Updated Version Of EN ISO 13485 Now Officially Harmonized Under MDR Along With Other Standards
The New Year has seen the official publication of a series of long-awaited new medtech standards, including some that are critical to large swathes of the medical device industry.
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The European version of the international risk management standard, EN ISO 14971:2019, may have slipped through the net this January, but the European Commission has just published five new standards harmonized under the IVD Regulation.
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.
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.