The new European medical device regulations (MDR) and in vitro diagnostic regulations (IVDR) will come into force in May 2017, with full implementation deadlines now set for May 2020 and May 2022, respectively.
The MDR will replace the EU’s current Medical Device Directive (93/42/EEC) and the EU’s Directive on active implantable medical devices (90/385/EEC). New legislation governing the EU IVD market will replace the current in vitro diagnostic (IVD) Directive.
Learn about major changes in the regulatory framework and ways in which MedTech manufacturers can make a smooth transition to it here
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