EU Medical Devices Regulations Information Center
Here you will find some important documents to guide you in an application for certification against the new Medical Devices Regulation and In Vitro Diagnostic Medical Device Regulation.
References
- Certification Process and Medical Devices Contact List Map
- Price and Fee Structure for Medical Devices and In Vitro Diagnostic Devices
- Medical Device Questionnaire
- Notified Body Managers' Declaration of Interest
- SGS MDR Transition Plan Template
- Transition Guidance for SGS Customers
- SGS Post Market Clinical Follow Plan Template
External Documents
- Implementation Model for Medical Devices Regulation
- Implementation for Medical Devices Regulation (Focus on Manufacturer’s obligations)
- Implementation Model for In-Vitro Diagnostic Medical Devices Regulation
- MDR IVDR Infographic
- Factsheet for Manufacturers of Medical Devices
- Factsheet for Manufacturers of In Vitro Diagnostic Medical Devices
- Factsheet - Medical Devices and in vitro Diagnostic Medical Devices (For Authorised Representatives, Importers and Distributors)
- Factsheet on Medical Devices and in vitro Diagnostic Medical Devices (For non-EU/EEA States)
- Transition Timelines from the Directives to the Regulations
- EUDAMED - Actor Registration Factsheet
- Guidance for Actor Registration Module in EUDAMED (V1 -Sept. 2020)
Get in touch
SGS Belgium NV
Intercity Business Park, Generaal De Wittelaan 19 - A5
Mechelen, 2800
Belgium
Mechelen, 2800
Belgium