Today, COCIR* issued a Position paper on the implementation of the future Regulation on Medical Devices (MDR).
The document addresses the transitional period, while putting emphasis on the new changes and challenges for economic operators introduced by the MDR with regard to post-market surveillance, notified bodies, software and chemical substances in MDDs.
It also presents a comprehensible list of new obligations for manufacturers and other economic operators set up by MDR. Moreover, we could only agree with the stated:
“It is therefore of the utmost importance that all Delegated and Implementing Acts, guidance documents and Harmonised Standards are published in good time for economic operators to prepare their own processes and achieve compliance.
Communication and awareness building will be critical in ensuring that all economic operators are aware of their obligations and the relevant deadlines. In addition, there should be a guarantee that there is sufficient capacity to allow manufacturers to obtain Notified Body certificates in a timely fashion.”
We would also like to bring to you attention the recently published Questions & Answers prepared by CAMD** Transition Sub Group related to the MDR. The documents aims to put forward recommendations on the interpretation of the transition-related provisions, namely
Placing on the market of MDR/IVDR compliant devices until 26 May 2020/2022
Placing on the market of AIMDD/MDD/IVDD compliant devices after 26 May 2020/2022
The so called “sell off” provision of Art. 120 para 4 MDR / Art. 110 para 4 IVDR
EUDAMED and its relevance for the application of certain provisions of the MDR/IVDR
*COCIR = European Trade Association representing the medical imaging, radiotherapy, health ICT and electromedical industries
**CAMD = The European Union (EU) Competent Authorities for Medical Devices