every entry on the Commission list is an MDCG document: the Commission Q&As on Regulations (EU) 2023/607 and 2024/1860, on Article 10a, on the Annex XVI transition and on the EUDAMED roll-out, the Manual on borderline and classification (v5, April 2026) and the Helsinki Procedure (September 2021) carry no MDCG number. They sit in the tables above under the topic they explain, marked "not MDCG-numbered".

The list also holds Commission Guidance 2023/C 163/06 (May 2023) on the content and structure of the summary of the clinical investigation report, the Commission overview of language requirements (January 2024), entries from the EMA, SCHEER and CAMD, and three NBOG documents of February 2018. Ten further rows have no reference at all: six COVID-19 Q&As, three EMDN background documents and the Article 10a decision tree (April 2026). Those ten rows are not in the tables.

How to Read a Reference and a Revision

An MDCG reference has the form "MDCG year-number-revision", for example MDCG 2020-16 rev.5, not "MDCG 2020/16".

The month next to each reference is the month in the Publication column of the Commission list for the current revision, not the month of first issue: MDCG 2020-16 rev.5 shows September 2026 although its number dates from 2020. As of 6 November 2026, the current MDCG numbers per year are eight for 2018, 13 for 2019, 15 for 2020, 27 for 2021, 21 for 2022, seven for 2023, 16 for 2024, 10 for 2025 and six for 2026.

The 13 MDCG Subgroups

The MDCG works through 13 subgroups, all chaired by the European Commission, with members appointed by the member states for three years and stakeholder organisations as observers in 11 of them. The legal hook is MDR Article 103(7), under which the MDCG may establish standing or temporary sub-groups and invite organisations representing industry, healthcare professionals, laboratories, patients and consumers at Union level as observers.

Two subgroups are closed to stakeholders. Notified bodies oversight (NBO) brings together competent and designating authorities, and Market Surveillance brings together competent authorities only. The other 11 subgroups combine competent authorities and stakeholders. The table follows the order of the Commission's MDCG Working Groups page.

Source: Commission MDCG Working Groups page, as of 6 November 2026; legal basis of the subgroups: MDR Article 103(7).

Obsolete and COVID-19 Documents

Seven MDCG documents are archived on the Commission's obsolete-guidance page and are not current guidance: MDCG 2019-4, 2019-5, 2019-10 rev.1, 2020-2 rev.1, 2020-15, 2020-18 and 2021-09. Five of them, on EUDAMED registration timelines and legacy devices, the validity of directive certificates, the class I transitional provisions and the EUDAMED actor module, are listed in the December 2024 column of the obsolete-guidance page. The two UDI position papers on spectacle lenses, contact lenses and ready readers are listed under December 2020 and May 2021.

Five COVID-19 documents are a different case. MDCG 2020-9, 2021-2, 2021-7, 2021-21 rev.1 and 2022-1 remain current under the COVID-19 heading of the Commission list as of 6 November 2026, and no topic page of this site covers them, so they are kept here. The table gives the subject and status of all 12 documents.

Planned Guidance and the Pending Revision

Planned MDCG work appears in a Commission list of ongoing guidance, and the pending proposal COM(2025) 1023 would change the composition and tasks of the MDCG itself. Neither changes the current documents in the register.

The Ongoing-Guidance List

The Commission publishes a list of guidance the MDCG subgroups are developing; the version linked as of 6 November 2026 is dated January 2025. The ongoing-guidance list groups its items by subgroup, such as NBO, PMSV, IVD or Nomenclature. Its items include an update of the MDR clinical evaluation guidance, an update of the MIR form, guidance on Research Use Only devices and a tool for EMDN definitions. These items are planned work, not published guidance.

What the Proposal Would Change for the MDCG

Commission proposal COM(2025) 1023 of 16 December 2025 (procedure 2025/0404(COD)), pending and at the stage "Awaiting committee decision" in the European Parliament's SANT committee as of 6 November 2026, keeps the MDCG but would change its composition and tasks. Its explanatory memorandum describes the MDCG as "retained as the main governing body".

The proposal would have the MDCG members represent the authorities responsible for notified bodies as well as the competent authorities (proposed MDR Article 103(2)). It would create a mandatory sub-group of those authorities and invite observers to the MDCG and its sub-groups: NBCG-Med, industry (in particular SMEs), healthcare professionals, laboratories, patients and consumers. It would replace the eight tasks of MDR Article 105 with one sentence, delete the second sentence of MDR Article 104 and delete IVDR Articles 98 and 99. For notified-body designation, it would set 21 days, extendable once, for the MDCG recommendation that MDR Article 39 sets at 42 days. None of these changes applies today, and every amending act and proposal is listed under MDR and IVDR amendments.

The past procedural events in the European Parliament, as of 6 November 2026, include the announcement of the committee referral on 25 March 2026 and the SANT committee's draft report of 30 June 2026. The proposal text on EUR-Lex and the procedure file 2025/0404(COD) are the primary sources for its wording and its stage.

What MDCG Guidance Does Not Do

MDCG guidance explains the regulations; it does not change them, and it does not certify devices or approve companies. The two questions below set out what follows for a manufacturer that takes a different route and for anyone who looks for an MDCG approval.

Can a Manufacturer Depart from MDCG Guidance?

The obligations are in the MDR and the IVDR, not in the guidance, and the documents themselves reserve binding interpretations of Union law to the Court of Justice of the European Union. The guidance still reaches the assessment: under Annex VII Section 1.6.2 of both regulations, the notified body takes it into consideration when it assesses a manufacturer's documentation, including where the manufacturer meets a requirement of the regulation by another route.

Does the MDCG Certify Devices or Companies?

No: the eight tasks of MDR Article 105 contain no certification of devices or companies; certificates are issued by notified bodies. The MDCG's role in conformity assessment runs through the notified bodies themselves, through their assessment under MDR Article 105(a) and the designation procedure of MDR Article 39.