Clinical Trials Regulation becomes fully applicable

From today, allclinical trials in the European Union (EU), including ongoing trials that were approved under the previous legal framework, the Clinical Trials Directive (CTD), are governed by the Clinical Trials Regulation (CTR). This marks the end of a three-year transition period, during which more than 5,000 clinical trials were transitioned to the CTR through submission to the Clinical Trials Information System (CTIS), the single-entry point for sponsors and regulators for the submission and assessment of applications for clinical trials in the EU.

Remaining trials that are ongoing after 30 January and that were not moved to the new system may be subject to corrective measures applied by EU Member States. Transition procedures are no longer available and sponsors of ongoing CTD trials are required to submit a new application via CTIS.

CTIS includes a public searchable database for healthcare professionals, patients and the general public to deliver the high level of transparency foreseen by the regulation. The authorisation and oversight of clinical trials is the responsibility of EU/EEA Member States while EMA is responsible for maintaining the CTIS. The European Commission oversees the implementation of the Clinical Trials Regulation. Throughout 2025, the performance and the user experience of CTIS will continue to be improved.

The full implementation of the CTR strengthens Europe as an attractive location for clinical research. The regulation streamlines the processes for the application and supervision ofclinical trials, and their public registration: all clinical trial sponsors use the same system and follow the same procedures to apply for the authorisation of a clinical trial, no matter where they are located and which national competent authority (NCA) or national ethics committee they are dealing with.

Activities related to the CTR are supported by the Accelerating Clinical Trials in the EU (ACT EU) initiative, a collaboration between the Heads of Medicines Agencies (HMA) in the Member States, the European Commission and EMA, which seeks to transform how clinical trials are initiated, designed and run. ACT EU features focus areas that are the basis for the ACT EU multi-annual workplan 2025-2026.

MedTech Europe本周发布信息

The Innovative Health Initiative’s calls for proposals 9 and 10 have launched

The IHI Call 9 is an applicant-driven single-stage call for proposals with five topics, each aligned with one of the five specific objectives of the IHI’s Strategic Research and Innovation Agenda. In November 2024, the IHI held a brokerage event to facilitate networking for this call for proposals; the presented pitches and online platform remain open for networking until the call deadline.

The deadline for call 9 proposals is 29 April 2025.

The IHI Call 10 is a two-stage call for proposals covering diverse topics such as digital labelling of medical technologies,   Per- and Poly-fluoroalkyl substances in the healthcare sector, and enabling and safeguarding innovation in secondary use of health data in the European Health Data Space.

MedTech Europe本周发布信息

Highlights from recent events from the Conference Vetting System team: Webinar success and major conferences

On 21 January 2025, MedTech Europe hosted its fourth highly successful webinar, drawing over 375 attendees. The event was filled with engaging questions. During the training session, we explained the reviewed criteria, introduced the new CVS/e4ethics 2.0 platform, and showcased the new features that went live in January 2025. These exciting updates include the ability to follow events, an improved search function for organisations in the submission form, and the option to attach files in the messaging system. The deck of the presentation is already available on this webpage, with the recording to follow. If you missed the webinar and would like to stay informed, please register on this link.

Additionally, CVS had the honour of participating in the Professional Convention Management Association (PCMA) Convening Leaders conference in Houston from 11-15 January. We had the opportunity to connect with Professional Congress Organizers (PCOs), explain the revised criteria and discuss compliance in focus groups.

Furthermore, CVS was featured at the ACForum(Associations & Conference Forum) during the industry Compliance session on 17 January and presented the updates of CVS/e4ethics at the Compliance session of the IPCAA (International Pharmaceutical Congress Advisory Association) conference in Warsaw on 29-30 January. These events provided us with a platform to share our insights and further engage with Medical Associations, Healthcare Organizations, PCOs, and MedTech Europe and EFPIA members.

MedTech Europe本周发布信息

Nathalie Virag takes up role as Chair of the Governing Board of the Innovative Health Initiative

MedTech Europe is proud to announce that Nathalie Virag, Chair of the MedTech Europe Research and Innovation Committee and Senior Director and General Manager at Medtronic, has begun her mandate as Chair of theInnovative Health Initiative (IHI) Governing Board in December 2024, marking the first time a MedTech Europe representative assumes this position.

“I am honoured to take on the role of Chair of the Governing Board of the Innovative Health Initiative. Together, we have an incredible opportunity to shape the future of health innovation and deliver on the IHI’s mission to improve the lives of patients across Europe. I look forward to collaborating with our partners to drive impactful projects in this important partnership,”Nathalie said.

The IHI Governing Board, comprised of representatives from the European Commission and the IHI industry partners, is the main decision-making body of the IHI and is responsible for ensuring it achieves its objectives.

MedTech Europe本周发布信息

Key update on SARS-CoV-2 IVD (EU) classification

The European Commission’sIn Vitro Diagnostics expert panel has concluded that SARS-CoV-2 no longer presents a life-threatening risk with significant mortality for the general European population. This decision will impact the classification of SARS-CoV-2 tests under the In Vitro Diagnostic Medical Devices Regulation 2017/746/EU (IVDR).

While an update to theMDCG 2020-16 classification guidance may yet take several months, this expert opinion and the European Commission’s communication of 29 January 2025 provide welcome clarity for the industry, helping manufacturers navigate regulatory requirements with greater certainty.

MedTech Europe本周发布信息

Joint industry statement on the draft Article 102 Guidelines

MedTech Europe, together with leading European and international industry associations, has issued a joint statement on the European Commission’s draft Guidelines for the application ofArticle 102 of the Treaty on the Functioning of the European Union (TFEU). The statement provides feedback on how the guidelines can better support legal certainty, effective enforcement, and Europe’s competitiveness.

The co-signatories welcome the Commission’s efforts to offer guidance on exclusionary abuses but highlight areas where further clarification is needed. Ensuring a clear, predictable framework will help businesses assess compliance while fostering innovation and fair competition in the EU.

BfArm本周发布信息

Field Corrective Actions

MHRA本周发布信息

Guidance Software and artificial intelligence (AI) as a medical device

3 February 2025

Added link to guidance on digital mental health technology: qualification and classification.

SWISS MEDIC本周发布信息

Surveillance of the use of medical devices for anti-wrinkle injections

The cantonal therapeutic product authorities and the Office for Health of Liechtenstein, in collaboration with Swissmedic, inspected the use of fillers in 82 clinics, medical practices, and cosmetic studios.

SWISS MEDIC本周发布信息

Refined interpretation of the Mutual Recognition Agreement (MRA) between Canada and Switzerland

In 2000 the Mutual Recognition Agreement (MRA) between Canada and Switzerland on Medicinal Products Drug GMP Compliance Certification (Sectoral Annex on GMP) became operational.

As of January 31, 2025, Health Canada and Swissmedic agreed to expand the existing approach to include both the recognition of GMP extra-jurisdictional inspection outcomes as well as active pharmaceutical ingredient and stable medicinal products derived from human blood or human plasma in the operational scope. Furthermore, they agreed on the information sharing and reliance processes related to Health Canada’s on-site evaluation and Swissmedic’s pre-approval inspection.

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