Harmonised Standards under the MDR and IVDR: The Implementing Decisions, the Current List and Presumption of Conformity

Both lists change only through amending decisions, and each amending decision enters into force on the day of its publication in the Official Journal.

The lists matter to everyone who has to show conformity under the two regulations. Manufacturers use them for device requirements, notified bodies take them into consideration in their assessments, and economic operators and sponsors use them for system and process requirements such as quality management, risk management and post-market surveillance.

This page explains the legal definition, what the presumption covers and where Annex Z limits it, and how the two decision chains grew from 2021 to June 2026. It then gives the list size with its withdrawal dates, the status of the main device standards, the state of the art, standardisation request M/575, the court rulings and the pending changes.

What Is a Harmonised Standard?

A harmonised standard, in the sense of the two EU medical device regulations, is a European standard adopted on the basis of a request made by the Commission for the application of Union harmonisation legislation, and only a standard whose reference the Commission publishes in the Official Journal gives presumption of conformity.

An ISO or IEC standard is not harmonised just because it exists. It becomes relevant for the presumption only as a European (EN) standard drafted under a Commission request and listed in one of the two Commission implementing decisions, and only in the version the list names. Both regulations sit in the framework of the EU MDR and IVDR, which define the term in parallel provisions and set the presumption in Article 8 of each regulation.

The Legal Definition and Its Source in Regulation (EU) No 1025/2012

MDR Article 2(70) and IVDR Article 2(73) define a harmonised standard as a European standard as defined in point (1)(c) of Article 2 of Regulation (EU) No 1025/2012. That point reads "a European standard adopted on the basis of a request made by the Commission for the application of Union harmonisation legislation", so the medical device regulations borrow the general EU definition instead of writing their own.

Regulation (EU) No 1025/2012 on European standardisation (OJ L 316, 14.11.2012, p. 12, CELEX 32012R1025 on EUR-Lex) has been in force since 4 December 2012 and has applied since 1 January 2013. Its Article 10(6) is the provision under which the Commission publishes the references of harmonised standards.

Article 10(6) is the legal basis of the Commission decisions that hold the medical device lists, starting with Implementing Decision (EU) 2021/1182. The definition itself sits in Article 2 of the EU MDR (Regulation (EU) 2017/745).

Who Drafts Them: CEN, CENELEC and the Commission Request

CEN develops the harmonised standards for most device types and CENELEC those for medical electrical equipment, both on the basis of a Commission standardisation request. The two European standardisation organisations do not work alone: CEN works in parallel with ISO under the Vienna Agreement of 1991, and CENELEC with IEC under the Dresden Agreement of 1996, reconfirmed in Frankfurt in 2016. Cited references such as EN ISO 13485 and EN IEC 60601-2-83 show this parallel work in their combined prefixes.

Drafts are checked before they reach the list. Up to seven HAS consultants assess draft harmonised standards for medical devices at the First Committee Draft, Enquiry and Formal Vote stages, as MDCG 2021-5 rev.1 (Section 3.2) explains. MDCG guidance is not legally binding (MDR Articles 103 and 105, IVDR Articles 98 and 99).

Presumption of Conformity under MDR and IVDR Article 8

Under MDR Article 8(1) and IVDR Article 8(1), devices in conformity with relevant harmonised standards, or parts of them, whose references are published in the Official Journal are presumed to conform to the requirements of the Regulation covered by those standards or parts.

The presumption runs from the date the reference is published in the Official Journal, not from the adoption date of the decision. MDR Article 8 has applied since 26 May 2021, and the parallel rule for IVDs under the IVDR (Regulation (EU) 2017/746) since 26 May 2022.

What the Presumption Covers: Devices, Systems and Processes

The presumption also covers the system or process requirements that economic operators or sponsors must meet, not only requirements on the device itself. MDR Article 8(1) second subparagraph names quality management systems, risk management, post-market surveillance systems, clinical investigations, clinical evaluation and post-market clinical follow-up (PMCF). A cited quality management standard can therefore support the manufacturer's system, while a cited biological evaluation standard supports a requirement on the device.

IVDR Article 8(1) second subparagraph follows the same structure with the IVD terms: quality management systems, risk management, post-market surveillance systems, performance studies, clinical evidence and post-market performance follow-up (PMPF). Performance studies and clinical evidence take the place of clinical investigations and clinical evaluation in this list, so a cited standard on IVD performance studies supports a sponsor in the same way a clinical investigation standard supports a sponsor under the MDR.

Annex Z and the Limits of the Presumption

A harmonised standard gives presumption only for the requirements its informative Annex Z lists as covered: Annex ZA for the MDR and Annex ZB for the IVDR (MDCG 2021-5 rev.1, Section 2.3). The same guidance states: "Without an adequate Annex Z, a harmonised standard ... cannot be referenced in the OJEU".

A requirement outside Annex Z is not presumed met, even when the standard is cited, and the manufacturer shows it by other means. Annex Z therefore shows the reach of each presumption, since each Annex Z maps clauses to the general safety and performance requirements of Annex I.

Voluntary Use and the Single Exception for Symbols

The use of standards, harmonised or not, is voluntary in the medical device sector, and a manufacturer may use other solutions if it demonstrates compliance (MDCG 2021-5 rev.1, Section 2.2). The guidance words it as "is and remains voluntary", and this holds for cited and uncited standards alike.

The exception concerns symbols and identification colours. Any symbol or identification colour used "shall conform to the harmonised standards or CS" (MDR Annex I Section 23.1(h), IVDR Annex I Section 20.1(h)), and where no harmonised standard or common specification exists, the symbols and colours are described in the documentation supplied with the device.

The Appendix to MDCG 2021-5 of June 2026 calls standards of this kind "compulsory standards". The symbols standard cited for both regulations is EN ISO 15223-1, and which symbols this means is covered under medical device label symbols.

The Two Implementing Decisions and Their Amendments

The Commission publishes the references in two separate Implementing Decisions, (EU) 2021/1182 for medical devices and (EU) 2021/1195 for IVDs, and adds, replaces or deletes entries by amending them. The Commission harmonised standards page lists 11 MDR decisions and nine IVDR decisions, each base decision with its amendments, as of 6 November 2026. The first table traces the MDR chain, the second the IVDR chain, each with the adoption date, the Official Journal reference and the effect on the list.

Table 2: Implementing Decision (EU) 2021/1195 and its eight amendments, as of 6 November 2026.

Implementing Decision (EU) 2021/1182 for Medical Devices

Implementing Decision (EU) 2021/1182 of 16 July 2021 (OJ L 256, 19.7.2021, p. 100), adopted under Article 10(6) of Regulation (EU) No 1025/2012, holds the MDR list and has been amended 10 times, most recently by Implementing Decision (EU) 2026/1231, as of 6 November 2026. The decision has been in force since 19 July 2021. Its first list held five entries, and entry 1, EN ISO 10993-23:2021, was the first harmonised standard ever cited under the MDR.

The list grew through each amendment in Table 1, from five entries in 2021 to entry 65 in June 2026. One amendment reached back in time: the AC:2018 corrigendum to EN ISO 13485, added by Implementing Decision (EU) 2022/757, applies from 5 January 2022, the publication date of the original entry. The current text is the consolidated version 02021D1182-20260617, which integrates all 10 amending acts.

Implementing Decision (EU) 2021/1195 for IVDs

Implementing Decision (EU) 2021/1195 of 19 July 2021 (OJ L 258, 20.7.2021, p. 50) holds the IVDR list and has been amended eight times, most recently by Implementing Decision (EU) 2026/1313, as of 6 November 2026. The decision has been in force since 20 July 2021, and its first list held entries 1 to 4, so the IVDR has had harmonised standards from the start.

IVD-specific entries include EN ISO 17511:2021 from Implementing Decision (EU) 2022/15, EN ISO 20916:2024 from 2024/2625 and the labelling series EN ISO 18113-1 to -5:2024 from 2026/197. The AC:2018 corrigendum to EN ISO 13485, added by 2022/729, applies from 7 January 2022. The current text is the consolidated version 02021D1195-20260617, which integrates all eight amending acts.

The June 2026 Decisions and the Corrigendum

Implementing Decision (EU) 2026/1231 of 11 June 2026 and Implementing Decision (EU) 2026/1313 of 15 June 2026 were both published and entered into force on 17 June 2026. Implementing Decision (EU) 2026/1231 inserts MDR entries 1a, 7a, 12a, 14a and 20a, the versions of existing entries with their 2025 amendments, and adds entries 52 to 65, including EN ISO 10993-1:2025 and EN 60601-1:2006 with A13:2024. Recital 5 of the decision states that EN ISO 10993-1, EN ISO 10993-5 and EN 60601-1:2006, among others, had not been published in the Official Journal in support of the MDR before. The decision also deletes the older versions at entries 1, 7, 14 and 20 from 15 December 2027.

Both June decisions delete EN ISO 15223-1:2021 without its A1 amendment from 17 June 2031, at MDR entry 12 and IVDR entry 8, while the version with A1:2025 sits at entries 12a and 8a. Recital 12 of 2026/1231 gives the reason for the longer period: the "significant impact on economic operators in terms of costs and timing to implement labelling changes". The corrigendum of 22 June 2026 (OJ L 2026/90511) corrected the date in Article 2 of 2026/1231 from "15 June 2031" to "17 June 2031", so both lists drop the old symbols standard on the same day.

The Current List in Numbers

As of 6 November 2026, the MDR list holds 70 references (entries 1 to 65 plus 1a, 7a, 12a, 14a and 20a) and the IVDR list holds 24 references (entries 1 to 23 plus 8a), and no harmonised-standards decision under either regulation has been published after 17 June 2026. The counts fall on two fixed dates: the MDR list drops to 66 references after 15 December 2027, and to 65 MDR and 23 IVDR references after 17 June 2031. Table 3 shows each step with the instrument behind it.

Last checked 6 November 2026; latest decisions 2026/1231 (with corrigendum) and 2026/1313.

Harmonisation Status of the Main Device Standards

Ten widely used device standards and the common specifications each have their own page, and the table shows, for each standard, whether its EN version is cited under the MDR, the IVDR or neither, as of 6 November 2026. A standard without an entry gives no presumption under that regulation, however widely it is used.

Common specifications are not standards. They are adopted by the Commission under MDR Article 9 and IVDR Article 9 and defined in MDR Article 2(71) and IVDR Article 2(74), and the first row of the table leads to their own page.

Table 4: status as of 6 November 2026; "since" is the date the listing decision was published in the Official Journal.

State of the Art and Standards Without an OJ Reference

A standard that is not on either list, or a newer edition than the cited one, gives no presumption of conformity, but it can still be relevant evidence of the state of the art. IEC 62304, EN 62366-1, EN 60601-1-2 and ISO 20417 are examples: none of them is cited under the MDR or the IVDR as of 6 November 2026, and the three sections below explain how such standards are used without a presumption.

The Commission's 2019 Statement on Newest Editions

A Commission statement in the MDCG Subgroup on Standards of 20 May 2019 says that "the most recent editions of standards published by the standardisers should be considered as reflecting state-of-the-art, regardless of the OJ referencing" (MDCG 2021-5 rev.1, Section 3.5). The statement separates two questions: what reflects the state of the art, and what gives a presumption of conformity. Compliance with a newest edition that is not yet cited does not by itself show compliance with the Regulation, because the presumption of MDR and IVDR Article 8(1) attaches only to the version in the list. A manufacturer applying a newer, uncited edition therefore shows conformity on its own evidence.

What Notified Bodies Consider

Notified bodies must, where relevant, take into consideration available CS, guidance and best practice documents and harmonised standards, even if the manufacturer does not claim to be in compliance (MDR and IVDR Annex VII Section 4.5.1).

A manufacturer that does not apply a cited standard shows in its documentation the other solution it uses to demonstrate compliance, and the notified body still takes the harmonised standard into consideration where relevant. How designation and scope work is covered under notified bodies for the MDR and IVDR.

Recording Applied Standards and Following Changes

MDR Annex II Section 4 requires the technical documentation to state the harmonised standards, CS or other solutions applied (point (c)) and the identity of the controlled documents that evidence conformity with each (point (d)).

Standards change after they are applied. Changes in the harmonised standards or CS by reference to which conformity is declared "shall be adequately taken into account in a timely manner" (MDR Article 10(9), IVDR Article 10(8)).

That duty is the basis of a standards-monitoring procedure: each new amending decision, such as the June 2026 decisions with their 2027 and 2031 deletion dates, is a trigger to review the documentation. The full structure is set out under MDR and IVDR technical documentation.

Standardisation Request M/575 and Its Deadlines

Standardisation request M/575, Commission Implementing Decision C(2021) 2406 of 14 April 2021, asks CEN and CENELEC to revise and draft the standards in support of both regulations, and it expires on 31 December 2028. It has been amended twice, by C(2023) 694 of 31 January 2023 and C(2024) 3371 of 27 May 2024. CEN and CENELEC report on progress by 31 October each year and deliver a joint final report by 30 June 2028. The older mandates M/252, M/321 and M/384 expired on 26 May 2022.

The deadlines in the consolidated M/575 request are adoption deadlines for CEN and CENELEC, not dates on which a standard is cited in the Official Journal. The main device standards fall under the two deadlines listed below.

• 27 May 2024: EN ISO 13485, EN ISO 14971, six parts of EN ISO 10993 (-9, -10, -12, -15, -17 and -18) and ISO 10993-23, among other items.
• 27 May 2028: EN ISO 10993-1, the EN 60601 family, EN 62304, EN 62366-1 and EN 80001-1, among other items.

How References Are Published in the Official Journal

Since December 2018 the Commission publishes the references as implementing decisions in the OJ L series instead of communications in the C series, and each decision enters into force on the day of its publication. The last citations under the former Directives appeared in OJ L 90I of 25 March 2020; since then, references for medical devices and IVDs appear in the two decision chains above.

MDCG 2021-5 rev.1 of July 2024, "Guidance on standardisation for medical devices", explains this publication system in Section 3.3. It is listed with the other documents under MDCG guidance.

European Pharmacopoeia (Ph. Eur.) monographs can also count as harmonised-standard references: under MDR Article 8(2), references to harmonised standards include monographs on sutures and on the interaction between medicinal products and materials, if their references are published in the Official Journal. No such reference has been published under the Regulations; the last was under the MDD, in OJ C 369 of 6 December 1997.

Court Rulings on Harmonised Standards

Three judgments shape how harmonised standards are treated, as MDCG 2021-5 rev.1 Section 3.6 summarises them: James Elliott (C-613/14, 27 October 2016), Public.Resource.Org (C-588/21 P, 5 March 2024) and Orona (T-349/21, 13 September 2023). Each judgment answers a different question about the legal nature of a cited standard, as listed below.

• James Elliott (C-613/14): harmonised standards whose references are cited form part of EU law.
• Public.Resource.Org (C-588/21 P): harmonised standards must be accessible.
• Orona (T-349/21): equivalent alternative solutions are allowed.

Pending Changes Affecting Standards

Commission proposal COM(2025) 1023 of 16 December 2025 (procedure 2025/0404(COD)) is pending at the stage "Awaiting committee decision" in the European Parliament's SANT committee as of 6 November 2026, and its past procedural events include a draft report of 30 June 2026; it is not law. Its proposed changes include points that touch standards work.

The proposal would remove the itemised list of quality-management aspects from the manufacturer obligations while keeping the duty to have a quality management system, and it would widen the Commission's power to adopt common specifications. Separately, Regulation (EU) No 1025/2012 is itself the subject of a pending Commission proposal, COM(2026) 780 of 6 October 2026 on European standardisation, which would repeal it. Every amending act and proposal is tracked under MDR and IVDR amendments.

What Harmonised Standards Do Not Do

A harmonised standard gives a presumption of conformity only for the requirements it covers; it does not cover requirements outside its Annex Z, a certificate against it is not an MDR or IVDR certificate, and recognition outside the EU does not make a standard harmonised. The three questions below take each limit in turn.

Does the Presumption Cover the Whole Regulation?

No: the presumption covers only the requirements the standard covers, as stated in its Annex Z (MDR Article 8(1), IVDR Article 8(1)). A device that meets every cited standard still needs evidence for each requirement that no Annex Z covers.

Does Certification to a Standard Replace a Notified-Body Certificate?

No: an ISO 13485 certificate is issued by a certification body and is not an MDR or IVDR certificate, while notified bodies issue EU quality management system certificates (MDR Annex XII Chapter I Section 4(b)).

The certificate types notified bodies issue are explained under MDR and IVDR certificates.

Are FDA-Recognised Standards Harmonised in the EU?

No: only references published in the Official Journal under MDR Article 8(1) or IVDR Article 8(1) count, so recognition by the US FDA gives no presumption of conformity in the EU.