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
Commission Publishes Updated List of Notified Bodies’ Standard Fees
The European Commission has published an updated list of notified bodies’ standard fees.
The list is published in fulfilment of the obligation imposed on Notified Bodies by Article 50 of the MDR and Article 46 IVDR to establish and publish lists of their standard fees. The information provided in the list is not binding on either the Notified Bodies or their clients. It is rather a reference document to help manufacturers determine potential costs related to interactions with Notified Bodies.
The list of standard fees will potentially become increasingly useful
MDCG Position Paper on UDI Assignment between Manufacturers and Distributors
With the intention of providing clarification concerning which entity should be responsible for seeking and registering UDI-DIs in the EU, the MDCG has published a related Position Paper. The Paper is specifically intended to clarify the role of distributors in acquisition of UDI-DI codes from EU UDI issuing entities.
The Position Paper:
Commission publishes Monitoring of Notified Bodies: new MDR and IVDR reports
The European Commission has just published the most recent Monitoring of Notified Bodies: new MDR and IVDR reports. These are reports, required by Article 44.12 of the MDR and Article 40.12 of the IVDR, that present the results of monitoring and on-site assessment activities by EU Member States regarding notified bodies. The reports are submitted
Revisions to Annex 19 Eudralex Volume 4 concerning reference and retention samples for parallel imports
The provisions of Annex 19 to Eudralex Volume 4 concerning reference and retention samples for parallel imported, parallel distributed, and parallel traded medicinal products will change from 24 September 2026.
Previous related requirements provided that, where the secondary packaging is not opened, only the packaging material used needs to be retained. The revised Annex amplifies this requirement to require physical samples
New MDCG Position Paper on Management of SSCP and SSP in EUDAMED
The MDCG has published a brief Position Paper concerning responsibility for the management of summary of safety and clinical performance (SSCP) and the summary of safety and performance (SSP) following their upload to EUDAMED. Until now, Article 32.1 of the MDR imposed responsibility for uploading SSCPs and SSPs on the notified body.
Two Commission Delegated Regulations concerning exemptions applying to some implantable devices and Class III devices
Two Commission Delegated Regulations concerning exemptions applying to some implantable devices and Class III devices were published in today’s Official Journal of the European Union, 19 June 2026. have just been published.
Article 52.4 of the MDR requires, with limited exceptions, that each Class IIb implantable device be the subject of an individual conformity assessment. Article 52.5 of the Regulation provides an exemption
New European Commission introducing presumption of conformity with EU ISO standards in new areas
The European Commission has published a new Implementing Decision concerning EU ISO harmonised standards for:
biological evaluation of medical devices;
symbols to be used with information to be supplied by the manufacturer;
medical electrical equipment;
transfusion equipment for medical use;
ophthalmic
Promotion of Medicinal Products on social media
The Irish Health products Regulatory Authority (HPRA) has updated its webpage dedicated to the promotion of medicinal products to the public on social media.
HTA GG publishes Guiding Principles on Data Transparency
The HTA GG, the Member State Coordination Group on Health Technology Assessment, has published Guiding Principles on Data Transparency. The purpose of the document is to provide general principles to be used when assessing requests for confidentiality from health technology developers within the context of joint clinical assessments within the context of Joint Clinical Assessments (JCA).
The document distinguishes between what
Q&A on general methodological and procedural issues for joint clinical assessments
The European Commission has published an updated version of its Questions and Answers on general methodological and procedural issues for joint clinical assessments. The Q&A includes responses to questions concerning:
New guidance on frequently asked questions about the publication of the Joint Clinical Assessment report
The European Commission has published a document addressing frequently asked questions about the publication of the Joint Clinical Assessment report. The guidance addresses questions including:
What documentation, other than the procedurally compliant JCA and summary report, that have been established in the course of a specific JCA procedure will be made publicly available;
Whether only the “core dossier” (without appendixes) will be made public;
Whether the clinical data included in the submission file to
New Manufacturer Incident Report
A new version of the Manufacturer Incident Report (MIR) has been published on the European Commission website. The new MIR become mandatory on 1 May 2026.
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