EU-commissioned study finds MDR, IVDR have dampened medical device investment

More than half of medical device companies in the EU have reduced their product portfolios to cope with the complexities of the EU Medical Device Regulation (MDR) and EU In Vitro Diagnostic Regulation (IVDR), while 17% have stopped producing devices entirely due to high certification costs and administrative burden.

Those were the findings of a study conducted by consultancy EY for the European Commission. The goal of the study, conducted between 2023 and 2024, was to identify the key benefits and challenges associated with the regulatory governance structure of the MDR and the IVDR. It also examined the regulations’ impact on innovation and patient safety. The study was published by the EU Publications Office in early 2026.

The study utilized an online survey with 470 respondents, conducted 41 targeted interviews, held four workshops, facilitated three stakeholder consultation workshops, and performed a benchmarking exercise. In the online survey, most replies came from Germany, which accounted for 19% of the total responses. This was followed by Italy with 10%, the Netherlands and France both with 9%, Spain at 7%, and Belgium at 6%.

The study found that “economic operators appear to have altered their product offering following the introduction of the Regulations. This has been suggested in previous studies and was confirmed in the current survey, in which 57% of respondents noted to have reduced their device portfolios, while 24% noted to have ceased production of devices for the EU market as a result of the introduction of the MDR and IVDR.”

The European Parliament adopted the MDR and IVDR in 2017, implementing MDR in May 2021 and IVDR in May 2022. However, both regulations have encountered challenges since their implementation, resulting in several transition periods and delays.

The findings indicated that larger firms are more likely to have reduced their product offerings. Nearly seven out of ten (69%) of the surveyed large companies reported that they had cut their existing device portfolios in the EU market due to new regulations. In contrast, only 13% of the small and medium-sized enterprises (SMEs) that were consulted reported a reduction in their portfolios.

Stakeholders were also asked to address the extent to which the current regulatory framework supports innovation and competitiveness in the next 5-10 years. In response, stakeholders expressed skepticism about the adaptability of the MDR and the IVDR to foster technological innovation in the sector.

The survey revealed that only 11% of respondents believe the MDR/IVDR will significantly support technological innovation in the next 5-10 years. Similarly, 12% viewed the regulations as somewhat adaptable to facilitate innovation during this period. In contrast, 34% of respondents feel that the MDR/IVDR will not support technological innovation in the sector over the next 5-10 years.

These criticisms of the MDR and IVDR are surfacing at the same time as the European Commission is proposing targeted reforms to simplify the rules for medical devices. On 16 December, the Commission proposed a new regulation to streamline the regulatory pathway for medical devices (RELATED: EU Commission proposes major reforms to MDR, Regulatory Focus, 18 December 2025).

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EU-commissioned study finds MDR, IVDR have dampened medical device investment

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