In recent months, news about the Medical Device Regulation has accumulated. Last week, positive news emerged as European legislators yielded to industry pressure, agreeing to extend transition periods. This means you can keep your medical device, and with the new deadlines, there’s renewed hope for timely documentation updates. Continue reading to learn what you need to know and how we can assist with your medical device.
Starting Point
The new EU Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) present significant regulatory challenges. Self-registration of substance-based medical devices as class I is no longer an option, as they now belong to higher classes. All existing products on the market must undergo re-certification under the new MDR following a more complex conformity assessment procedure. Furthermore, there are insufficient notified bodies (NB) to perform mandatory certification. The new MDR requirements and NB bottlenecks jeopardize the availability of many medical devices, leading to requests for extended transition periods. The European Parliament has approved the draft legislation, allowing companies in limbo to breathe easier.
Legal Amendments
The MDR transition delay grants more time for shifting from old rules to new requirements, while safety and performance requirements remain the same.
The amendment includes these changes:
The validity of MDD certificates or declarations of conformity issued since 26 May 2021 will be extended by prolonged transition periods as follows:
- For class III custom-made implantable devices: 26 May 2026
- For class III and class IIb implantable devices: 31 December 2027
- For class I, class II, and class IIb non-implantable devices: 31 December 2028, provided the manufacturer submits a formal application for conformity assessment to a notified body by 26 May 2024 and signs a written agreement with the notified body by 26 September 2024.
The amendment also removes the ‘sell-off’ date, initially preventing the sale of products already on the market and within the supply chain beyond May 2025.
Manufacturer Implications
Don’t let the extended deadlines discourage you from marketing your medical device in Europe. The extension allows manufacturers, particularly those who were hesitant, to update technical documentation, gather relevant data, and potentially perform clinical studies to obtain the MDR CE mark. It’s not too late!
How a&r Can Help
The new regulations are more complex, but we’re here to help. At a&r, everything is under one roof: strategic consulting, conceptual planning, conducting studies, and compiling documents. We generally propose this approach:
- Regulatory strategy: Our regulatory team develops a customized concept for your product.
- Clinical studies: If necessary, our clinical research team plans and conducts clinical trials.
- Documentation compilation: Clinical planning integrates into the concept, and we create the technical dossier based on it.
If you’ve already completed this process, we’re happy to assist with regular updates. Contact us today!
