Medical devices and in vitro diagnostic medical devices

Commission proposal for a Regulation of the European Parliament and of the Council amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards simplifying and reducing the burden of the rules on medical devices and in vitro diagnostic medical devices, and amending Regulation (EU) 2022/123 as regards the support of the European Medicines Agency for the expert panels on medical devices and Regulation (EU) 2024/1689 as regards the list of Union harmonisation legislation referred to in its Annex I, COM(2025)1023 final of 16.12.2025; (170 page(s), in English), (46 page(s), in English)

Regulation (EU) 2017/745 on medical devices (MD Regulation) and Regulation (EU) 2017/746 on in vitro diagnostics medical devices (IVD Regulation) establish a new regulatory framework for medical devices and in vitro diagnostic medical devices. Their objectives are a high level of protection of health for patients and users and the smooth functioning of the internal market for these products.

The MD Regulation has been applicable since 26 May 2021. It was notified to the WTO as notification G/TBT/N/EU/71. In March 2023, the European Parliament and the Council adopted a staggered extension of its transition period, ranging from 31 December 2027 for high risk devices to 31 December 2028 for medium and lower risk devices. It was notified to the WTO as notification G/TBT/N/EU/943.

The IVD Regulation has been applicable since 26 May 2022. It was notified to the WTO as notification G/TBT/N/EU/72. In January 2022 and in July 2024, the European Parliament and the Council adopted a staggered extension of its transition periods, ranging from 31 December 2027 for high risk in vitro diagnostics to 31 December 2029 for lower risk in vitro diagnostics. They were notified to the WTO as notification G/TBT/N/EU/845 and G/TBT/N/EU/1044.

Despite considerable progress made over the past years, multiple challenges regarding the implementation of the Regulations on medical devices and in vitro diagnostics, persist. The notified proposal is the immediate follow up of the targeted evaluation of the EU regulatory framework for medical devices conducted by the European Commission in 2024/25. The notified proposal aims to streamline and future-proof the regulatory framework. Its main objective is to simplify rules, reduce the administrative burden on manufacturers and enhance the predictability and cost-efficiency of the certification procedure by notified bodies, while preserving a high level of public health protection and patient safety.

The notified proposal aims to

·        reduce the administrative burden including reporting obligations;

·        enhance the predictability and cost-efficiency of the certification processes of notified bodies;

·        make the conformity assessment requirements more proportionate, especially for low- and medium-risk devices;

·        adapt conformity assessment procedures to the needs of breakthrough technology devices or orphan devices;

·        enable further digitalisation;

·        streamline procedures including those on governance and enhance availability of external expertise for evidence-based decision-making;

·        enable the EU medical device sector to benefit from international cooperation including reliance, where appropriate;

·        enhance coherence of the requirements throughout the Regulations and with other Union legislation.