New Medical Device Regulation
The European Regulation (EU) 2017/745 on Medical Devices (MDR) entered into application on 26 May 2021. The MDR introduces a major update of the regulatory framework in the European Union and brings about several changes to the scope of clinical investigations that must be submitted for approval, the submission processes for initial application and substantial modifications, submission dossier contents and safety reporting.
Below you can find the links to several Belgian and European guidelines and documents concerning clinical investigations under the MDR. All questions concerning clinical investigations may be sent per mail to firstname.lastname@example.org.
European legislation and guidelines
• European Regulation (EU) 2017/745 on Medical Devices (MDR)
• The MDCG 2020-5 guidance on clinical evaluation – equivalence
• The MDCG 2020-6 guidance on sufficient clinical evidence for legacy devices.
• The MDCG 2020-7 and 2020-8 guidance on post-market clinical follow up (PMCF) plan and evaluation report.
• The MDCG 2020-10 guidance on safety reporting in clinical investigations of medical devices under the Regulation (EU) 2017/745 (May 2020).
• The Clinical Investigation Summary Safety Report Form for reporting SAEs.
• The MDCG 2020-13 guidance on clinical evaluation assessment report.
• Law of 22 December 2020 concerning medical devices
• Royal Decree May 18, 2021 on the clinical examination of medical devices
• Guideline on Submission Processes of Clinical Investigations according to MDR in Belgium. This document aims at providing guidance for the different submission processes for clinical investigations under the new regulation from a national point of view.
• Clinical Investigations – Guidance on Dossier Content. This document offers a detailed description of each dossier document.
Templates for submission
- Folder structure for initial applications including relevant templates
- Initial application form for clinical investigation under MDR
- Annex A to initial application template (if you have more than one investigational device in your clinical investigation, please complete your application form with this annex)
- Annex B to initial application (if you have more than one comparator in your clinical investigation plan, please complete your application form with this annex)
- Annex C to initial application (if you want to add more sites)
- GSPR form for “general safety and performance requirements and list of standards applied” (document GSPR and list of standards applied).
- List of submitted document for initial application
- List of submitted document for substantial moditication
- Written statement – NEW TEMPLATE for suitability of sites (mandatory use of new template as of October 2023)
- Application form – substantial modifications: please use this application form when submitting one or more substantial modifications to an approved clinical investigation.
Ongoing clinical investigations approved under the European Directive 93/42/ECC
Clinical investigations which have been approved under the European Directive 93/42/ECC, may continue to be conducted following this European Directive, but the reporting of SAE and device incidents must be carried out in accordance with the MDR requirements from 26 May 2021 and onwards as described in section 7 of the “Guideline on submission processes of clinical investigations” (see above).
Substantial modifications to clinical investigations approved in accordance with European Directive 93/42/EEC and the notification of termination of the clinical investigation must follow the procedure relating to European Directive 93/42/CEE, also after 26 May 2021.