The IAF MLA mark is now available to all CABs accredited by The European Cooperation for Accreditation (EA) Members and is recognized and accepted by all 563 IAF members from 81 countries.
Importance of the IAF Logo
The IAF logo is essential for medical device manufacturers in countries where their accreditation body is not well known on the world stage. It signifies worldwide recognition without any doubt as to legitimacy.
The EA, an association of 50 national accreditation bodies in Europe, has completed the IAF's (International Accreditation Forum) administrative requirements for extending its multilateral recognition arrangement (MLA) to include ISO 13485. In the past, this omission has prevented European medical device exporters from accessing markets such as Australia.
The availability of the IAF logo for ISO 13485 certification means that any conformity assessment body (CAB) accredited by the European accreditation body can apply the IAF MLA mark to their ISO 13485 Certificates.
Logos Commonly Used in ISO 13485 Certificates in Europe
Three logos on ISO 13485 certificates are the new normal in Europe:
- The CAB logo,
- The EA member National Accreditation Body logo and
- The IAF logo.
The Australian Therapeutic Goods Administration (TGA), which previously refused to recognize the legitimacy of ISO 13485 certificates carrying EA member accreditation, now accepts (according to its website) certificates bearing the IAF MLA Mark.
Ask your CAB about adding the IAF MLA logo to your existing ISO 13485 Certificate (yes, we've seewe'vetificaCertificatewe'veentlyne was present despite qualifying for an IAF logo). It is not necessary to wait until the end of your current 3-year contract to do so – it can be done at any time. And may open up new markets for your medical devices or medical device components.
Your follow-up action ...
If ISO 13485 Suppliers present a Certificate that does not include the IAF logo, you must immediately ask questions, as the legitimacy of that Certificate is now in doubt.
If your Company's ISO 13485 Certificate does not include the IAF logo, you must immediately ask your CAB to correct it.
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