The Medical Device Coordination Group (MDCG) has issued another guidance document, MDCG 2021-25.
The document provides further guidance on certain open questions around how Regulation (EU) 2017/745 on medical devices (MDR) applies to legacy devices. It includes an annex with a non-exhaustive table illustrating MDR requirements that apply to legacy devices.
Although the document focuses on the role of notified bodies and their surveillance responsibilities, it is a valuable help for all economic operators. For example, MDCG 2021-25 clarifies that MDR requirements not related to post-market surveillance, market surveillance, vigilance, registration of economic operators and devices should in principle not apply to economic operators in respect to ‘legacy devices.’
This was not entirely clear when looking at the legal text of the MDR. As such, manufacturers are recommended to have a detailed look at the document to complete and supplement their interpretation of the MDR provisions. Please let us know should you wish us to send you a copy. You may also visit our library section for additional relevant documents.
Source: European Commission