EN ISO 13485 and EN ISO 14971: Next Wave Of EU Standards Now Due ‘By December’
The EU Medical Device Regulation applied in May, but the 200 or so associated standards that support it remain in the early stages of preparation. A few have been issued, and now industry can expect a small second wave later in 2021.
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The medtech sector can be hopeful now that the updated medical device risk management standard, EN ISO 14971, will be officially published soon so it can be used to demonstrate compliance with the new EU medical device regulations.
Nearly four months after the full application date of the EU’s Medical Device Regulation, the EU standards bodies have updated the most critical medtech standard to align it with the new EU medtech regulations.
After a long delay, the EU’s first harmonized standards under the MDR and IVDR are trickling through ̶ but the standards situation is still far from ideal.