EU Health Ministers support proposal to extend transition period for medical devices
Due to the known problems with the implementation of the Medical Devices Regulation (EU) 2017/745 (in short: MDR) as well as the Medical Devices Regulation for in-vitro diagnostics (EU) 2017/746 (in short: IVDR), a corresponding proposal of the EU Commission was presented to the EPSCO meeting today. Almost all member states were in favour of a legal amendment of the transitional periods according to Article 120 (3) as well as the removal of the sell-off regulation according to Article 120 (4) MDR and 110 (4) IVDR.
The background:
At present, 36 notified bodies are designated under the MDR. This is six more than on 14 June 2022. Further 26 applications for designation as notified body are currently being processed; three of them are in an advanced stage.
Based on the feedback received from notified bodies (4) to the latest survey in October 2022, notified bodies have received 8,120 applications from manufacturers and have issued 1,990 certificates under the MDR. According to a rough estimation presented by notified bodies to the MDCG on 17 November 2022, the number of MDR certificates issued by May 2024 may reach around 7,000 if the current rate of certificate issuance continues with no changes to current conditions. This is in stark contrast to 22,793 valid certificates issued under Council Directives 90/385/EEC and 93/42/EEC that will expire by 26 May 2024 at the latest.
As regards Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR), the number of notified bodies designated remains low with only eight notified bodies designated so far; ten applications for designation are in progress, two of them in an advanced stage. Pursuant to the data provided by notified bodies (6) during the survey in October 2022, notified bodies have received 822 applications from manufacturers and have issued 268 certificates under the IVDR. 1,551 valid certificates issued under Directive 98/79/EC will expire by 26 May 2025 at the latest.
The proposal:
· an extension of the transitional period in Article 120(3) MDR with staggered deadlines depending on the risk class of the device. Those deadlines could be 2027 for class III and class IIb devices (i.e. devices with a higher risk) and 2028 for class IIa and class I devices (i.e. lower risk devices) that need the involvement of a notified body in the conformity assessment;
· if needed for legal and practical reasons (including for access to third country markets), the extension of the transitional period could be combined with an extension of the validity of certificates issued under Council Directives 90/385/EEC and 93/42/EEC by amending Article 120(2) MDR;
· conditions to be fulfilled in order to ensure that the extension applies only to devices that do not present any unacceptable risk to health and safety, have not undergone significant changes in design or intended purpose and for which the manufacturers have already undertaken the necessary steps to launch the certification process under the MDR, such as adaptation of their quality management system to the MDR and submission and/or acceptance of the manufacturer’s application for conformity assessment by a notified body before a certain deadline (e.g. 26 May 2024);
· the removal of the ‘sell off’ provision in Article 120(4) MDR and Article 110(4) IVDR.
Regardless of this, it is urgently necessary for all manufacturers to advance the implementation of the MDR in their own companies. We are happy to be at your side and support you both with regard to the implementation of the necessary processes in quality management and with the processing of the technical documentation. Get in touch with us!
