EU drug agency to take broader coordinating role in devices and diagnostics in latest proposal

Amendments proposed by the European Commission on 16 December to the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR) have the potential to expand substantially the role of the European Medicines Agency (EMA) in the governance of medical devices and diagnostics. Building on regulation (EU) 2022/123 that became applicable in January to reinforce the EMA's crisis‑preparedness role for medicinal products and devices, the new draft provisions consolidate EMA's secretariat functions for expert panels. They also formalise the agency's support for national authorities in borderline and classification decisions, clinical evaluation and vigilance. 

The new provisions integrate this support into new mechanisms for drug supply interruption monitoring and combined device‑drug studies, nudging selected aspects of the devices framework one step closer to the more centralised pharmaceutical model, while retaining the decentralised notified body structure.

Upgraded coordinated model

The MDR and IVDR confirmed the former EU medical devices directive's decentralised governance architecture centred on national competent authorities and notified bodies. In addition, expert panels were created to provide scientific and clinical advice, but their organisation and resourcing have been an evolving work‑in‑progress.

Regulation (EU) 2022/123 subsequently tasked the EMA with providing the secretariat for these expert panels and with certain crisis‑related functions.

The EMA expanded its role in medtech earlier this year by introducing a new procedure for scientific advice on high-risk medical devices, particularly those that combine drugs and devices. This initiative, together with a pilot programme for orphan medical devices, aimed to align clinical development with regulatory expectations under the MDR and forthcoming EU pharmaceutical reforms.

Despite these advancements, the Commission's evaluation of the MDR and IVDR identified fragmentation of governance structures and limited availability of technical regulatory advice at EU level as contributing to uneven implementation and unpredictability. Stakeholders called for more centralised coordination, particularly for borderline issues, complex clinical evaluations and crisis management.

Expanded EMA role and SME support

A new proposed article 106b (support by the EMA) of the MDR explicitly sets out the agency's functions in connection with medical devices.

The agency will provide scientific, technical and administrative support to national competent authorities on behalf of the Commission, facilitating coordination to ensure uniform application of the regulations across the Union. This support is directed at four areas. The first concerns regulatory status of products and classification matters. The second relates to derogations from conformity assessment procedures in exceptional circumstances. The third covers clinical evaluation and investigation activities. The fourth addresses vigilance and market surveillance, including support to coordinating authorities in multi-country procedures.

The proposed regulation mandates the EMA to establish a dedicated support scheme for small and medium-sized manufacturers of medical devices and diagnostics. This scheme mirrors the agency's existing small and medium-sized enterprises (SME) support programmes in the pharmaceutical field and is expected to include guidance on regulatory pathways, classification queries and interaction with notified bodies.

To enable effective coordination based on real-time data, the EMA would be granted access to Eudamed, the European database on medical devices, and related electronic systems by article 106b(4) MDR.

Expert panel secretariat and advisory remit

The Commission's proposal would replace the existing provisions governing the tasks of the medical device coordination group (MDCG) and the framework for scientific and technical advice.

Under the new structure, the Commission would be empowered to designate expert panels through implementing acts, following consultation with the MDCG. These panels would be responsible for delivering scientific, clinical, technical and regulatory guidance on how the MDR and IVDR should be applied, with their advice available to the Commission, the MDCG, Member States, notified bodies and manufacturers alike. They may be established on a permanent or temporary basis and should comprise individuals with demonstrated, up-to-date expertise in clinical, scientific, technical or regulatory matters relating to medical devices or in vitro diagnostics. Panel composition should reflect the range of regulatory approaches across the EU.

The EMA provides the organisational and administrative support for these panels, consistent with its responsibilities under the regulation (EU) 2022/123.

Notably, under new article 106(7) MDR, expert panels' tasks are broadened beyond their pre‑existing roles in clinical evaluation consultation to include: providing scientific, clinical, technical and regulatory advice to the Commission, MDCG, Member States and notified bodies; contributing to development and maintenance of guidance and common specifications; contributing to standards development; and identifying emerging safety and performance concerns. The Commission may further adapt these tasks via delegated acts.

The legislative initiative therefore institutionalises expert panels as general scientific advisory bodies rather than limiting them to narrower dossier‑specific roles.

Supply interruption and derogations

The proposal dovetails with earlier amendments coming from regulation (EU) 2024/1860, which required manufacturers to inform competent authorities of interruptions or discontinuations of supply for certain devices and mandated the development of a Union‑wide IT tool and a list of devices subject to such obligations.

New MDR provisions allow national authorities, for a limited period and on request, to authorise non‑CE‑marked devices or related diagnostic and therapeutic services   in the interest of public health, patient safety or patient health, and require notification of these authorisations to the Commission, other Member States and expert panels, as well as publication of key information. The proposal further explicitly links new or upgraded derogation procedures to public health emergencies recognised under regulation (EU) 2022/2371 and empowers the Commission, after consulting the MDCG and, where needed, via urgent implementing acts to grant or extend such derogations at Union level.

EMA's central expertise and data access would underpin these EU‑wide derogation decisions, even though the legal decision‑making would still rest formally with the Commission.

Combined studies

A helpful illustration of "pharma‑style" governance is the introduction of formal MDR and IVDR procedures for combined studies involving medicinal products and devices.

For example, performance studies forming part of combined studies and subject to authorisation under article 58 (additional requirements for certain performance studies) of the IVDR could now be carried out in accordance with the Clinical Trials Regulation's article 14c (combined studies) introduced by the (draft) European Biotech Act. Notably, if the sponsor chooses this route, the requirements of article 14c and its implementing or delegated acts would apply in place of the corresponding requirements of the IVDR.

Analogous provisions for clinical investigations involving medical devices as part of combined studies are included in the related Biotech Act proposal, which amends the Clinical Trials Regulation to establish a coordinated assessment procedure for combined studies involving medicinal products, IVDs and medical devices.

Vigilance and market surveillance coordination

EMA's central support is expected to facilitate coherent EU‑wide responses where incidents or non‑compliance have cross‑border implications, and to help integrate AI‑related market surveillance with device vigilance.

Under the draft regulation, EMA is tasked with supporting coordination in vigilance and market surveillance. This includes assistance to the coordinating competent authority for the MDR and IVDR coordinated procedure which involves multi‑Member State evaluations of serious incidents, field safety corrective actions and trends.

The proposal further amends article 93 (market surveillance activities) of the MDR to require Member States to ensure that national competent authorities are provided with adequate and sufficient technical, financial and human resources. Authorities should also have sufficient infrastructure to fulfil their tasks effectively, while a new paragraph mandates cooperation with market surveillance authorities designated under the recently adopted Artificial Intelligence Act for devices that are high‑risk AI systems. 

Osborne Clarke comment

While still at proposal stage and subject to change during the ordinary EU legislative procedure, the draft amendments would, in aggregate, move selected aspects of device and diagnostics governance closer to the EMA‑centred model already seen for medicinal products, particularly for complex, cross‑border or crisis‑related questions.

​If adopted in their current form, manufacturers operating at the interface between medicines and devices (for example, drug‑device combinations, companion diagnostics and advanced therapies incorporating device components) could see more integrated support on classification, combined studies and vigilance, as well as potential efficiencies where procedures are aligned with the Clinical Trials Regulation.

​For device‑only manufacturers, the EMA's proposed support and SME scheme would not replace the decentralised notified‑body model but could, over time, offer an additional point of reference for challenging borderline, clinical and vigilance matters, depending on how the new mechanisms are implemented in practice. These EMA‑centred processes may also gradually bring device and medicinal product regulatory approaches closer together, particularly in areas such as benefit-risk assessment, risk management planning and post‑authorisation evidence generation.

These EMA‑centred processes may also support a gradual convergence of device and medicinal product regulatory cultures, notably around benefit–risk assessment, risk management planning and post‑authorisation evidence generation.