Euro Roundup: Swissdamed registration module goes live ahead of mandatory use

The Swiss Agency for Therapeutic Products (Swissmedic) has started accepting voluntary registrations of medical devices on swissdamed.

Swissmedic began operating swissdamed, the national medical devices database, one year ago. Yet, like its counterpart in the European Union, swissdamed was incomplete when it launched and Swissmedic is introducing new modules gradually. The Actors module, which allows economic operators to register and update their details, has been live since August 2024 but other features were unavailable initially.

This week, the UDI Devices module went live. The module supports the registration of certain medical devices, in vitro diagnostics and systems and procedure packs. Swissmedic said the module “adds a key functionality to the database that will increase transparency in Switzerland’s medical devices market.”

Currently, the registration of devices in swissdamed is voluntary. Swissmedic plans to make registration of medical devices placed on the Swiss market mandatory on 1 July 2026 and implement a transitional period that will extend to the end of next year. The transitional period will apply to devices, systems and procedure packs that were placed on the market before 1 July 2026.

There are limits on which devices can benefit from the transitional period. The period will not apply to devices subject to a reporting obligation for serious incidents, field safety corrective actions or trends. For those devices, the 1 July 2026 requirement for mandatory registration is a hard deadline.

The agency published a user guide for the UDI Devices module late last week. The document outlines who is able to register devices in swissdamed and explains the registration process. Seeking equivalence with the EU framework, Swissmedic has aligned the design of swissdamed with Eudamed. The design is intended to allow companies to transfer data between the EU and Swiss databases.

There is no interface between the databases, but companies can upload XML files in Eudamed formats to swissdamed. Swissmedic plans to make further upload methods such as machine-to-machine transfers available in the future. The agency will charge a one-time fee for registering devices in swissdamed but is yet to provide further details.

Press Release, Swissmedic Handbook

Planning October launch, MHRA posts guide to Route B substantial modification pilot

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published guidance on plans to streamline the assessment of some substantial modifications to clinical trials.

Recent updates to clinical trials legislation in the UK established two types of substantial modifications to studies. Route B applies to modifications “where there are no new significant safety concerns with any of the investigational medicinal products, as far as the sponsor is aware having made reasonable enquiries.” Changes also to meet at least one other criterion, such as only affecting certain parts of the protocol.

Companies that apply for Route B modifications will automatically receive approval within 14 days unless the licensing authority intervenes. The regulations that create Route B will come into force in April 2026, but MHRA is encouraging companies to take part in a pilot project that is scheduled to start in October 2025 and finish at the end of March 2026.

While Route B applications will not receive automatic approvals during the pilot, MHRA has committed to authorizing the changes or moving to a full assessment within 14 days. The agency’s commitment to the timeline may result in a staged rollout if the pilot program is oversubscribed. MHRA has created a form for companies that want to register to participate in the pilot.

As well as gaining early access to 14-day approvals, participants in the pilot will be able to give feedback and gain familiarity with the Route B eligibility criteria before the new regulations come into effect.

MHRA Guidance

EMA starts consultation into ICH guideline for extractable and leachable impurities

The European Medicines Agency (EMA) is seeking feedback on International Council for Harmonisation (ICH) guidelines about extractable and leachable impurities.

ICH Q3E presents a framework and process for the assessment and control of extractable and leachable impurities. The guideline follows the risk-management principles described in ICH Q9 and is intended to complement existing ICH documents about impurities, including ICH Q3C on elemental impurities and ICH M7 on mutagenic impurities.

The document features sections about risk assessment and control, chemical testing and assessment, analytic evaluation thresholds and safety assessments. ICH has also drafted appendices that provide more details and examples for specific topics and a separate document about supporting documentation for class 3 leachable monographs.

Class 3 leachables are compounds with relatively low toxic potential. The guideline proposes eliminating the need for further safety qualification if Class 3 leachables are found below a daily exposure threshold. ICH is recommending that Class 1 leachables, which include mutagens covered by ICH M7, are avoided. The guideline proposes limiting exposure to Class 2 leachables.

The Class 3 document provides a detailed look at six leachables. The monographs include summaries of the safety of the leachables, acceptable levels of exposure and their roles in pharma manufacturing.

EMA is accepting feedback on the guideline until 18 December.

EMA Consultation

Swissmedic shares position paper on parenterals without an intended medical purpose

Swissmedic has published a position paper on parenteral products that fall between its classifications for medical and cosmetic products.

The agency has tracked a rise in imports of products that are given parenterally, for example by injection or infusion, but lack an intended medical purpose. Rather, the products are used for cosmetic or wellness purposes. The intended purpose of the products means they are not authorized as medicinal products. Yet, the route of administration means the products are not classified as cosmetics.

To date, Swiss authorities have made decisions about the products on a case-by-case basis. Seeking to provide legal certainty, Swissmedic has decided to apply therapeutic products legislation to parenterals without an intended medical purpose.

“Before these products can be lawfully placed on the market in Switzerland, they must therefore either possess a marketing authorization that is valid in Switzerland or have successfully completed the relevant conformity assessment procedure in accordance with the Swiss Medical Devices Ordinance,” Swissmedic said. “Otherwise, the above-mentioned products may not be marketed in Switzerland.”

Swissmedic’s position reflects the “risk potential” associated with the route of administration and mode of action of parenteral products.

Swissmedic Notice

Other News:

Swissmedic said its drug authorization times are “catching up with EMA.” A benchmarking study found throughput times for new applications with new active substances were stable in 2024. The agency said submission and approval gaps between Swissmedic and EMA narrowed. The approval gap between Swissmedic and its US counterpart narrowed, too, but the submission gap widened. Swissmedic Notice

MHRA has shared guidance on switching between GLP-1 medicines. Updating existing guidance on the diabetes and weight-loss drugs, MHRA said patients should speak to a healthcare professional before switching from one medicine to another, including between brands containing the same type of GLP-1. The advice reflects differences in the strengths, uses and indications of the drugs. MHRA Guidance

Swissmedic and swissethics have updated their position paper on decentralized clinical trials. Version 3.2 of the document reflects ICH-GCP E6 (R3), updated international good clinical practice guidelines that the ICH adopted in January. The ICH guideline covers decentralized trials. Swissmedic Notice

Euro Roundup: Swissdamed registration module goes live ahead of mandatory use

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