Regulatory Updates
November “In All Other News”: UK Update on Indefinite CE Marking, MIR Form Delayed, and more
Regulatory updates not already reported on individually for Nov 2025, including MIR form delays, MDR/IVDR reform, Notified Body capacity updates, ...
EUDAMED Officially Published Today: What Manufacturers Need to Know
UDAMED implementing act published in the OJEU. Learn the 6-month and 18-month registration deadlines for medical device manufacturers.
Team-NB Transfer Agreement Template: MDR Applications and Legacy Devices
Overview of Team NB’s new MDR transfer agreement, how it works, and what manufacturers must consider when moving applications and ...
October “In All Other News”: MHRA Clinical Guidance, AI Updates, and more
Regulatory updates not already reported on individually for October 2025, including EU HTA rules, MHRA clinical guidance changes, AI Act ...
Why Harmonized Standards Are Stuck: ISO/IEC v EU Commission Legal Dispute Explained
Legal disputes between the EU Commission and ISO/IEC over copyright and access are slowing standardization efforts. No new international standards ...
Four New European Harmonized Standards Published Under the MDR
Four new harmonized standards have been added under the MDR, covering surgical drapes, clean air suits, face masks, and sterilizers. ...
UK MHRA’s Annual Registration Fee: New Guidance and Registration Webpages Updated
MHRA publishes detailed guidance on the 2026 annual registration maintenance fee, including DORS updates, payment steps, and timing.
September “In All Other News”: EU Borderline & Classification Manual Updated, and more
September "all other" updates: new EU borderline and classification decisions, Master UDI rules for optical products, Team-NB best practice guidance, ...
UK MHRA to Implement Annual Medical Device Registration Fees Starting April 2026
Starting April 2026, the MHRA will replace the current one-time registration fee with a new annual fee, based on GMDN ...
MDCG Working Group Releases Draft Version of Manufacturer Trend Report Form & Guidance Docs
MDCG releases draft Manufacturer Trend Report form and guidance. While still drafts (and subject to change), they offer a sneak ...
UK: PMS Report Guidance, Provide Feedback on Standards, & Progress on New Regulation
UK MHRA updates: PMS Report guidance, plans on future standards, and status of the pending regulatory changes, which will introduce ...
EU Commission Launches Call for Feedback: Targeted Revision of the MDR & IVDR (8 Sep–6 Oct 2025)
The EU Commission launched a Call for Evidence on the targeted revision of the MDR/IVDR. Stakeholders can provide feedback between ...
Registration for Hybrid EUDAMED Workshops Now Open: 8 Oct 2025 (Rome) & 3 Dec 2025 (Brussels)
The Commission opened up registration for two new hybrid EUDAMED workshops: Rome (Oct 2025) & Brussels (Dec 2025). Click here ...
August “In All Other News”: Proposed Cybersecurity Amendments, MDCG 2024-14 Revised, and more
August regulatory updates not reported on previously: Portugal clarifies software interface language requirements, new Team-NB MDR Clinical training, and more.
The swissdamed Device Registration Module: How to gain access, register devices, and more
Swissmedic just released the swissdamed UDI/Device Module. Learn how to register devices as of Aug 2025. Covers XML upload requirements, ...
swissdamed Device Module Opens for Voluntary Use, New SPP Guidance, and eIFU & MIR Form Updates
Swissmedic updates: swissdamed device registration to open soon for voluntary use, new SPP guidance, EU eIFU framework adopted, and MIR ...
EU Commission Launches Next Steps on MDR/IVDR Evaluation, Opens New “Have Your Say”
The Commission has opened a new “Have Your Say” initiative—marking the next step in its ongoing review of the MDR ...
July “In All Other News”: MDR/IVDR Reform, UK to Align with EU IVD Common Specifications, Team-NB MDR Training, and more
July regulatory updates not reported on previously: orphan & paediatric expert panels, Master UDI-DI timelines, Team-NB papers, MedTech Europe on ...
UK Updates: International Reliance, IVDs, UDI, and Possible Indefinite Recognition of CE Marking
MHRA updates on the new international reliance program, IVD reclassification, new IVD conformity assessment routes, UDI, and exploring indefinite recognition ...
EUDAMED Mandatory Use: Insights and Timeline from the June 26, 2025 MDCG Working Group Meeting
The MDCG EUDAMED Working Group met on 26 June 2025. They discussed the status of the independent audit, timing for ...
June “In All Other News”: MDCG Q&A on the AI Act, New MDSAP Website, MIR Form Updates & More
Collection of June 2025 updates not already reported on individually: MDCG 2025-6 on the AI Act & MDR/IVDR, minor updates ...
MDCG 2025-5: Q&A Regarding Performance Study Requirements Under the IVDR
MDCG 2025-5 was recently published. Understand how it clarifies IVDR performance study requirements, submissions, and study types for IVD manufacturers.
eIFUs Now Allowed for All Professional Use Devices: EU Amending Regulation 2025/1234 Published
The Commission published a new amending regulation, which expands the scope of eIFUs to all professional use devices. It includes ...
MDCG 2019-11 Rev. 1: Qualification and Classification of Software under the MDR & IVDR
MDCG 2019-11 on the qualification and classification of software has been updated. It significantly expands certain sections, and adds new ...
Targeted Evaluation of the MDR & IVDR: Summary Report on Open Consultation Responses
The Commission summarized the feedback received from its open consultation to re-evaluate the MDR/IVDR. Find out what respondents said, and ...
MDCG 2025-4: Making Available of Software Apps & Legal Status of App Platform Providers
MDCG 2025-4 clarifies if/when an app platform provider is considered an economic operator under the MDR/IVDR. Click here for the ...
UK MHRA Updates & Adds New Resources on Post-Market Surveillance (PMS) and Vigilance
The MHRA published new and updated guidance for the upcoming PMS regulation, effective starting June 16, 2025: explainer video, updated ...
May “In All Other News”: EUDAMED Progress, EU on MDSAP, Tips on the New Tariffs, and More
Collection of May 2025 updates not already reported on individually: MDCG Working Group updates, Swiss MedTech's tips on the new ...
New EMDN Resources: Helpdesk Now Live, MedTech Europe’s ‘Practical Guide’ & more
The Commission launched its new EMDN Helpdesk and MedTech Europe published a new EMDN guidance document. Find those resources, and ...
MHRA Updates MORE Vigilance Platform Guidance to Prepare for Upcoming PMS Regulation
Due to the new UK PMS regulation, the MHRA published updates to its MORE vigilance reporting portal. Find out what's ...