UNLOCKING LEGALITIES: Challenges And Surprises In The EU Medtech Reg Reform
This article was originally published in SRA
The texts of the new EU medical device and IVD regulations have now been published in their likely final versions, save for the tweaking expected during the European Commission's legal review. Scrip Regulatory Affairs sister publication Clinica asked Erik Vollebregt, partner at Axon Lawyers, what the most significant challenges will be now for the whole of the medtech sector, and where the biggest surprises lie.
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