International Medical Device Regulators Forum (IMDRF) is a voluntary group of medical device regulators around the world, established in 2011, and builds on the foundational work of the Global Harmonization Task Force (GHTF).
IMDRF accelerates international medical device regulatory harmonization and convergence. The European Commission is one of the important stakeholders. For 2023 the EU undertakes the rotating role of Chair of the IMDRF Management Committee, while the European Commission will act as the Chair on behalf of the EU. The EU’s participation in IMDRF increases international medical device regulatory convergence.
The most recent publication of IMDRF is the guidance concerning the information required in Medical Device Regulatory Review Reports.
Conformity Assessment Bodies (CAB) rely upon these Good Regulatory Review Practices while assessing the technical documentation for medical devices. Medical device manufacturers aiming to comply with MDR will find this document helpful while preparing the submission of technical documentation to the Notified Body. We have provided the link below for you to download the guide, along with other interesting information.
SGS offers MDR Certification on behalf of its MDR Notified Body SGS Fimko Oy (CE 0589) within a wide scope of notification: SGS Fimko Oy Notification Scope.
Check the details of the certification process on our website CE Marking of Medical Devices and get in contact with our Medical Product Certification team in Germany.
We are able to offer the certification service in a timely manner, without long waiting times. You are welcome to contact us by This email address is being protected from spambots. You need JavaScript enabled to view it.. We will explain our MDR certification process at SGS to you and answer your questions.
Your contact
Armin Hudetz
t: +49 89 78 74 75-133
f: +49 89 12 50 40 64-133
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Customer Service Team
t: +49 89 78 74 75-222
f: +49 89 12 50 40 64-100
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Links
Information about our MDR Certification Service
Notification Scope of SGS Fimko Oy:
Information about our Medical Device Services
International Medical Device Regulators Forum (IMDRF)
IMDRF guidance concerning information required in Medical Device Regulatory Review Reports:
SGS Fimko Ltd NB 0598 standard fees list for MDR (EU) 2017/745 EC Certification