Both the Medical Devices Regulation (EU) 2017/745 (MDR) and the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) aim to provide “a robust, transparent, predictable and sustainable regulatory framework that ensures a high level of safety and health while supporting innovation”. However, despite more than six years of implementation, the European and Swiss medical technology industry say that the IVDR and MDR have not achieved their intended objectives. Importantly, they say that there are structural issues in the Regulations that cannot be overcome by their implementation.
In their open letter to European Commissioner for Health & Food Safety, Stella Kyriakides, the representative associations have called for comprehensive structural reform of the European regulatory framework for medical technologies. They say that it is urgently needed to address systemic issues encountered by patients and health systems alike in accessing medical technology throughout Europe.
Systemic regulatory issues
Among the systemic issues identified by the representative organisations are that the regulatory framework is unpredictable, complex, slow and costly. They claim that this:
- Impacts access by European patients and health systems to medical technologies, both those already on the market and future innovations
- Slows the pace of innovation in Europe, with medical technology innovations available in other regions not available in Europe, and
- Causes certain products to no longer be available for medical care in Europe
The representative organisations have called for:
- An efficient CE marking system: A more efficient and resource-effective CE marking system would improve predictability, reduce the administrative burden, and flexibly adapt to external changes. Examples of measures suggested include:
- Predictable and transparent deadlines and costs for all regulatory processes
- Removing the limited validity of certificates, and
- Bringing the EU into the Medical Device Single Audit Program (MDSAP) programme
- Support for innovation: The inclusion of an innovation principle to quickly connect the latest medical technologies to European patients and health systems through dedicated assessment pathways and early dialogues with developers.
- An accountable governance structure: The establishment of a single, dedicated structure to oversee and manage the regulatory system, including the designation and oversight of Notified Bodies, with the authority to make system-level decisions.
MedTech Europe and the other signatories to the letter are highly critical in their assessment of the current EU regulatory position. However, the representative organisations have indicated their willingness to work with Commissioner Kyriakides and the European Commission to deliver the desired structural reform. A response from Commissioner Kyriakides and the European Commission is awaited.
This adds to mounting pressure from the medical technology industry following the publication in June 2023 of a similarly critical White Paper by German medical technology associations on the future development of the MDR and IVDR.
For more information, contact a member of our Product Regulation & Consumer team.
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