Extension of transitional period of Medical Device Regulation (MDR 2017/745)
Medical devices regulation
A proposal for extension of transitional period of Medical Device Regulation (MDR 2017/745) was created by MDCG.
The context :
European regulation RDM 2017/745 relating to medical devices (MD) came into force on May 26, 2021. The new regulations on medical devices have been strengthened in several areas:
- The requirements imposed on manufacturers before marketing a MD have been strengthened. Manufacturers will be required to implement evaluations and clinical investigations to ensure the effectiveness and safety of use of these devices for the benefit of the patient.
- Furthermore, the transparency of data has been reinforced thanks to a new European database called Eudamed, which contains detailed information about medical devices available in Europe and allows, among other things, to know the incidents declared as well as the progress of investigations clinics.
- Finally, the authorization procedures for notified bodies responsible for issuing CE markings and post-marketing market surveillance have been significantly strengthened.
MDR 2017/745 was initially planned for implementation on May 26, 2020. It was postponed for one year due to the major health crisis of COVID-19 in 2020. Indeed, faced with Given the scale of this crisis, the European authorities have decided to postpone the implementation of the MDR by 12 months. This decision was published on April 24, 2020 through Regulation (EU) 2020/561 which amends Regulation (EU) 2017/745 with regard to the dates of application of certain of its provisions including the postponed date of application to May 26, 2021.
Despite everything, the situation remains critical, manufacturers and notified bodies are not ready, which could lead to a severe crisis and shortages of medical devices on the European market... A new amendment is requested...
From national experts and stakeholders, the proposition could include:
- 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 and 2028 for class IIa and class Is/m/r
- If needed for legal and practical reasons, 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 QMS 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
CSDmed is here to support you in the readiness of your technical files and DHFs. With a broad expertise, CDSmed can also help you with responses to NCs.
Don’t wait and contact us