Good news for medical device industry: The European Commission has approved a proposal that will give you more time for the certification of your products and thus provide a significant relief. It is also hoped that this will reduce the risk of shortages.
What are the most important changes?
The transition period to the new rules applies to medical devices with a certificate or declaration of conformity issued before 26 May 2021.
This means in detail:
- For custom-made implantable devices of class III: until 26 May 2026.
- For medium and lower risk devices: until 31 December 2028. This includes other class IIb devices, class IIa devices and class ls, lm, lr devices.
- For higher risk devices: until 31 December 2027. This includes class III devices and class IIb implantable devices. Excluded from this are: Wedges, plates, wires, pins, clips, connectors Sutures, brackets, dental fillings, braces, dental crowns and screws.
Breathe a sigh of relief - only conditionally
The above-mentioned extensions are subject to certain conditions. In concrete terms, this means that the extension of the deadline only applies if the manufacturers have already taken steps to convert their products to MDR. In this case, an application for conformity assessment must be submitted by 26 May 2024 at the latest and accepted by the Notified Body by 26 September 2024 at the latest.
The extension of the deadline ensures that, in the interest of patient safety, any bottlenecks with regard to medical devices will not occur and that a reliable supply of medical devices can continue to be guaranteed.
Due to the complexity of the EU Medical Devices Regulation, there is still an urgent need for action if you are a manufacturer and need to convert to MDR.
Get in touch with us. We will be happy to assist you on the subject of MDR.
More information on the topic of MDR is also available on our DQS product page. Here you will find price lists, starter kits and many answers to your questions.
Furthermore, we offer a webinar series on the topic of Medical Device Regulation in cooperation with our partner DGQ. We train you to become an MDR expert in three tailor-made blocks with recommendations for action from the perspective of a Notified Body, which will support you in successfully implementing the requirements in your company.
For German speaking manufacturers register now at:
Webinarreihe zur Medical Device Regulation (MDR) in Kooperation mit der DQS-Med - Deutsche Gesellschaft für Qualität (dgq.de)
