MedTech Europe Publishes IVD-Specific Recommendations for the MDR/IVDR Revision
MedTech Europe has published a new position paper outlining its recommendations for the ongoing revision of the EU Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR). The document, “An Improved Regulatory Framework: What Do Europe’s Diagnostics Need?”, focuses specifically on the needs of the in vitro diagnostics (IVD) sector and complements the association’s broader position on the European Commission’s proposed legislative changes.
According to MedTech Europe, the European Commission’s proposal represents a positive step towards a more risk-proportionate regulatory framework while maintaining existing safety and performance requirements. The paper identifies several elements that the association supports and others that it believes should be further strengthened during the legislative process.
Focus on Proportionate Regulation
The paper highlights that most IVDs are classified as low- to medium-risk devices under the IVDR, while only a limited number fall into the highest-risk categories. MedTech Europe argues that future regulatory requirements should better reflect the specific risk profile of IVDs and the way risks are controlled through performance evaluation, quality management systems, and professional interpretation of test results.
The association supports the Commission’s proposal to introduce more risk-based oversight, including technical documentation sampling focused on higher-risk devices rather than applying the same level of scrutiny across the sector.
Measures Intended to Support Innovation
A key theme throughout the paper is the need to maintain Europe’s competitiveness in the diagnostics sector.
MedTech Europe welcomes several simplification measures proposed by the Commission, including reduced certification burdens, streamlined regulatory processes, broader recognition of clinical evidence sources, and the removal of certain duplicative reporting requirements. According to the association, these measures could help support innovation capacity, particularly for small and medium-sized enterprises (SMEs), which represent a significant proportion of the European IVD sector.
Concerns Regarding Health Institution Tests
The position paper also addresses the proposed expansion of the circumstances under which health institutions may use their own tests.
MedTech Europe supports regulatory simplification for health institutions but recommends maintaining the principle that CE-marked devices should remain the preferred option when suitable alternatives are available. The association argues that this approach would help preserve a consistent regulatory framework across the diagnostics sector.
Orphan IVD Definition Under Discussion
Another area highlighted in the paper concerns the proposed definition of orphan IVDs.
MedTech Europe notes that the threshold proposed in the legislative revision may exclude certain niche diagnostic tests used in areas such as rare diseases, transplantation, transfusion medicine, and companion diagnostics. The association therefore recommends aligning the orphan IVD definition with the existing EU definition used for rare diseases.
Additional Areas Identified by Industry
The paper also supports several other aspects of the Commission’s proposal, including:
Open-ended certificate validity combined with periodic risk-based reviews;
Risk-based conformity assessment sampling;
Streamlined change control procedures;
Digitalisation of regulatory processes;
Digital labelling;
International regulatory cooperation.
In addition, MedTech Europe calls for further consideration of topics such as artificial intelligence within the IVDR framework, cybersecurity reporting requirements, the treatment of health institution tests, and clarification of requirements related to specimen collection procedures in performance studies.
What This Means for Manufacturers
Although the MDR/IVDR revision remains under discussion, the paper provides insight into the priorities currently being advocated by the European diagnostics industry.
Manufacturers of IVDs may wish to monitor developments related to conformity assessment requirements, evidence generation pathways, orphan diagnostics, digital regulatory processes, and the future relationship between CE-marked devices and health institution-developed tests, as these topics are likely to remain central to the legislative negotiations.
