Not all is well in the state of MDR: AESGP releases White Paper on MDR Regulatory Framework

Brussels, 22 April 2024 – New AESGP White Paper highlights challenges faced in implementing the Medical Devices Regulation (MDR) and proposes targeted reforms to enhance the regulatory framework. By building upon existing provisions, the White Paper aims to foster a regulatory framework that guarantees transparency, predictability, efficiency and legal certainty while maintaining a high level of health and safety for people who rely on self-care medical devices.

Since its inception in May 2017 and full implementation in May 2021, the Medical Devices Regulation (MDR) has faced hurdles in achieving its intended objectives. After nearly seven years of implementing the requirements and rules provided for in the MDR, it has become evident that certain goals are beyond accomplishment.

More than 24,000 certificates were issued under the previous legal framework of the Directives and need to be transitioned to the MDR. At the end of October 2023, around 17,800 MDR applications were lodged and around 5,600 MDR certificates were issued.[1] The slow progress towards MDR transition as reflected in those figures has led to concerns over potential bottlenecks and risks of shortages of products available on the market.

The current regulatory framework under the MDR is characterized by unpredictability, opacity, and resource-intensive processes, posing significant challenges for businesses, particularly small and medium-sized enterprises. This environment not only hampers innovation but also impedes rapid and cost-effective market access for medical devices, ultimately impacting patient access and healthcare professional tools.

Recommendations for a robust, transparent, predictable and sustainable regulatory framework for medical devices

In response to these challenges, AESGP developed a series of recommendations aimed at improving and optimizing the existing regulatory system. Our approach, outlined in our white paper, focuses on enhancing current provisions of the MDR rather than advocating for a complete overhaul of the regulatory framework.

  • Targeted Reforms: review validity of certificates; define timelines for conformity assessment; include cost predictability; public registry of decisions on classification disputes; improvement of the Helsinki procedure; allow evidence from previous assessments; integrate single audit program.
  • Streamlined Governance: MDCG endorsement by consensus without abstentions; coordinate actions of MDCG and CAMD; create a working group on drug-device combination products; consistent application and interpretation of MDCG guidance.


Proposed measures seek to enhance transparency, predictability, and legal certainty within the MDR. AESGP is committed to working with relevant stakeholders and authorities at the EU level to address structural challenges in the MDR implementation.


[1] See Notified Bodies Survey on certifications and applications (MDR/IVDR), 11 March 2024 (revised version).


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