The European Commission has published Guidelines to provide organizations and businesses with greater flexibility in updating and changing marketing approvals. The European Medicines Agency (EMA) and national regulators both collaborated with the commission for the development of new lifecycle management measures. The study emphasized the importance of adopting a risk-based and simplified approach to handling changes more efficiently and effectively.
The recommendations outline updates, including super-grouping and annual reporting for submitting Type IA variations. According to the Commission, a single notice may be used by a marketing authorization holder to submit multiple minor type IA modifications for a similar marketing authorization. This also applies to one or more minor modifications of type IA that are made across multiple marketing authorizations granted in the same Member State.
During the annual update process, no urgent notification is required without approval from the relevant authorities. In a single submission, type IA minor changes for several marketing authorizations are gathered under super-grouping. Businesses with four sets of minor differences in the guidelines may select this option. Furthermore, the variation regulation has changed the manufacturing of biological products and removed the default type II designation for quality-related changes.
The new risk-based approach suggests modifications in manufacturing procedures, quality control tests, and starting materials. EMA will release new and updated procedural instructions by the end of 2025 to assist authorization holders. To address specific regulatory issues, MedTech Europe has joined forces with 35 national organizations and urged the European Commission to address these issues by the end of 2025 or the start of 2026. These modifications aim to strengthen the regulatory framework while improving cost-effectiveness in a straightforward and seamless manner.
The anticipated legislative improvements were acknowledged by MedTech Europe, but they believe that immediate action is required. In an open letter, the organization called for delays in the re-certification for certain items, as well as pilot projects for regulatory pathways covering pediatric, orphan, and innovative technologies. MedTech Europe stated that the European Union (EU) could eliminate repetition of vigilance review to report the scope of modifications, set maximum assessment timelines, and promote earlier stakeholder discussions.
The organization also emphasized that while oversight bodies play an important supervisory role, notified bodies remain essential and will continue to be a cornerstone of the EU regulatory framework. According to the EMA’s five-year plan, two-thirds of clinical studies should start enrolling patients within 200 calendar days of the application date. The studies must recruit patients within 3 months of regulatory clearance or site selection to achieve the goal of decreasing trial initiation periods from 250 days to 150 days. This progress aligns with the Accelerating Clinical Trials in the EU (ACT EU) initiative, which aims to improve trial efficiency across the region.  Â
Additional concerns have been raised regarding the Critical Medicines Act (CMA), particularly in the European Parliament committee discussions, where questions of national responsibility and integrity were highlighted. Moreover, three trade associations recommended expanding the use of electronic instructions for use (eIFU) to cover certain medical devices used directly by consumers. This expansion would ensure that users receive early guidance on device operation, improving safety, comfort, and routine use.
Reference: Taylor N. Euro Roundup: Commission acts to streamline lifecycle management of medicines. Regulatory Affairs Professionals Society (RAPS). Published on September 25, 2025. Accessed on September 29, 2025. Euro Roundup: Commission acts to streamline lifecycle management of medicines | RAPS
