EU set to upgrade medtech and diagnostics regulations

The European Union is on the brink of transformative regulatory changes in the medical devices and diagnostics sectors in 2025, affecting businesses active throughout the supply chain from manufacturing and production to import and distribution.

The EU is looking to foster innovation through a comprehensive review of existing regulations, streamlined procedures for drug-device combinations and enhanced clinical study coordination. Some of the proposed changes also aim to address growing concern in the industry regarding the fitness of current medtech rules and processes. Health technology assessments, electronic instructions for use and measures to address supply issues will modernise the landscape, while expected legislative initiatives promise to shape the future of medtech laws.

Review of the EU's MDR and IVDR

The European Commission has initiated a targeted evaluation of the EU Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) earlier than the legally required deadline due to significant challenges in transitioning to the MDR and IVDR from the former standards. This aims to assess the effectiveness, efficiency, relevance, coherence and "added value" for the EU of the regulations, ensuring they meet current and emerging needs while supporting innovation.

The evaluation closed on 21 March and has gathered feedback from a broad range of stakeholders through public consultations, targeted activities and workshops. After collecting this input, the Commission will now analyse the data to identify areas for improvement, potential simplification and alignment with other EU policies. The findings will be adopted in the fourth quarter this year, guiding future amendments to enhance regulatory coherence and address any identified gaps and inefficiencies.

EMA's growing medtech involvement

In February, the European Medicines Agency (EMA) has established a regular procedure for scientific advice on certain high-risk technologies. This initiative allows manufacturers of class III devices and class IIb active devices intended to administer or remove medicines to request scientific advice on their clinical development strategy and proposals for clinical investigation. The process aims to streamline the development and approval of drug-device combination products, an area that will significantly be impacted by the ongoing reform of the EU pharmaceutical legislation.  

Until the end of 2025, manufacturers of high-risk products intended for rare conditions can apply for advice through the ongoing EMA pilot programme for orphan medical devices. Applications are also open for notified bodies. For selected proposals, the EMA will provide support in obtaining orphan status and clinical evaluation or clinical development strategy advice. The pilot initiative is set to facilitate the introduction of new orphan devices to the EU market and ensure the continued availability of legacy products under the MDR. During the year, four applications are meant to be selected for initial testing.

Cross-border and combined studies

Until 30 June, the Commission is welcoming applications from medtech businesses that wish to participate in a pioneering pilot for coordinated assessments of clinical investigations and performance studies across multiple countries. This initiative allows study sponsors to submit a single application for cross-border assessments, fostering harmonised interactions with participating Member States.

To join the pilot assessment, sponsors must provide the regulatory documentation required by the MDR and IVDR, as outlined in guidelines issued by the Medical Device Coordination Group (MDCG). The MDCG templates and documents should be utilised until the European database on medical devices (Eudamed) platform is ready for studies.

The "Combine" project strategy, endorsed by Member States in late 2024, marks another significant advancement in the coordination of clinical trials and medical device studies, now fully subject to the EU's harmonised clinical trials regulation.

Combine is an EU initiative designed to simplify the regulatory environment for combined studies involving medicinal products, devices and diagnostics. Highlighted in Mario Draghi's recent report as a key driver for EU competitiveness in clinical research, it seeks to make the EU more appealing for such studies by addressing challenges and promoting collaboration among authorities, ethics committees and stakeholders, ultimately supporting the availability of innovative treatments for patients.

Businesses can expect significant advancements this year and in 2026. The programme will concentrate on coordinated assessments for combined study applications, piloting new procedures, and integrating IT systems like CTIS (the Clinical Trials Information System) and Eudamed. Efforts will also focus on aligning regulatory requirements, optimising serious adverse event reporting, and clarifying the use of medical devices in clinical trials.

Health technology assessment

On 24 January, the Health Technology Assessment (HTA) Regulation (EU) 2021/2282 came into effect, marking a new era of collaboration among EU Member States on health technologies, specifically medical devices and in vitro diagnostics.

From this date, the HTA Regulation mandates joint clinical assessments for high-risk medical devices classified as class IIb or III under the MDR and diagnostics classified as class D under the IVDR. These compulsory assessments ensure evaluations are accurate, high-quality, and grounded in the best scientific evidence available. A coordination group established under the EU regulation is tasked with overseeing these assessments and consultations, providing crucial guidance on the data and evidence required from clinical studies. The group also oversees the assessments of certain medicinal products ensuring compliance with the newly applicable HTA Regulation.

Moreover, the HTA Regulation allows medtech developers to request that a joint scientific consultation on their device occurs in parallel with the consultation with an expert panel designated under the MDR. To facilitate this, the recent implementing Regulation (EU) 2025/117, effective from 24 January, outlines procedural rules for these joint scientific consultations.

Electronic instructions for use

The Commission recently published a draft amendment updating the existing regulation (EU) 2021/2226, which lays down rules for the application of the MDR to electronic instructions for use (eIFU). Public consultation on the draft text ran from 21 February to 21 March this year.

If adopted, this regulation will expand the scope of eIFU to include all medical devices intended for professional users, enhancing healthcare professionals' access to faster, digitalised and more efficient solutions. Other highlights include the requirement for eIFU to be available via a persistently accessible URL, registered in the UDI (unique device identification) database upon Eudamed implementation, and the stipulation that patient instructions for implantable devices cannot be provided electronically. Products that are not yet fully compliant with the MDR or IVDR would continue to follow regulation (EU) 207/2012, until the end of a proposed transition period set to end on 31 December 2028.  

The draft amendments aim to modernise the provision of instructions for use, ensuring that providers and healthcare institutions can access critical information swiftly and reliably.

Supply issues

On 22 January, the MDCG reviewed its guidance on a manufacturer interruption form to signal  the interruption or discontinuation of supply of certain medical devices and diagnostics, following the recent tightening of EU rules on health tech supply issues. This form, along with a device identification table, aims to optimise the process of informing relevant authorities about those issues. Concurrently, the Commission released an updated Q&A document clarifying the obligation to inform in case of interruption or discontinuation of supply, as introduced by the recent regulation (EU) 2024/1860.

These measures are designed to ensure that supply disruptions are promptly communicated, allowing for timely interventions to mitigate potential impacts on patient care and healthcare services.

Ongoing surveys and legislative initiatives

In 2025, several pivotal surveys and legislative projects are poised to redefine medical device regulation within the EU. These efforts are designed to promote regulatory clarity, simplify processes, and alleviate the regulatory burden on medtech businesses, all while upholding rigorous safety and efficacy standards.

The ongoing study monitoring the availability of medical devices in the EU market will continue until December 2025. This EU-mandated analysis aims to gather comprehensive data on availability, thereby informing regulatory decisions and shaping policy development.

Additionally, the Commission intends to adopt an implementing decision by the second quarter of this year that will impact MDR and IVDR-mandated expert panels. These panels provide essential scientific, technical, and clinical advice to enforce the MDR and IVDR. The proposed decision seeks to enhance their administrative management and establish a specialised panel for orphan and paediatric devices. Other initiatives aim to address well-established medtech technologies, with plans to expand their list to exempt them from some legal requirements and reducing administrative burden. There are further proposals to reclassify some of them, with distinct regulations expected between the third and fourth quarters of 2025.

Upcoming EU sectorial measures will also focus on enhancing the uniform application of requirements for notified bodies. The Commission has announced the adoption of a new regulation by the end of the year, aiming to standardise these requirements across the board.

Osborne Clarke comment

Recent and forthcoming EU regulatory changes in the medical devices and diagnostics sectors are redefining the industry's operations across the medtech supply chain in 2025.

With streamlined clinical procedures and improved study coordination, the EU is committed to encouraging innovation and addressing industry challenges. Coordinated assessments for cross-border clinical investigations and performance studies will enable smoother regulatory interactions. It is also hopes that enhanced electronic instructions for use and measures to tackle supply issues will boost operational efficiency and ensure timely access to vital information. Upcoming legislative initiatives appear to be striving for efficiency and simplification.

However, these measures may lack impact if no decisive action is taken following the ongoing MDR and IVDR targeted evaluations, echoing the ambitious recommendations proposed by the European Parliament last year. The current plans and reforms are substantial, yet the rapidly evolving medical device industry is eager for simplified compliance strategies, reduced administrative burdens and accelerated development pathways for cutting-edge and orphan medical technologies. In these pivotal times, companies are encouraged to stay informed to seize new opportunities and maintain their competitive edge in the dynamic EU market.