3/7/2024 0 Comments EN iSO 13485 MEDDEV 2.7.1![]() ![]() Full compliance to both the MEDDEV and MDR is expected by May 26, 2020. That said, Notified Bodies will still expect to see a plan on how the new regulations will be implemented. ![]() Therefore, some Notified Bodies have extended the deadline for implementation of the MEDDEV to match that of the MDR. However, the MEDDEV is a guidance document that is not legally binding. Some Notified Bodies were requiring Clinical Evaluation documents to be compliant to MEDDEV 2.7.1 Rev 4 as early as January 2017. The process now involves two documents the Clinical Evaluation Plan (CEP) and Clinical Evaluation Report (CER). Clinical Evaluation requirements have increased dramatically since the release of MEDDEV 2.7.1 Rev 4 in 2016 and the MDR 2017/745 in May of 2017.
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |