Is your company ready for EUs new Medical Device regulations?
In 2017, the EU made the regulatory requirements for Medical device companies stricter by voting to adopt the new legal proposal (1). Already heavily regulated industry is now receiving even more rigorous requirements. The regulatory framework within the EU goes from Directive to Regulation and becomes directly applicable as legislation in all member states. The conditions now also include additional economic operators in the Supply Chain, such as distributors and importers.
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