The European Cooperation for Accreditation (EA), an association of 30 national accreditation bodies in Europe, has completed the administrative requirements of the IAF (International Accreditation Forum) necessary for the extension of their IAF multilateral recognition arrangement (MLA) to include ISO 13485. This omission has in the past, for example, been a barrier for European medical device exporters in gaining access to markets such as Australia.
The IAF MLA mark is now available to all CABs accredited by EA Members, and be recognised and accepted by all 70 countries that are members of the IAF. This is important for medical device manufacturers in countries where their accreditation body is not well known on the world stage. The IAF logo signifies worldwide recognition without any doubt as to legitimacy.
This, in turn, means that any conformity assessment body (CAB) that is accredited by the European accreditation body is able to apply the IAF MLA mark to their ISO 13485 Certificates.
So three logos on ISO 13485 certificates will become the norm in Europe:
- The CAB logo,
- The EA member National Accreditation Body logo and
- The IAF logo.
The Australian Therapeutic Goods Administration (TGA), which previously had refused to recognise the legitimacy of ISO 13485 certificates carrying EA member’s accreditation, now accepts (according to their website) certificates carrying the IAF MLA Mark.
Ask your CAB about adding the IAF MLA logo to your existing ISO 13485 Certificate (yes, we've seen Certificates recently where, despite qualifying for an IAF logo, none was present). It is not necessary to wait until the end of your current 3-year contract to do so – it can be done any time. And may open up new markets for your medical devices or medical device components.
