On 6 February 2025, EU Member States announced the launch of a new pilot scheme for coordinated assessment of clinical investigations of medical devices (CI) and performance studies for in vitro diagnostic (IVD) medical devices (PS). Supported by the European Commission, the pilot allows sponsors to submit a single CI or PS application for review across multiple Member States, rather than each Member State conducting independent standalone reviews. The pilot scheme aims to make the application process for multi-national CI and PS more efficient and to reduce the duplication of activities by both the sponsor and competent authorities. As this has been a major cause of delays and complications in conducting CIs, this pilot will be welcomed by industry.
Background
Certain CI and PS require prior authorisation from the competent authority of each Member State in which the study will be conducted. Currently, an individual application must be submitted to each Member State. This leads to inefficiencies, with each Member State conducting its own standalone assessment and Sponsors needing to separately respond to any requests for information from each Member State. It can also lead to inconsistent outcomes as Member States may reach different conclusions on whether the study is compliant with applicable requirements.
Articles 78 of Regulation (EU) 2017/745 (MDR) and 74 of Regulation (EU) 2017/746 (IVDR) provide for coordinated reviews of applications for multi-national CI and PS. Those articles set out a detailed process for the conduct of such reviews, with applications submitted and coordinated through the Eudamed system. This process is analogous to the coordinated review system for medicines clinical trials, which is already operational under the EU Clinical Trials Regulation 2014/536. However, the procedure under the MDR and IVDR is not yet operational.
Member States have the option to voluntarily apply the procedure. As the relevant module of Eudamed is not yet operational, Member States have agreed to operate the pilot scheme outside the statutory basis for coordinated reviews. Further, the Commission has indicated that it will use the operation of the pilot scheme to help its development of the relevant Eudamed module that will ultimately be used for coordinated reviews under the MDR and IVDR.
Who can participate?
The European Commission has stated that the current call for participants extends only to sponsors of CI for medical devices, with the call for IVD PS opening at a later stage.
To be eligible, the proposed CI (or PS, once operational) must be multi-national and involve at least two participating Member States who have agreed to join the coordinated assessment pilot. So far, 19 EU Member States have expressed interest (including the major markets), as well as one additional EEA state (Norway).
For general medical devices under MDR, the investigational device must be in one of the following categories:
- class III
- class IIa invasive devices
- class IIb invasive devices
For PS of IVDs under IVDR, the study must fall into one of the following categories:
- an interventional clinical PS where the test results may influence patient management decisions and/or may be used to guide treatment
- PS where the conduct of the study involves additional invasive procedures or other risks for the subjects of the studies
- PS involving companion diagnostics
How can sponsors apply to enter the pilot scheme?
CI sponsors interested in participating in the pilot scheme must complete an expression of interest form and submit this to the Commission via email by 30 June 2025.
Expressions of interests will be reviewed on a rolling basis by MDCG Clinical Investigation and Evaluation Working Group members. Reviews will be based on eligibility criteria, and the potential impact of the proposed CI or PS on public health.
What will the coordinated assessment involve?
The question-and-answer document released alongside the Commission’s announcement clarifies that the assessment of applications within the pilot scheme will comprise two steps:
(i) sponsors selected to participate in the pilot will initially submit a single application electronically via a system operated by the Commission, which will be assessed through the coordinated procedure
(ii) following completion of the coordinated review, the sponsor must submit an application to each participating Member State, who will perform the assessment (based on the coordinated review) under its national procedures and grant an authorisation
Sponsors will also separately need to apply for ethical review in each Member State in which they intend to conduct the CI or PS in line with national requirements.
The coordinated reviews will be conducted in accordance with the procedure and timelines set out in Articles 78 of MDR and 74 of the IVDR. Each Member State will perform its own assessment of the application. However, the process is streamlined by a coordinating Member State leading the process and preparing a single draft assessment report. The other Member States have the opportunity to comment on the draft assessment report. The process also places limitations on the opportunities for Member States to ask questions of the sponsor.
The sponsor can nominate a preferred coordinating Member State. Member States will agree between them which Member State will act as the coordinating Member State, and if they cannot reach agreement, it will be the Member State nominated by the sponsor. Currently, only six countries have expressed an interest in acting as a coordinating Member State within the pilot scheme (Austria, Belgium, France, Ireland, Poland and Sweden).
As Articles 78 of MDR and 74 of IVDR are not yet applicable, the outcome of the coordinated assessment is not legally binding on participating Member States in the pilot scheme. However, although the sponsor will still need to submit an application to each individual Member State concerned so each can issue a national authorisation, it is intended that the assessment of the national application will be expedited and each participating Member State will rely on the conclusions from the coordinated review.