The Enterprise Europe Network informs:
03/08/2023
Medical devices play a crucial role in saving human lives by providing innovative medical solutions for the diagnosis, prevention, monitoring, treatment or alleviation of diseases. In April 2017, the European Parliament and Council adopted Regulation (EU) 2017/745 and Regulation (EU) 2017/746 to strengthen the regulatory framework for medical devices and in vitro diagnostic medical devices.
The European Commission proposed to allow more time for the certification of medical devices. The new transition periods (2024-2027) are based on the risk class of the medical devices.
Now the Council of the European Union has adopted the Commission's proposal to give notified bodies and manufacturers more time to certify medical devices, thereby mitigating the risk of supply shortages. This follows the European Parliament's positive vote last month. The legislative proposal provides for a longer transition period to adapt to new provisions in the Medical Devices Regulation. It aims to ensure that patients who rely on them continue to have access to medical devices.
Core contents of the regulations:
- For medical devices for which a certificate or declaration of conformity was issued before May 26, 2021, the period for transition to the new rules will be extended from May 26, 2024, to Dec. 31, 2027, for higher-risk devices, and to Dec. 31, 2028, for medium- and lower-risk devices. The extension will be conditional, allowing more time only for devices that are safe and for which manufacturers have already taken steps toward transitioning to the medical device regulations.
- The proposal also introduces a transition period until May 26, 2026, for Class III implantable custom devices, giving manufacturers more time to obtain certification from a Notified Body. Again, the transition period is contingent on the manufacturer having applied for a conformity assessment for medical devices of this type before May 26, 2024.
- The Commission is also proposing to remove the "sell-by" period currently specified in the Medical Devices Regulation and the In Vitro Diagnostics Regulation. This sell-through period corresponds to the end date after which products that have already been placed on the market and are still commercially available should be withdrawn from the market. Eliminating this sell-by date will ensure that safe and important medical devices that have already been placed on the market continue to be available to health care systems and the patients who rely on them.
- The proposal does not change the current safety and performance requirements set forth in the Medical Devices Regulation. It only amends the transitional provisions to allow manufacturers more time to transition from the previously applicable requirements to the new requirements of the regulation.
For more information, see here . https://youth.europa.eu/discovereu_dehttps://www.bayreuth.ihk.de/system/vst/4214258?id=369929&terminId=633694https://ec.europa.eu/commission/presscorner/detail/en/QANDA_21_4614
Source: European Commission
https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/12497-revision-of-EU-legislation-on-food-contact-materials_enhttps://germany.representation.ec.europa.eu/news/kreislaufwirtschaft-neue-eu-vorschriften-ermoglichen-verwendung-von-recyceltem-kunststoff-2022-09-15_de
Accessibility
Language
