Europe Signs Multilateral Recognition Arrangement for ISO 13485

Includes a Code of Conduct for notified bodies

Published: Monday, August 31, 2015 - 12:57

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.”)

Many conformity assessment bodies have access to European accreditation through the United Kingdom Accreditation Service (UKAS) and others. There are now 30 countries in Europe that are members of the EA. It is imperative that your conformity assessment body apply to an EA member that is supporting ISO 13485 certification to get the IAF MLA mark.

Having a legitimate IAF MLA mark on an ISO 13485 certificate has not happened yet, but when the EA completes the required assessments and successfully meets the IAF requirements for accreditation, this mark will become a global accreditation mark accepted by the 70 countries that are members of the IAF. It is considered by many to provide the most credible ISO 13485 certification, and one regulator has already signed up to recognize it, even before it has become available. Australia’s Therapeutic Goods Administration (TGA) has determined to accept them, according to their website. Many other regulators in the world are turning to ISO 13485 for regulatory purposes.

How much longer?

Steve Keeling, general manager of the IAF MLA committee, has indicated that the IAF peer evaluation process for the EA could take several more months. The assessments in Europe require assessment teams examining multiple requirements at multiple locations. Accreditation bodies in Europe also accredit notified bodies in Europe related to CE marking, and IAF requirements are now written into the Code of Conduct for notified bodies. All of these requirements strengthen the quality of the auditors that visit medical device firms, whether for CE marking or ISO 13485 certification, but only ISO 13485 certs will be permitted to carry the IAF MLA mark.

Providing an entirely “international” standardized system for accreditation using ISO/IEC standards for accreditation, and activating the enforcement of IAF requirements particular to ISO 13485 provides the broadest recognition of any ISO 13485 certificate. The IAF MLA mark will be the capstone.

This IAF MLA mark is an international accreditation mark recognized by the 70 members of the International Accreditation Forum (IAF).

About The Author

Grant Ramaley

Grant Ramaley is the director of regulatory affairs for Aseptico Inc., a manufacturer and marketer of dental support equipment in the United States and Canada since 1975.  Ramaley also is co-chairman of the Regulatory Affairs and Standards Committee for the Dental Trade Alliance, Convener for the ISO 13485 Working Group at the International Accreditation Forum, and Technical Committee Advisor to the Asian Harmonization Working Party.