Standardisation for medical devices: time to deliver!

Important news are coming on harmonised standards, standardisation request and guidance

Within the ongoing work for the sound implementation of the new Regulations on medical devices (Regulation (EU) 2017/745 on medical devices - MDR, fully applicable from 26 May 2021, and Regulation (EU) 2017/746 on in vitro diagnostic medical devices - IVDR, fully applicable from 26 May 2022), standardisation represents a very important issue too, especially critical to provide manufacturers as soon as possible with a wide set of effective and state-of-the-art harmonised European standards, adequate to support the legal requirements of the applicable EU Regulations and as such suitable to be cited in the Official Journal of the European Union (OJEU) to confer presumption of conformity. In fact, by using the technical solutions provided by those standards, sectorial manufacturers may lawfully place their devices on the EU-EEA market in a less burdensome manner, at the same time enabling users and patients to benefit from the highest level of safety and performance.

At that respect, three working lines have been especially developed in the last months, proceeding in parallel with the aim to deliver the expected results during the first two quarters of 2021: on one hand, to close the still pending issues with the current Directives on medical devices (Directives 90/385/EEC on active implantable medical devices - AIMDD - and 93/42/EEC on medical devices - MDD, applicable until 25 May 2021, and Directive 98/79/EC on in vitro diagnostic medical devices - IVDMDD, applicable until 25 May 2022), with the publication in the OJEU of the last lists of references of harmonised standards in support of the current Directives; on the other hand, to prepare the necessary legal basis for the development of harmonised European standards in support of the new Regulations, with the adoption and notification of the new MDR/IVDR standardisation request; and finally, to make available overall guidance and clarification on some key issues related to standardisation for medical devices within the EU legislative framework for European standardisation, with the release of a MDCG Guidance document on standardisation for medical devices.

In these efforts, the Commission services count with the precious cooperation of the relevant European standardisation organisations - CEN and Cenelec -, the Committee on Standards established by Regulation (EU) No 1025/2012 on European standardisation, and the Medical Device Coordination Group (MDCG) Subgroups on Standards (WG 2) and on Notified Bodies Oversight (NBO, WG 1), with the sectorial authorities, stakeholders and interested parties, by carring out the appropriate consultations, exchanges of information, discussions etc.

Now is time to deliver:

Harmonised standards in support of the current Directives

The latest publication in the OJEU of references of harmonised European standards in support of the requirements of the current Directives MDD, AIMDD and IVDMDD took place on 25 March 2020 (OJ L 090I, 25.3.2020, pp. 1, 25 and 33) as three Commission Implementing Decisions, according to the new format established by the Commission in 2018 in line with the legal value of standards conferring presumption of conformity according to Regulation (EU) No 1025/2012 on European standardisation and the rulings on standardisation of the Court of Justice of the European Union. In particular, the respective Annexes I contained the consolidated lists of 264 references of standards for the MDD, 46 references of standards for the AIMDD and 41 references of standards for the IVDMDD.

Now, according to the inputs provided by CEN and Cenelec, still in time before the dates of fully applicability of the new Regulations, the Commission is going to further enlarge those lists, by adding 18 references (*) for the MDD, 6 references (*) for the AIMDD and 3 references (*) for the IVDMDD, including both new versions of existing standards and new standards. Among other aspects, these additions should help manufacturers of medical devices in taking advantage from the transitional provisions laid down in Articles 120 of the MDR and 110 of the IVDR concerning validity of certificates until 26 May 2024. The exercise will lead to adopt three Commission Implementing Decisions amending those issued in March 2020 and should be published in the OJEU in March/April 2021 (*), this way configuring the definitive lists of references of harmonised European standards conferring presumption of conformity under the current Directives. Afterwards, all the standardisation efforts will be devoted to provide support to the new Regulations.

(*) edit 6/3/2021

The new MDR/IVDR standardisation request

After the rejection by CEN and Cenelec in June 2020 of the MDR/IVDR standardisation request adopted by the Commission in May 2020, intense work has been carried out to take into due account the concerns and proposals expressed by the standardisation experts and other interested parties, to clarify and solve the questions raised with respect to some parts of that text, within the legal boundaries established by Regulation (EU) No 1025/2012 on European standardisation and the rulings on standardisation of the Court of Justice of the European Union, and considering the specific needs of European standardisation in the field of medical devices, as well as the urgency to positively achieve the exercise, in view of the incoming dates of fully applicability of the new Regulations.

Exchanges, discussions and internal scrutiny led to draft a new MDR/IVDR standardisation request, suitable to be endorsed by the Committee on Standards established by Regulation (EU) No 1025/2012 and accepted by the European standardisation organisations. The draft includes several and significant improvements, addressing in particular the relationship between international and European standardisation; the role of Annexes Z in clarifying the correspondence between the clauses of harmonised standards and the legal requirements, as well as in case of differences in definitions, scope, normative references, etc.; and the lists of standardisation items covered, including existing standards to be revised and new standards to be developed, with an overall total of almost 280 entries in Annexes I and II for the largest possible set of harmonised European standards in support of the new Regulations.

The draft has been submitted to the opinion of the members of the Committee on Standards, by a 4-week written procedure running until 12 March 2021. Once a positive opinion is delivered, the Commission will proceed to adopt the MDR/IVDR standardisation request as Commission Implementing Decision, through a fast-track procedure by the end of March 2021, to inmediately address it to the European standardisation organisations for their acceptance within 1 month from the notification.

Once the MDR/IVDR standardisation request is in force, the Commission will be able to start the regular publications in the OJEU of references of harmonised European standards suitable to confer presumption of conformity under the new Regulations on medical devices. Afterwards, the MDR/IVDR standardisation request, in particular the lists of standardisation items and the deadlines set in Annexes I and II, will be systematically reviewed and updated in line with the market-driven and dynamic nature of standard development both at international and European level, according to the information CEN and Cenelec periodically provide to the Commission: this will ensure that the MDR/IVDR standardisation request remains always aligned to the current state of the art in standardisation for medical devices, thus adequate to provide the sectorial economic operators and the interested parties with the most complete and updated set of harmonised standards conferring presumption of conformity.

MDCG Guidance document on standardisation for medical devices

As announced at the meeting of the MDCG Subgroup on Standards (WG 2) held on 19 June 2020, the Commission has been drafting a "Guidance document on standardisation for medical devices", aiming to become an official document of the Medical Device Coordination Group (MDCG) to provide references and clarification on the EU legislative framework on standardisation for medical devices, in particular on some critical issues for which some confusions and misunderstandings seem to be still present in the sector, such as the voluntary nature of standards, the legal presumption of conformity and the "state of the art", among others.

A first draft of the Guidance document has been circulated for consultation and collection of comments and suggestions to all the members and observers of the concerned MDCG Subgroups on Standards (WG 2) and on Notified Bodies Oversight (NBO, WG 1), until 17 February 2021. On the basis of the contributions received, the Commission is currently elaborating a final draft, to be submitted to the endorsement of the two concerned MDCG Subgroups and then of the MDCG itself, as an official MDCG guidance document (MDCG 2021-xx) to be published in the Commission webpage on Guidance - MDCG endorsed documents. The process should be completed by April 2021.

Updated information on the progress of these exercises will be provided in the next days and weeks, in particular at the meeting between the MDCG and the stakeholders on 4 March 2021 and the meeting of the MDCG on 4-5 March 2021.