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:
New UK Clinical Trials Regulation enters into force
The Medicines for Human Use (Clinical Trials)(Amendment) Regulations 2025 entered into force in the UK on 28 April 2026. The Regulations amend the existing Medicines for Human Ise (Clinical Trials) Regulations 2004. The purpose of the new Regulation is to protect trial participants, strengthen patient safety, and accelerate
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
CTIS New Sponsors’ FAQ
The EMA has published a new Frequently Asked Question (FAQ) document concerning the Clinical Trials Information System (CTIS) document. The purpose of the FAQ document is to help clinical trial sponsors use the CTIS more effectively by providing responses to the most frequently asked questions that trial sponsors may have when creating and submitting clinical trial applications through the CTIS.
The document is divided into
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