Mutual recognition of Medical devices between the EU and Switzerland en route for a return?
On 26 May 2021, the mutual recognition agreement between the EU and Switzerland, which included medical devices, ceased to apply.
Among the practical consequences of this step was that Swiss manufacturers were no longer able to claim mutual recognition of their medical devices on the EU market. Manufacturers of medical devices of Swiss origin were, thereafter, required to fulfil the same obligations as other third country manufacturers before placing their devices on the EU market.
Team-NB publishes position paper on Combinatorial Use of Reagent Devices
Team NB published a new position paper on Combinatorial Use of Reagent Devices. The position paper is intended to clarify notified body expectations concerning demonstration of safety and performance of reagents used with other equipment.
The position paper covers reagents that are categorized as “closed systems” (defined …
EU Critical Medicines Act Nudges Closer As Parliament Adopts Position
The European Parliament Plenary has overwhelmingly supported the Institution’s proposed Critical Medicines Act.
Among the provisions that MEPs supported were the creation of industrial “strategic projects'” located in the EU. These are intended to create, modernise, and improve manufacturing capacity in the EU. The proposal also seeks to see both the EU and the competent national authorities in individual EU Member States prioritise …
Irish Framework Agreements in principle on supply and pricing of medicinal products
The Irish Minister of Health has announced the conclusion of two Framework Agreements in principle with the Irish Pharmaceutical Healthcare Association (IPHA) and Medicines for Ireland (MFI) on the pricing and supply of medicinal products. The Agreements, which will apply until 31 December 2029, are intended to strengthen security of supply of medicinal products and reduce the risk of shortages of medicinal products to patients.
The purpose of the Framework Agreement with IPHA is to enhance the current pricing and reimbursement
New ISO Standards for surgery published
Commission Implementing Decision (EU) 2026/193, adopted on 28 January 2026, introduces new EN ISO standards for use in assessment of the conformity of medical devices with the Medical Devices Regulation (MDR). Compliance with the provisions of EN ISO standards that have been published in the Official Journal of the European Union as part of Commission Implementing Decisions gives rise to
HTA Coordination Group publishes its 2025 Annual Report
In its 2025 Annual Report the Health Technology Assessment (HTA) confirmed that, in 2025, four joint scientific consultations were completed.
The Group also commenced 13 joint clinical assessments on new
EMA and FDA set common principles for AI in medicine development
The European Medicines Agency (EMA) and the US FDA have jointly developed ten principles for good Artificial Intelligence (AI) practice in life cycle management for medicinal products.
The purpose of these principles is to permit AI used in the development of medicinal products to be
MDCG Guidance on Breakthrough Devices under the MDR and the IVDR
The Medical Device Coordination Group (MDCG) has published its Guidance, MDCG 2025-9, on Breakthrough Devices within the Medical Devices Regulation (MDR) and the in vitro diagnostics Medical Devices Regulation (IVDR).
Neither the MDR nor the IVDR include a definition of what constitutes a Breakthrough Device. MDCG 2026-9, however,
MDCG Guidance on post-market surveillance of Medical Devices and In Vitro Diagnostic Medical Devices
In its last publication of 2025, MDCG 2025-10, the Medical Device Coordination Group (MDCG) provides guidance to manufacturers concerning the post-market surveillance (PMS) obligations imposed by the Medical Devices Regulation (MDR) and the in vitro diagnostics Medical Devices Regulation (IVDR) and the appropriate steps to ensure that these are fulfilled.
The Guidance recalls
Revised MDCG Position paper concerning timeline for implementation of Master UDI-DI for contact lenses and spectacle frames
The Medical Device Coordination Group (MDCG) has published its revised position paper, MDCG 2025-7 Rev. 1, concerning timelines of implementation of Master UDI-DI in relation to contact lenses and spectacle frames, spectacle lenses, and ready-to-wear reading spectacles. The purpose of the revision is to clarify the dates by which implementation of the Master UDI-DI and use of the UDI/Device registration module of EUDAMED become obligatory for these devices. The dates are:
European Parliament Committee revised and amplified version of the draft Critical Medicines Act
On 15 December 2025, the European Parliament’s public health Committee, SANT, adopted its proposed version of the draft Critical Medicines Act. The version amplifies, and in some aspects diverges from, the text of the Act proposed by the European Commission.
Of particular interest, and in some circles concern, was the proposed expansion in the definition of “Medicinal Product of Common Interest” provided
EMDN Helpdesk
The European Medical Device Nomenclature (EMDN) Helpdesk is now live. The EMDN is the nomenclature of use by manufacturers when registering their medical devices in the EUDAMED database.
The Helpdesk is intended to provide users with information concerning the
Timetable for EMA advice to medical device manufacturers
The European Medicines Agency (EMA) has published its timetable concerning the Agency’s procedure for providing advice to medical device manufacturers. This advice procedure, which is based on Article 54 of the Medical Devices Regulation (MDR), is intended to
A Master UDI-DI becomes obligatory for spectacle frames and lenses
Commission Delegated Regulation (EU) 2025/1920, which was published on 23 September 2025, has introduced an obligation to assign a Master UDI-DI to spectacle frames, spectacle lenses and ready-to-wear reading spectacles. A Master UDI-DI must be assigned to frames sharing the same design parameters, to lenses with the same combination of design parameters, and to ready-to-wear reading
New draft Guidance on Trend Reporting
The Medical Device Coordination Group (MDCG) has endorsed a new draft Q&A document on trend reporting under the EU Medical Device Regulation (MDR) and the in vitro diagnostics Regulations (IVDR) (Trend Reporting Q&A (MDCG 2025-X)).
Article 88 of the MDR and Article 83 of the IVDR provide a framework through which manufacturers should report statistically significant increases in the frequency or severity
EMA develops a Concept Paper on the development of guidance concerning use of external controls for evidence generation in regulatory decision making
The European Medicines Agency (EMA) has published a Concept Paper on the Development of a Reflection Paper on the Use of External Controls for Evidence Generation in Regulatory Decision Making (Concept paper).
The Concept Paper recalls the current lack of specific regulatory guidance concerning the use of external controls to support regulatory decision making
Updated Guidelines on the Variations Regulation - but not until January 2026
Following adoption of Regulation (EC) No 1234/2008 (the Variations Regulation), which applied from January 2010, the European Commission published related Guidelines in 2013. The Guidelines have not subsequently been updated. As a result, the revisions to the Variations Regulation that occurred in 2021 and 2024 are not reflected in the existing version of the Guidelines.
The new Variation Guidelines that were recently published reflect the 2024 amendment of the Variations Regulation
ICH proposal for Guidelines for Extractables and Leachables
The ICH proposal for Guidelines for Extractables and Leachables has been published on the European Medicines Agency (EMA) website. The purpose of the draft Guideline is to provide a global framework for managing leachables in pharmaceutical products.
European Commission sets new clinical trial targets for the EU
The European Commission, the Heads of Medicines Agencies (HMA), and the EMA have jointly developed two new targets for clinical trials, to monitor progress against the ambition of making the EU a more attractive destination for clinical research and to improve timely access to innovative medicines for patients. The aim is that, in the coming five years:
Swissmedic reduces review times for generic medicinal products
Swissmedic has shortening the procedural time limits for applications for new authorisation of generic medicinal products. This change is part of the continuous development of the procedure under Art. 13 TPA