The EU Pharma Package - what will, and what will not, change following adoption
the EU Pharma Package has not yet been adopted, but it will be soon. The final European Parliament vote is anticipated for November 2026.
It is unlikely that there will be any fundamental changes in the provisions of either the current draft Directive that will replace Directive 2001/83/EC or, the current draft Regulation that will replace Regulation (EC) No 726/2004 prior to adoption.
While the new provisions will result in substantial changes to the existing rules governing medicinal products in the EU, there are provisions that will remain unchanged.
First ever national HTA relying on an EU JCA results in rejection of product for reimbursement
The national Health Technology Assessment (“HTA”) by the Irish National Centre for Pharmacoeconomics (“NCPE”) of Novartis’ Itvisma was the first HTA in which, according to the NCPE, an EU Joint Clinical Assessment
New EMA guidance on the IRIS platform
European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure This guide has been produced to help new users of IRIS to complete the prerequisite steps before accessing the platform. Most of these steps are independent from the IRIS
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
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.