MDCG Standards Working Group Meeting: ISO/IEC Court Case & New EU Rep Symbol Timing
30 March 2026
Three New European Harmonized Standards Under the MDR
7 April 2026- Europe
- MDR/IVDR Reform Progress
- MIR Form 7.3.1 Updated
- New EMDN Training Recording
- MDCG 2025-8 on Master UDI-DI Revised
- Notified Bodies Survey on Certifications & Applications
- EURL Call for Applications
- CECP Decisions
- Team NB Position Paper on MDR/IVDR Reform
- Team NB MDR Clinical Training
- Team NB MDR Technical Documentation Training
- Team NB IVDR Technical Documentation Training
- UK
- Switzerland
Below is an overview of the March 2026 news items that were not already individually reported. Please see our Regulatory Updates main page for those topics, e.g., Draft Act to expand the list of Well Established Technologies.
Europe
MDR/IVDR Reform Progress
The Commission hosted a ‘High-level Conference on Medical Devices’ on 16 March 2026. The recording of the livestream is available: HERE
One of the topics was a “fireside chat” with the Cypriot Council Presidency’s Minister of Health, Neophytos Charalambides and a Member of the European Parliament, Tomislav Sokol. In it, they discussed the steps the European Council and Parliament are taking to move the MDR/IVDR reform initiative forward.
Mr. Charalambides advised they intend to conduct the first readings shortly, and then collect member states’ comments and pass them together to the Irish presidency, which will take over from the Cyprus presidency starting 1 July 2026. The purpose is to allow the incoming Irish presidency to already have the position of the core legislators from the beginning, so they can immediately begin work on it.
Mr. Sokol advised the file has been forwarded and is with the subcommittee. They expect it will take at least 2-3 months before the first draft report is made but are hopeful that the negotiation process will start before summer.
Further, the MDR/IVDR reform tracker was updated to note that on 23 March 2026, the European Council formally started its technical review of the proposal.
MIR Form 7.3.1 Updated
Minor updates were made to the form on 23 March 2026: HERE
New EMDN Training Recording
The Commission published the recording from its second EMDN training: HERE
“The second training provided an overview of the EMDN, its structure, the consultation process, and Annex XVI. It also covered the practical application of code selection and update requests, as well as perspectives from Competent Authorities, Notified Bodies, and industry. The session concluded with a Q&A and closing remarks.”
MDCG 2025-8 on Master UDI-DI Revised
MDCG 2025-8 on Master UDI-DI for spectacle frames, spectacle lenses and ready-to-wear reading spectacles was revised: HERE
Two minor corrections were made to pages 16 and 18.
Notified Bodies Survey on Certifications & Applications
An updated report was published: HERE
Some takeaways from the presentation:
- Incomplete submissions remain a persistent problem under MDR.
- IVDR applications and certificates both jumped sharply in the most recent period.
EURL Call for Applications
The European Commission has issued four new calls for applications related to EURLs: HERE
It is for the following areas:
- EURL for Public Health on Clostridioides difficile
- EURL for Public Health on Sexually Transmitted Bacteria
- EURL for Public Health on Mycobacteria
- EURL for Public Health on Invasive Bacteria
CECP Decisions
Two new Clinical Evaluation Consultation Procedure decisions were published:
Team NB Position Paper on MDR/IVDR Reform
‘MDR/IVDR revision: impact on the sector’ is available: HERE
Some takeaways from their position paper:
- They find the €2.1 billion savings figure mathematically questionable. Team-NB points out that the Commission’s projected savings from reduced conformity assessment costs exceed the total combined revenue of all NBs (€475 million in 2024).
- They find the mandatory SME fee discount to have a design flaw. Because more than half of micro and small manufacturers on the EU market are non-EU based, a blanket fee reduction tied to company size rather than EU establishment could end up subsidizing non-EU competitors at the expense of EU-based SMEs.
- They raised concerns that reduced QMS audits, unannounced audits, and PSUR reviews could reduce patient safety.
Team NB MDR Clinical Training
Team-NB will host another training for manufacturers on 28 May 2026. More information is available: HERE
Team NB MDR Technical Documentation Training
Team-NB will host another training for manufacturers on 29 April 2026. More information is available: HERE
Team NB IVDR Technical Documentation Training
Team-NB will host another training for manufacturers on 2 July 2026. More information is available: HERE
UK
New Clinical Trials Webpages
The following new webpages are available:
- Clinical investigations in Great Britain
- Clinical investigations in Northern Ireland
- Medical devices that need a clinical investigation
- Clinical investigations: compiling a submission
- Clinical investigations: investigators’ responsibilities
- Clinical investigations: statistical considerations
- Clinical investigations: biological safety assessments
- Clinical investigations for electrically powered devices
- Approving clinical investigations
Clinical Trials Regulation Webinar Recording
The MHRA added a new recording, from a webinar that took place 12 March 2026. It is available: HERE
New Regulatory Advice Meetings Form
The MHRA updated its Regulatory Advice Meetings webpage to add a new form: HERE
The form asks for relevant background information, including for the list of questions the requestor would like advice on.
Switzerland
Swissmedic Guidance Documents Updated
The updated guidance documents are available: HERE
The list of documents updated are:
- Obligations for Economic Operators
- Devices With an Intended Medical Purpose
- Systems and Procedure Packs
- Procurement Of Medical Devices in Health Institutions
- Clinical Investigations with Medical Devices
- 3D Printers Medical Devices
- swissdamed Service Agreement
- Content Requirements for CAPA Plan
- Incident Report User
Some of the guidance documents contained minor content changes, while others were updated simply to note Swissmedic’s new phone number.
swissdamed Functionality Updates
Machine-to-Machine (M2M) functionality and manual entry (online editor) will be available in swissdamed by end of June 2026.
Swissmedic updated its swissdamed device registration webpage on 2 March 2026 to advise M2M and manual entry would be available by the end of March. However, on 25 March 2026, the webpage was updated again to note it would instead be “gradually introduced into the production environment by the end of June 2026”.
In the meantime, the new M2M guidance is available: HERE
