The European Cooperation for Accreditation (EA), an association of national accreditation bodies in Europe, has implemented the accreditation requirements of the International Accreditation Forum (IAF) and has signed up for the IAF Multilateral Recognition Arrangement (MLA) extension to cover ISO 13485. This means that any conformity assessment body (CAB) that is accredited by a European accreditation body will be able to apply the IAF MLA mark to its ISO 13485 certificate. This is like having an accreditation mark recognized by 70 countries.

The IAF vision of “certified once, accepted everywhere” will apply to the medical device industry and its supply chain that relies on ISO 13485. (I covered the details and value of the IAF MLA in an earlier article, “The Beginning of the End for Fake ISO 13485 Certificates.”)

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