For obvious reasons the medical device sector is one of the most tightly regulated sectors in the world.
The EU MDR will apply fully in EU Member States from 26th May 2021, and with it brings more scrutiny of technical documentation and stricter requirements on clinical evaluation and post-market clinical follow-up as well as better traceability of medical devices through the supply chain.
The full MDR document is over 170 pages long with 123 articles, 10 chapters and 17 annexes … which more than double the number of pages of the Medical Device Directive it replaces! The MDR shifts focus away from the pre-approval stage to a life-cycle approach to medical device regulation.
The new EU MDR also requires medical device manufacturers to have a Quality Management System in place to ensure that devices are produced to an appropriate standard and business activities have the appropriate QMS processes and a post-market surveillance system is set up … and used!
If you are struggling to get to grips with medical device regulations, here are some useful pointers to get you started. Or … get in touch at email@example.com and we can guide you through the process.
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