How to Achieve EU Market Access for Medical Devices
How to Achieve EU Market Access for Medical Devices
Published in the Official Journal of the European Union in April 2017, the EU MDR (Regulation (EU) 2017/745) was developed to reflect the significant progress in medical device technologies that had taken place since the implementation of the EU’s initial framework in the 1990s, and to harmonize the regulatory review and approval process across all EU Member States.
The requirements of the MDR became applicable to all medical devices sold in the EU as of 26 May 2021. Currently, the implementation of certain MDR provisions will be extended until as late as December 2028 for medical devices that were previously approved under the Medical Devices Directive 93/42/EEC (MDD) and Active Implantable Medical Devices Directive 90/385/EEC (AIMDD).
On 15 March 2023, the Regulation (EU) 2023/607 was formalised, which provides medical device manufacturers more time to certify medical devices to mitigate the risk of shortages. The amended regulation introduces a longer transition period to adapt to new rules under the MDR for products already on the market under the MDD/AIMDD.
Refer to the MDR FAQs for more information on the key elements of new MDR transition timelines.
It’s important to note that the extension of transition period to the new rules is subjected to certain conditions. More time will only be granted for products that are safe and for which manufacturers have already taken steps regarding the transition to MDR:
TÜV SÜD continues to strongly encourage manufacturers to act now, despite the new deadlines. The procedure of the EU MDR is known to be complex and sometimes requires longer processing times. TÜV SÜD has, at an early stage and steadily, built up capacities and is in constant close exchange with manufacturers on the changeover. However, manufacturers must also become active in the new situation and work at full speed on the planning, to avoid any delays at the end of the transition timelines.
The EU is one of the largest markets for medical devices in the world. With approximately €150 billion in sales in 2022, the EU comprises nearly 30% of the global market, second only to the United States (41%). Total medical device sales in the EU are expected to exceed €170 billion by 2027, driven in part by technological advancements such as artificial intelligence (AI) and remote monitoring capabilities. This makes the EU an important market for all medical device manufacturers, from major corporations to innovative start-up entities.
TÜV SÜD Product Service was among the world's first notified bodies to receive designation as a Notified Body for the MDR by the Central Authority of the Länder for Health Protection with regard to Medicinal Products and Medical Devices (ZLG).
With more than 750 medical device professionals in more than 30 locations worldwide, we are one of the largest EU Notified Body globally authorized to provide certification services under the EU’s MDR.
a. MDR Request for Service Registration
Request assistance with the MDR certification process through our form below or contact us at [email protected].
b. Conformity Assessment Procedure & FAQs
Manufacturers need to apply for an applicable conformity assessment procedure based on their product classification. A step by step guide is available on MDR Application Procedure. You can also find out more information about the EU’s MDR by visiting our Frequently Asked Questions page.
Read on to find out about the key changes and challenges of certification.
The most significant requirements in the MDR include:
The complexity in developing new and advance medical devices, combined with the rigorous requirements embodied in the EU’s MDR, are likely to make the regulatory approval process challenging for many device manufacturers. Even manufacturers of medical devices that were previously approved under the MDD or the AIMDD are not exempt from the MDRs requirements, and legacy devices still being sold on the market must be recertified in accordance with the MDR’s provisions.
Further, with the exception of Class I devices, an EU Notified Body must be involved in the approval and certification of all medical devices that fall within the scope of the MDR. Given the expanded scope of medical devices that require Notified Body review and approval, delays in the review and approval process should be anticipated. Device manufacturers are advised to consult with a Notified Body early in the product development process to plan the steps necessary to achieve timely and efficient MDR review and certification. Advanced preparation and early action are key.
Assessment of the MDR Technical Documentation within the MDR conformity assessment procedure
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On May 5th 2017, the European commission has published a new regulation for medical devices.
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