We are pleased to confirm that our Belgian Notified Body has been designated by the European Commission and Belgian Competent Authority (FAMHP) under Medical Device Regulation (EU) 2017/745.
In May 2021, the Medical Device Regulation (MDR) officially replaced the Medical Device Directive (MDD) with the aim to enhance safety for European patients through a more robust and transparent framework. Also, it brings medical devices regulation into line with technical advances, changes in medical science and progress in law making.
Our team has worked hard over the past years to prepare for the change and is now officially a European MDR Notified Body. Find the official designation here.
Jeffrey McDonald, EVP, SGS Knowledge Solutions, said, “We are delighted to have been appointed as a designated Notified Body under the European MDR and look forward to working with both existing and new clients to implement this demanding new regulation. With our existing approvals under the UKCA scheme, SGS is one of the few companies that can provide certification services for medical devices across the whole of Europe."
SGS’s service scope remains the same and so our team is pleased to offer manufacturers MDR CE certification starting from November 27, 2021. Please refer to our website to find the transition plan template as well as a questionnaire which needs completing to start the MDR CE certification process.
SGS NB1639, and all of its local offices worldwide, looks forward to supporting medical device manufacturers with this enhanced regulatory approach.
For further information, please contact:
Global Medical Devices Certification Manager
t: +41 22 739 98 58
Geofrey De Visscher
Head of Notified Body 1639, Certification
t: +32 3 545 48 60
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