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ISO 13485:2016

It is suitable only to manufacturers’ inclusion devices on the market in Europe. For the rest of the world, ISO 13485:2016 remainders the appropriate standard. The European standard ISO 13485:2016 Medical Devices, Quality Management Systems, Requirements for Regulatory Purposes, have been available, after approval by CEN on March 2016. This replaces ISO 13485: 2016. The change was prepared as a number of European countries objected to the suggestion that ISO 13485 inferred compliance to the Medical Device Directive (MDD). To solve this problematic, annexes at the beginning of the new standard have now been expanded to link the clauses of ISO 13485 to the Medical Device Directive. Our Notified Body (GMP Certificate.com) states that once ISO 13485:2016 is harmonized there will be no need for current customers with ISO 13485 certificates to suffer an automatic update or rerelease of certification. This is because there is no change in the requirements of the standard. Any existing certificates being renewed or re-released to support changes after this date will be updated at the point of rerelease to also refer to ISO 13485:2016.

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