EN ISO 13485 Linked To MDR and IVDR At Last
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.
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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.
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.
Ensuring key standards are available for manufacturers to demonstrate compliance with the MDR and IVDR is one of the top priorities for the European Commission after the summer break.