» Technical Bulletin – Medical Devices Certification – IAF MD9:2017
29 August, 2017
This bulletin applies to Management Systems Certification to ISO 13485 for Medical Devices in accordance with ISO/IEC 17021-1.
IAF MD 8 & IAF MD 9 were re-issued on 9th June 2017 with an application date of 9th June 2018.
This communication identifies the steps needed to implement these new mandatory documents and in particular the implementation of MD9 by accredited certification bodies.
With immediate effect, UKAS will be using these documents as part of the ISO 17021-1:2015 /ISO 13485 assessments. All affected certification bodies will be expected to have adopted IAF MD 9:2017 no later than 9th June 2018.
It should be noted that IAF MD 9:2017 has introduced a new main technical area: 1.7 - Parts & Services. Those certification bodies wishing to add this new technical area to their current schedule of accreditation are required to submit an application for extension to scope.
It is expected that this extension will be completed via a desk top review exercise; therefore applications will need to include details of the CB’s technical competence criteria and demonstration of competence for relevant certification staff. The effort required to undertake this review is expected to be between 0.5 - 0.75 days.
CBs are invited to submit applications for this extension immediately.
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