EU Medical Devices Regulation (MDR 2017/ 745 )
date of application (26 May 2021) is just a month away!
With only a month left to go, it comes as no surprise that the date of application of the EU MDR will not be delayed again. Last year, we all received the news of EU MDR date of application being postponed for a year due to the COVID-19 pandemic. Pegah Kiani, Director of Quality Assurance and Medical Devices, highlights what you need to know.
Medical Device Regulation Roll Out
The MDR roll out has continued to be a transitional process. The pandemic affected some of this transition, of course. For example, many MDR audits have been postponed. Although some member states have now stated that they will do remote audits for the MDR. But this naturally does not help those that have Notified Bodies that will not do remote audits for the initial application. Furthermore, EUDAMED (the European Databank for Medical Devices) modules availability have also very much followed the transitional regime.
The EUDAMED Database
European Commissioners are conducting a phased implementation of the EUDAMED database. On 30 October 2019, the Commission published a notice by which it concluded that the full functionality of EUDAMED requires the availability and full operation of all six modules, both individually and jointly. The notice foresees the launch of EUDAMED in May 2022, which correlates with the date of application of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). In this regard, it is important to note that the official launch of EUDAMED in May 2022 does not affect the date of application of the MDR on 26 May 2021. Article 123(3)(d) MDR addresses the possibility that EUDAMED is not fully functional on the date of application of the MDR (26 May 2021).
Accordingly, the obligations and requirements in the MDR that relate to EUDAMED shall apply from the date corresponding to six months after the date of publication of the notice referred to in Article 34(3) – notice of full functionality of EUDAMED. Until EUDAMED is fully functional, the MDR stipulates that the corresponding provisions of Directives 90/385/EEC (Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices, OJ L 189, 20.7.1990, p. 17–36) and 93/42/EEC (Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, OJ L 169, 12.7.1993, p. 1–43) shall continue to apply for the purpose of meeting the obligations laid down in the provisions of Article 123(3)(d) regarding the exchange of information.
In addition, Article 123(3)(e) MDR clarifies that Article 29(4) MDR on the registration of devices, and Article 56(5) MDR on the registration of certificates, start to apply 24 months after the date of publication of the notice referred to in Article 34(3) MDR.
It is important to note, that the Actor registration module in EUDAMED has been functional since December 2020. Details and guidance on this can be found in the Medical Device Coordination Group Document (MDCG 2020-15) Position Paper (md_sector/docs/2020-15) on the use of the EUDAMED actor registration module and of the Single Registration Number (SRN) in the Member States. The UDI/device registration module and Notified bodies and certificates module are expected by (September 2021). The Clinical investigations and performance studies, the Vigilance, post-market surveillance, and the Market surveillance modules are expected by (May 2022).
This transition is made more challenging when taking into account additional aspects. Brexit is a further factor which has resulted in more preparations being required to address changes. If that wasn’t enough, to make matters even more complicated for company’s quality and regulatory processes, there is Swixit and Turkxit to think about too (there will be an article on that coming soon)!
What should you do now?
Keep a close eye on these changes and the various dates. Being prepared is key and time flies as they say! Not only is the date of application of the MDR next month, but the EUDAMED modules will all soon be following suit. So don’t hesitate to reach out for support if you need it. You can contact us through our website (www.s-cubed-global.com) or via email (info @ s-cubed-global.com).