Amendment Regulation (EU) 2023/607 now legally binding: Extended opportunity for manufacturers to recertify medical devices according to MDR!
On March 20, 2023, the European Union published Regulation (EU) 2023/607, which extends the transitional periods for placing on the market or putting into service of medical devices and abolishes the sell-off period. These measures are intended to help counteract bottlenecks in the recertification process. In the following, we take a closer look at the key aspects of the amendment regulation and its implications.
The importance of medical devices for modern medicine is undisputed. They save lives, improve patients' quality of life and enable breakthrough advances in the diagnosis, prevention, monitoring, treatment and alleviation of disease.
However, since the introduction of the new Medical Devices Regulation in 2017, manufacturers have faced significant regulatory challenges. The stricter requirements, limited capacity of the Notified Bodies, and the enormously increased documentation effort represent an immense hurdle for the required recertification until May 2024.
For this reason, the long-awaited adjustment of Regulation (EU) 2017/745 (MDR) has finally been implemented at the European level through Regulation (EU) 2023/607. The latter is based on the proposals of the Employment, Social Policy, Health and Consumer Affairs Council (EPSCO) of December 9, 2022, which we have already reported on."
Extended transitional periods and abolition of sell-off period for medical devices now in force!
Regulation (EU) 2023/607 brings two significant changes that provide a much-needed opportunity for manufacturers of medical devices to ensure that recertification under MDR can still be carried out on time and patients can continue to have unrestricted access to essential medical devices.
- Extended transitional periodsRegulation (EU) 2023/607 extends the transitional periods for medical devices of different risk classes to give manufacturers more time to adapt to the new requirements of the MDR. The deadline extensions depend on the classification of the products and the specific requirements that must be fulfilled according to the MDR.These are as follows:·Class III devices and Class IIb implantable devices (excluding sutures, braces, dental fillings, dental braces, dental crowns, screws, wedges, dental or bone plates, wires, pins, clamps and connectors) may be placed on the market or put into service until December 31, 2027.· Other Class IIb devices, Class IIa devices, and Class I devices placed on the market in a sterile condition or having a measuring function may be placed on the market or put into service until December 31, 2028.
· Custom-made medical devices (Class III) must be adapted by May 2026.
- Abolishment of the sell-off period
The EU Commission has abolished the sell-off period established in the regulations. This means that safe and essential medical devices that are already on the market and meet the applicable requirements can continue to be available to healthcare systems and patients without being withdrawn from circulation. Just like with the adjustment of the transitional periods, possible supply shortages are to be prevented and it is ensured that patients continue to have access to important medical devices.
Manufacturers of medical devices must not rest on these measures!
Although the extended transitional periods give manufacturers more time, they should not remain idle but actively take steps to transition to Regulation (EU) 2017/745 (MDR).
The new Regulation (EU) 2023/607 explicitly calls for the establishment of a quality management system in accordance with Article 10(9) of the MDR by the deadline of May 26, 2024. Additionally, a conformity assessment application must be submitted to the Notified Body by this deadline. Furthermore, manufacturers must conclude a written agreement with a Notified Body for certification according to Annex VII Section 4.3 Subsection 2 of the MDR by September 26, 2024, at the latest. It is important to apply for the contract before the MDD certificate expires and to include all products for which the extended transitional periods are to be claimed. The basis of the contract is the availability of the technical documentation in accordance with the MDR requirements.
At TentaConsult Pharma & Med, we understand the challenges that transitioning to the MDR presents for manufacturers of medical devices and recognize the importance of a fast and smooth implementation of the new requirements. As a reliable and competent partner, we support you in implementing the necessary processes in quality management and in processing the technical documentation. With our comprehensive expertise in the field of MDR and our tailored approach, we ensure efficient and individual implementation and help you achieve MDR compliance as quickly as possible, thus ensuring the marketability of your medical devices.
Don't wait any longer and rely on our support to make your medical devices future-proof.
Contact us today!