Since the Medical Devices Regulation (MDR) and the In-vitro Medical Device Regulation (IVDR) came into full force, several individuals and associations have raised concerns regarding inefficiencies, excessive bureaucracy, and the impact on patient access to critical medical devices. In response, a variety of proposals to reform MDR and IVDR have emerged, with some calling for urgent reforms and others advocating for a more thoughtful, long-term evaluation. Different perspectives of key players in the medical technology industry show common concerns and propose solutions to ensure MDR’s and IVDR’s effectiveness.
The urgent need for reform: MEP Liese’s proposal
On 18 October 2024, He acknowledges that while the regulation improved safety standards after incidents like the PIP breast implant scandal, it has also introduced significant inefficiencies. Lengthy certification processes, high costs, and mandatory recertifications have created barriers to access, particularly for orphan devices and niche markets such as paediatric cardiology. Liese proposes several reforms aimed at streamlining the regulatory system while maintaining high safety standards. These include:
- Simplifying requirements for low-risk devices
- Creating expedited pathways for innovative products
- Introducing tailored rules for orphan devices
- Strengthening Notified Body capacity
- Revising compliance role qualifications
- Extending transitional periods
These measures, according to Liese, are critical for improving access to essential medical devices and maintaining Europe’s competitiveness in the global medical technology market.
HMA Core Group’s call for immediate action
Similarly, the for Medical Devices echoes the need for urgent action to address the challenges in implementing the and IVDR. While the group supports the regulations’ ultimate goal of safeguarding patient safety and fostering innovation, it highlights significant obstacles. The HMA Core Group does not offer specific proposals but it calls for legally sound and immediate solutions to prevent disruptions in medical device supply.
COCIR’s focus on immediate and structural measures to reform MDR and IVDR
COCIR is an organisation representing manufacturers in the medical imaging, radiation therapy, and digital health sectors. It advocates for immediate corrective actions, and at the same time calls for structural reforms. Measures that are recommended to enhance MDR implementation, among others include:
- Harmonised interpretation of requirements via standardised technical documentation.
- Wider adoption of electronic instruction for use.
- Structured dialogues during conformity assessments.
- Reassessment of certificates validity
To address systemic issues, COCIR advocates for structural reform of the regulatory and policy framework for medical devices in Europe. The development of a single governance structure with specific competences for medical devices would help achieving several objectives, like:
- Adopting Harmonised Standards.
- Ensuring availability of medical technologies for patients and healthcare systems.
- Supporting efficiency and predictability of the regulatory system.
MedTech Europe’s strategic reform recommendations
On 14 October 2024, MedTech Europe, along with 39 national associations, sent an open letter to EU Commissioner Stella Kyriakides urging immediate reforms to both the MDR and IVDR to ensure medical device availability and the competitiveness of the sector. MedTech Europe emphasised the urgency of reversing the exodus of innovation from Europe and preventing the discontinuation of critical medical technologies. In particular, the letter outlines three key priorities:
- Legislative reforms by 2025 to ensure that the regulatory framework is efficient, innovation-friendly, and well-governed.
- Urgent bridging measures to reduce certification time and costs, enable faster technology assessments, and establish an accelerated pathway for breakthrough innovations.
- Ongoing implementation improvements such as streamlining technical documentation requirements and promoting the adoption of electronic instructions for use.
MedTech Europe’s proposals focus on creating a more agile regulatory environment to support the medical technology sector’s growth while ensuring patient safety.
Biomedical Alliance in Europe’s cautious approach
The Biomedical Alliance in Europe stresses the importance of a careful, science-based evaluation of the MDR and IVDR. It warns against rushing reforms that may fail to address the underlying issues or may have unintended consequences on patient safety and device availability. The Alliance advocates for a detailed, thoughtful review of the regulations and urges policymakers to avoid implementing short-term fixes without a proper diagnosis. Their reform of MDR and IVDR proposal includes:
- Supporting the ongoing review by the European Commission.
- Avoiding short-term legislative measures without careful diagnosis and impact assessment of the regulatory system’s shortcomings.
- Basing revisions on scientific principles, ensuring clear and predictable requirements for clinical evidence.
- Addressing IVDR separately to reflect the distinct needs and complexities of the diagnostic sector.
- Increasing the use of clinical and scientific expertise to develop common specifications and enable evidence-based regulatory decisions.
- Implementing targeted short-term measures to:
- Reduce certification costs.
- Mitigate shortages of medical devices, particularly orphan and paediatric devices.
The future of European competitiveness: Report by Mario Draghi
The European Commission’s recent publication of Mario Draghi’s report on EU competitiveness highlights Europe’s need to regain a leading role in innovation. While Draghi’s focus is on pharmaceuticals, he identifies an “innovation and competitive deficit” also in industries like medical devices compared to other parts of the globe.
This deficit, however, according to Draghi’s report, is not irreversible. The two general paths that he prescribes for the EU medical devices industry to regain its pioneering character are:
- Simplification of the regulatory regime: In the context of medical devices, this indirectly means the simplification of the MDR. Nonetheless, no specific details are provided for such simplification or deregulation.
- Incorporation of new technologies: Draghi highlights that technologies such as AI could drive significant productivity and performance improvements in the medical devices sector, potentially restoring Europe’s leadership in the industry.
Joint paper initiative at the Council of the European Union
On 28 November 2024, Croatia, Finland, France, Germany, Ireland, Luxembourg, Romania, Malta, and Slovenia submitted a joint paper to the Council of the EU. This paper outlines necessary reforms for MDR and IVDR to improve their implementation and address existing challenges. Key priorities include:
- Reduction of administrative burdens
- Centralisation of system management to EMA
- Streamlined and easily predictable certification procedures
- Addressing specific needs for targeted patient populations
- Special pathways for innovations
These reforms aim to improve regulatory efficiency, foster innovation, and ensure patient safety while maintaining global competitiveness.
For more updates on developments and amendments of MDR and IVDR, contact MDlaw.
References
- COCIR (2024). COCIR Statement on urgent measures needed to ensure the availability of medical technologies in Europe. Retrieved 22/11/2024
- COCIR (2024). COCIR position on the future governance framework for the medical technologies sector. Retrieved 22/11/2024
- Council of the European Union (2024, 28 November). AOB for the meeting of EPSCO (Health) of 3 December 2024: Necessary reforms in the Medical Device and In vitro Diagnostic Medical Device Regulations: priorities / main points – Information from Croatia, Finland, France, Germany, Ireland, Luxembourg, Malta, Romania and Slovenia. Retrieved 02/01/2025.
- European Commission (2024). The future of European competitiveness: In-depth analysis and recommendations. Retrieved 22/11/2024
- German Ministry of Health (2024). Background paper on the Medical Devices Regulation. Retrieved 22/11/2024
- Health Minister’s Association (HMA) (2022). Statement on the effective application of the EU regulatory system for medical devices. Retrieved 22/11/2024
- MedTech Europe (2024). Urgent need for action on the medical technology regulations to ensure devices availability and competitiveness of the sector. Retrieved 22/11/2024
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