Meeting the Requirements of the EU Medical Device Regulation (MDR)

How to Achieve EU Market Access for Medical Devices

How to Achieve EU Market Access for Medical Devices

WHAT IS EUROPEAN UNION (EU) MDR

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).

UPDATED TIMELINE OF EU MDR TRANSITION TIMELINE

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:

  • This means that the application has to be submitted latest by 26 May 2024 and the contractual agreement with TÜV SÜD has to be concluded latest by 26 September 2024.

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.

Request for a MDR service registration today

IMPORTANCE OF THE EU MEDICAL DEVICE MARKET

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.

HOW TÜV SÜD CAN HELP MANUFACTURERS ACHIEVE MDR COMPLIANCE

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].

Request for a MDR service registration today

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.

c. Structured Dialogue

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.

 

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