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.
Request assistance with the MDR certification process through our form below or contact us at [email protected].
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.
The purpose of a structured dialogue prior to lodging a formal MDR application with TÜV SÜD is to clarify the timing, procedural, and regulatory aspects of the application process and forms, and the submission documents.
These structured dialogues are limited to meetings with clients before the application for a conformity assessment and are independent of the assessment. Therefore, and to show the utmost intention of being independent, impartial, and objective, the structured dialogue service shall be ordered independently from the MDR framework agreement.
Expand the tabs below to find out the possible topics, process and how to apply for Structured Dialogue.
Application & Onboarding
Topics of manufacturer
Conformity Assessment Procedure
Existing clients with TÜV SÜD Notified Body
Potential clients:
The most significant requirements in the MDR include:
The MDR applies to an expanded range of medical devices including products that were not previously covered by the MDD and AIMDD. Specific examples of newly covered medical devices include those that do not have a medical intended purpose, such as coloured contact lenses and cosmetic implant devices and materials. Also included in the scope of the MDR are devices designed for the purpose of “prediction and prognosis” of a disease or other health condition.
Device manufacturers are now required to identify at least one person within their organisation who is ultimately responsible for all aspects of compliance with the requirements of the MDR. The organisation must document the specific qualifications of this individual relative to the required tasks. Special relief for some of these provisions may be applicable to small enterprises and start-up entities.
Annex VIII of the MDR details the requirements governing the classification of medical devices. In several instances, the MDR classification requirements are more rigorous than those in the MDD or AIMDD, resulting in the assignment of a higher risk class for some devices and the need to meet more stringent requirements than in the past.
Device manufacturers are now required to conduct clinical investigations to support claims of both safety and performance in a medical device in cases where sufficient clinical evidence is not available. Manufacturers are also required to collect and retain post-market clinical data as part of the ongoing assessment of potential safety risks.
Manufacturers should carefully consider the MDR’s strict requirements on the use of evidence of equivalence in determining whether or not a clinical investigation is required.
The MDR mandates the use of unique device identification (UDI) mechanisms with medical devices. This requirement is intended to support the ability of manufacturers and Authorities to trace specific devices through the supply chain, and to facilitate the prompt and efficient recall of medical devices that have been found to present a safety risk. In addition, the European Databank on Medical Devices (Eudamed) has been expanded to provide more efficient access to information on approved medical devices.
Notified Bodies now need to be involved in the conformity assessment of class I reusable surgical instruments towards the aspects relating to the reuse of the device, in particular cleaning, disinfection, sterilization, maintenance and functional testing and the related instructions for use or the reprocessing.
The MDR mandates increased post-market surveillance (PMS) authority by the Notified Body. Unannounced audits, along with product sample checks and product testing will strengthen the EU’s enforcement regime and help to reduce risks from unsafe devices. Annual safety and performance reporting by device manufacturers is also required in many cases.
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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