According to Article 120 MDR 2017/745 medical devices that have obtained CE Certificate under the MDD 93/42/EEC can circulate in the EU market until the expiration of the Certificate or at the latest until 26th May 2024. Amid this context, the Medical Device Coordination Group released in June 2022 a notice document to manufacturers to ensure they meet MDR requirements from the above-mentioned dates.
The recent situation for Notified Bodies and manufacturers:
At the time of the issuance of the MDCG Position Paper 30 Notified Bodies were handling approximately 80% of the current AIMDD/MDD certificates. At the moment, there are 32 Notified Bodies under MDR. You can find all relevant information on our MDlaw platform in the link here.
The transitional period for legacy devices should not be considered a “grace period” for the manufacturers to postpone the implementation of the MDR requirements but it should provide them time to prepare their documentation before applying it to a notified body.
Considering the data from notified bodies in December 2021 almost 37% of the applications have been rejected based on “incomplete applications”, while in April 2022 75% of the notified bodies stated that more than 50% of the applications were considered “incomplete”.
Possible alternatives and requirements:
Thus, the MDCG notice addresses several solutions to this issue. One choice could be using Article 59 of the MDR in case the MDR compliance process is not completed before the applicable deadline. Article 59 states that a medical device can circulate in the market of a Member State after authorization from the competent authorities even if the MDR compliance process is not completed according to the applicable conformity assessment procedure as indicated in Article 52 MDR.
Concerning this possibility the MDCG position paper notes the following:
- Article 59 states that derogations can only be confirmed by a competent authorityof a member state if the use of the device is in the interest of public health, public safety or patient health;
- This provision should not be used as a back-up mechanism for cases of late submission or delays in the conformity assessment procedure;
- Economic reasons cannot be considered a sufficient ground to justify derogation under Article 59;
- Manufacturers can use mechanisms of Annex VII MDR only under the condition that they have “undertaken all reasonable efforts to successfully conclude the transition to MDR” (MDCG, 2022), while the MDCG notice suggests that for this reason manufacturers should submit the application for certification at least one year before the expiration of the CE Certificate.
Therefore, the MDCG notice urges all manufacturers to ensure they have acquired promptly certification under MDR or at least that they have proceeded with all reasonable efforts to accomplish certification.
Are you a medical devices manufacturer interested in marketing your medical devices in the EU? Contact us now!
Anna KARAVASILI
VIP Department
31/08/2022
References
· BSI. 2022. Manufacturers urged to action on MDR Implementation. Retrieved on 30/08/2022 from https://compliancenavigator.bsigroup.com/en/medicaldeviceblog/manufacturers-urged-to-action-on-mdr-implementation/ .
· MDCG. 2022. MDCG Position Paper Notice to Manufacturers to ensure timely compliance with MDR requirements. Retrieved on 30/08/2022 from https://health.ec.europa.eu/system/files/2022-06/mdcg_2022-11_en_0.pdf.
· European Commission. 2017. REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC. Retrieved on 30/08/2022 from https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017R0745&from=EN.
· Mdlaw. 2022. MDR: 32 Notified Bodies on NANDO. Retrieved on 30/08/2022 from https://mdlaw.eu/mdr/mdr-32-notified-bodies-on-nando/.