EU: Extension to Medical Devices Regulation
Medical devices play a crucial role in saving lives by providing innovative medical solutions for the diagnosis, prevention, monitoring, treatment or alleviation of diseases. In April 2017, the European Parliament and the Council of the EU adopted Regulation (EU) 2017/745 on medical devices (“MDR”) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (“IVDD”) to strengthen the regulatory framework for medical devices and in vitro diagnostic medical devices.
The MDR applies since 26 May 2021. It includes a transition period until 26 May 2024 to allow medical device manufacturers have time to adapt their products to the new regulations and undergo the conformity procedure necessary to place medical devices on the market. However, due to a large number of conformity assessments for medical devices, it is far from possible to complete the necessary conformity procedure for all medical devices. To reduce the risk of bottlenecks, the EU Commission therefore adopted a proposal on 6 January 2023 to allow more time for the certification of medical devices.
The proposal aims to introduce a longer transition period for the changeover to the new regulations in the MDR. This shall give medical devices manufacturers more time to obtain MDR-compliant certificates. The new transition periods are based on the risk class of the medical devices and are intended to ensure uninterrupted patient access to medical devices, according to the EU Commission’s press release. It is also intended to allow medical devices that were placed on the market under previous regulatory framework, and which are still available to remain on the market (i.e. the sell-by period is to be abolished). The proposal is not intended to change the existing safety and performance requirements laid down in the MDR. It is only intended to change the transitional provisions to give manufacturers more time to transition from the previously applicable rules to the new requirements.
The time periods by which the transitional periods are extended under the proposal depend on the type of medical device. For medical devices for which a certificate or a declaration of conformity was issued before 26 May 2021, the transition period to the new rules is extended from 26 May 2024 to 31 December 2027 for higher risk devices (e.g. pacemakers and hip implants) and to 31 December 2028 for medium and lower risk devices (e.g. syringes or reusable surgical instruments). The proposal also introduces a transition period until 26 May 2026 for implantable custom-made devices in Class III, giving manufacturers more time to obtain certification by a Notified Body. In this case, too, the transition period is dependent on the manufacturer having applied for a conformity assessment for medical devices of this type before 26 May 2024.
In addition, the EU Commission proposes to delete the “sell-by period” currently specified in the MDR and the IVDD. This sell-by date corresponds to the end date after which products that have been placed on the market and are still available in commerce should be withdrawn from the market. The removal of this phase-out period will ensure that safe and important medical devices that have already been placed on the market continue to be available to healthcare systems and the patients who rely on them.
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