EU Regulatory Output In 2022 To Support MDR And IVDR
There has been a definite slowdown in the last two months in terms of issuing EU regulatory implementation measures. But by how much has the pace changed?
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The latest notified body listing brings total number of EU designated Medical Device Regulation testing and certification organizations to 35.
Work is progressing towards publications of an updated list of standards to support implementation of the EU’s new medtech regulations.
The EU needs to go further when it comes to allowing the use of electronic IFU for all professional use medical devices and fall more closely into line with other global markets.