EMA publishes Data Quality Framework for Real World Data
The Manual on borderline and classification under Regulations (EU) 2017/745 and 2017/746 v5 has recently been updated. The revised Manual includes details concerning the classification of a number of products
Phase 2 COMBINE programme launched
Following the success of the first phase of the COMBINE coordinated assessment programme, which permitted the assessment of combined studies through the Clinical Trials Information System (CTIS), the European Commission and EU Member States
A new draft of IEC 62304 has been created
A draft of Edition 2 of IEC 62304 has been produced. IEC 62304 Medical device software — Software life cycle processes establishes life cycle requirements for development of medical device software.
Although it is not
Consolidated version of the AI Act published
A consolidated version of the AI Act that includes revisions introduced in July 2026 has been published. Contrary to expectations in some corners, software as a medical device remain classified as high risk
European Commission publishes Version 22 of Q&A concerning Safety Features for Medicinal Products for Human Use
A consolidated version of the AI Act that includes revisions introduced in July 2026 has been published. Contrary to expectations in some corners, software as a medical device remain classified as high risk devices within the Act. There are a number of
Updates to the MDCG Guidance on Classification of Medical Devices
MDCG 2021-24 rev.1 Guidance on classification of medical devices has been updated. Among the updates are:
Pilot programme to be launched to support breakthrough medical devices and in vitro diagnostics
In the second quarter of 2026, the European Medicines Agency (EMA) will launch a pilot programme to support breakthrough medical devices and in vitro diagnostic devices. The purpose of the programme will be to test a pathway that is intended to accelerate patient access to highly innovative technologies, while maintaining the EU’s high standards for safety and performance. Manufacturers participating in the pilot will benefit from
Q&A concerning the practical aspects of Manufacturers’ Obligation to Inform in case of Interruption or Discontinuation of Supply of certain Medical Devices and IVDs
The European Commission has also published a Q&A document on the practical aspects of the notification obligations provided in Article 10a of the MDR and the IVDR concerning interruption in supply or discontinuation of supply of certain medical devices and how these should be fulfilled. health in one or more EU Member States
Article 10a Decison Tree
Article 10a of the MDR governs obligations imposed on manufacturers and the competent authorities of EU Member States in case of interruption or discontinuation of supply of certain devices. The European Commission has developed an Article 10a Decision tree. The purpose of the Decision tree is to provide support to manufacturers
Two European Parliament Committees vote to delay entry into application of AI rules for Medical Devices
The European Parliament’s Internal Market Committee and Civil Liberties Committee have voted by a substantial majority to postpone certain rules on artificial intelligence which will have an impact on medical device manufacturers.
The postponement is intended to prevent
Update of European Commission PMSV reporting forms page
The European Commission has updated its PMSV reporting forms page to reflect the new version (7.3.1) of the Manufacturer Incident Report (MIR form) that was published in December 2025.
As part of the update the European Commission took the opportunity a
Mandatory Use of EUDAMED Modules for Medical Devices
Competent authorities are also publishing reminders to manufacturers that four EUDAMED modules become mandatory on 28th May 2026. The modules
Team-NB has published a letter on cybersecurity in medical devices
Team-NB, the European Association of Medica devices Notified Bodies, has published a letter concerning cybersecurity in medical devices. The Association welcomed revisions included in the recent proposed revisions to the MDR and IVDR intended to strengthen cybersecurity in this context.
However, it considered that decisions concerning availability of medical devices and safety of patients remain with the “governance bodies” established
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.
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
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:
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
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