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
Updated ICH E2D(R1) on post-approval safety data comes into effect in the EU
The updated ICH E2D(R1), which provides guidance on management and reporting of post-authorisation individual case safety reports, came into effect on 18th March 2026.
This is the first revision of ICH E2D(R1) in over 20 years.
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
HTA: New Opportunity to Apply for Joint Scientific Consultations
On 1st April 2026, the European Commission will open the second requaest period for joint scientific consultations (JSCs) for 2026. The purpose of the JSCs are to provide both marers and pharmaceutical companies with an opportunity to consult
EMA introduces three new features for use in PRIME
The EMA has launched three new features in PRIME. These are intended to support and streamline continued scientific dialogue, give developers faster answers, and provide better support in preparation for the submission of a marketing authorisation application.
EDPB-EDPS JOINT OPINION 3/2026 on the proposed European Biotech Act
The European Data Protection Board (EDPB) and the European Data Protection Supervisor (EDPS) have adopted a joint opinion on the European Commission proposal for a Biotech Act.
The joint opinion underlines the importance of ensuring that, while
Team-NB Position Paper on MDR/IVDR revisions
Team-NB, the European Association of Medical devices Notified Bodies, has published its Position Paper on the European Commission’s proposed revisions to the MDR and the IVDR. While the Association acknowledges that the proposed revisions provide opportunities to improve predictability, transparency and efficiency in conformity assessment, it has expressed concern regarding some aspects of the proposed revisions. These include what Team-NB perceives as reductions in
EMA review of stepwise paediatric investigation plan pilot
The European Medicines Agency (EMA) has published its review of the stepwise paediatric investigation plan (sPIP) pilot launched in 2023. The sPIP is intended to manage exceptional paediatric development programmes in which critical data are unavailable at the time of submission of initial Paediatric Investigation Plan (PIP), thereby constraining evidence-based planning of key study elements. The Report concluded that the stepwise approach demonstrated feasibility and value where it was used in exceptional cases.
HMA/EMA Guideline on good pharmacovigilance practice on pregnant and breastfeeding women and their children exposed in utero or via breastmilk
On 2 February 2026, the Heads of Medicines Agencies (HMA) together with the EMA, published a Guideline on good pharmacovigilance practices (GVP) Product- or Population-Specific Considerations III: Pregnant and breastfeeding women and their children exposed in utero or via breastmilk. The Guidance provides direction concerning the conduct of pharmacovigilance processes in relation to pregnant or breastfeeding women and children exposed in utero or via milk to medicinal products.
Call for feedback concerning revisions to the MDR and the IVDR proposed by the European Commission
The European Commission has launched a call for feedback concerning the proposed Regulation intended to simplify and reduce the burden imposed by existing rules governing medical devices and in vitro diagnostic medical devices in the EU that was published in mid-December 2025.
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
Final text of the Pharma Package published
The final drafts of the proposed Directive and proposed Regulation have been published. The revised texts reflect the revisions proposed by the Council and the European Parliament and related compromise provisions. Formal adoption of the provisions is anticipated
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 …
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
MHRA Field Safety Notices – Guidance for Manufacturers
The MHRA has published guidance for manufacturers of medical devices concerning field safety notices. The guidance includes advice regarding the steps to ensure good traceability, and advice concerning various elements of Field Safety Notices (FSNs).
EMA Guideline on Inclusion of Pregnant and Breastfeeding Individuals in Clinical Trials
The European Medicines Agency (EMA) has introduced a draft new guideline on the inclusion of pregnant and breastfeeding women in clinical trials. The goal is to ensure that developers of clinical trials generate robust clinical data in relation to pregnant and breastfeeding women, so that these individuals and their healthcare providers can make informed, evidence-based decisions when using medicines.