News Category: Regulatory news
The Competent Authorities for Medical Devices (CAMD) has published a statement about the transition to the Medical Devices Regulation (MDR) and the capacity of the medical device system. This statement follows discussions at the CAMD’s 50th plenary meeting on 3 June 2022 and is relevant to all stakeholders.
In this statement, the CAMD:
- Recognises the urgent challenges relating to sector capacity and readiness ahead of May 2024 (notified body certificates issued in accordance with the previous directives will become void from this date) which, if left unaddressed, may affect the supply of critical and innovate devices to the EU market.
- Outlines their commitment to work with EU colleagues and relevant stakeholders to find solutions to these challenges and to prevent supply disruptions.
- Agrees that solutions should focus on getting manufacturers on the road to compliance and should not generally involve a reinterpretation of MDR requirements or derogations issued by national competent authorities.
- Proposes that work on finding solutions to these challenges is progressed urgently.
Please note that this is a summary of the CAMD statement. For a more comprehensive overview of its information, please review the statement in full.
CAMD certificates of free sale Q&A
The CAMD has also published a Q&A document entitled Questions and Answers on Certificates of Free Sale and Article 60 of Regulation (EU) 2017/745 on medical devices (MDR).
The aim of this document is to provide guidance in the area of certificates of free sale. It considers how certificates of free sale should be processed or generated for ‘legacy’ and MDR-compliant devices. It highlights where certificates of free sale can be issued in the context of Article 60 (1) of the Regulation and where the use of national provisions may be required.
We encourage engagement from all stakeholders. If you have any questions about legislative requirements or the implementation of the MDR please email us at firstname.lastname@example.org.