22 February, 2017

TO ALL CERTIFICATION BODIES DELIVERING 1SO 13485 CERTIFICATION:

PUBLICATION OF NEW IAF INFORMATIVE DOCUMENT ON INTERNATIONAL MEDICAL DEVICE NOMENCLATURE (IAF MDN) – IN SUPPORT OF ISO 13485 CERTIFICATION.

In October 2016 IAF approved ID13 International Medical Device Nomenclature (IAF MDN) Including Medical Device Risk Classifications, Issue 1. This was published as an Informative Document on 30th January 2017 and is intended to reflect the consensus of IAF members on this subject and to support the consistent application of requirements. However, its implementation is not mandatory and therefore accreditation bodies and certification bodies are not under any obligation to use or comply with its contents. As a consequence UKAS will not be expecting any changes to CB management systems or certification delivery.

UKAS voted in favour of this document as a tool to help promote consistency with nomenclature and risk classification for medical devices. It is intended that this document will facilitate the exchange of information on medical devices on a global level.

The document is available from the IAF website.