EU Medical Device In Vitro Diagnostic Medical Device Regulations November 2017
The EU’s Regulation (EU) 2017/745 (Medical Device Regulation (MDR)) came into force on 25 May 2017 and will replace the EU’s current Medical Device Directive (93/42/EEC) and the Directive on active implantable medical devices (90/385/EEC). Manufacturers of currently-approved medical devices will have a transition time of three years until May 26th 2020 to meet the …
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