Because medical devices such as medical gloves, surgical masks, intensive care equipment and other medical equipment play a crucial role within the context of the COVID-19 pandemic, on 24 April 2020, the application date of various provisions of the European Regulation (Regulation 2017/745) on medical devices was postponed until 26 May 2021.
The date of application of the Medical Device Regulation, scheduled for 26 May 2020, has been postponed until 26 May 2021. This will give manufacturers, authorised representatives, notified bodies, distributors and importers of medical devices extra time to comply with the regulation.
This decision has no impact on the European In Vitro Diagnostic Medical Devices Regulation (Regulation 2017/746). The date of application of this European regulation remains 26 May 2022.
Changes from 26 May 2021
- The European Directive for active implantable medical devices (Directive 90/385/EEC) and the European Directive for medical devices (Directive 93/42/EEC) will not be repealed until 26 May 2021.
- Manufacturers of class I medical devices must comply with the European Medical Device Regulation from 26 May 2021.
- Class I medical devices without a CE certificate and that can make use of the transition period (Article 120.3)) must have a declaration of conformity before 26 May 2021.
- Medical devices with a CE certificate issued before 26 May 2021 can use the transition period.
- Medical devices must have a UDI (Unique Device Identifier) from 26 May 2021.
- Clinical investigations with medical devices and active implantable medical devices must only comply with the European Medical Device Regulation from 26 May 2021. Directives 93/42/EEC and 90/385/EEC remain in effect until that date.
The deferral of the date of application has no effect on provisions that do not have a direct link to the date of 26 May 2021.
- For medical devices that make use of the transition period (Art. 120.3)), the deadline for placing them on the market will be 27 May 2024. For these medical devices, the deadline for making them available on the market or putting them into service remains 27 May 2025.
- Deadlines for applying the UDI carrier to the medical device, label and higher packaging levels are unchanged. The following deadlines will continue to apply:
- For reusable medical devices which require the UDI carrier to be applied to the medical device:
- 26 May 2023 for class III and implantable medical devices;
- 26 May 2025 for class IIa and IIb medical devices;
- 26 May 2027 for class I medical devices.
- For all other medical devices:
- 26 May 2021 for class III and implantable medical devices;
- 26 May 2023 for class IIa and IIb medical devices;
- 26 May 2025 for class I medical devices.
Medical devices that comply with the European regulation can still be placed on the market under this regulation. For Belgian manufacturers and authorised representatives, a notification to the FAMHP is required for class I medical devices.