Regulatory Updates
IMDRF Adverse Event Reporting (AER) Terms, Terminology, & Codes: Annexes Revised
The IMDRF published its annual update to the Adverse Event Report (AER) terms, terminology, and codes. Click here for the ...
Feb “In All Other News”: MHRA Guidance Updates, New swissdamed Funcationality, & More
Feb 2026 news not already reported: UK public database now shows brand/trade names, swissdamed M2M and manual registration launch, IMDRF ...
UK Consultation on CE Marking: MDD Extension, Indefinite Recognition, and International Reliance
MHRA proposes MDD transition extension to Dec 2028, indefinite CE marking recognition, and international reliance. Consultation closes April 10, 2026.
Jan 2026 “In All Other News”: EMDN, EUDAMED, WET Updates, and more
Jan 2026 news not already reported: New EMDN codes with email notifications, WET list expansion in Q1 2026, swissdamed webinar, ...
18 New EU MDR/IVDR Harmonized Standards & UK Designated Standards
New EU MDR (12) and IVDR (6) harmonized standards have been published, plus an updated 2026 UK designated standards list. ...
MDR/IVDR Reform Updates: WTO Publication & Redlined Versions
The EU Commission published a marked-up version of the MDR/IVDR reform and published it to the World Trade Organization (WTO). ...
MDR/IVDR Reform Proposal: Open Feedback Period 7 January 2026 – 4 March 2026
Comment on the draft MDR/IVDR reform legislation before March 4, 2026. The proposal simplifies CE marking, reduces NB involvement, and ...
December “In All Other News”: Draft Act to Revise NB Requirements, New MDCG Docs, & more
December 2025 regulatory updates not previously already reported on: breakthrough device guidance MDCG 2025-9, draft NB legislation, UK MHRA changes, ...
MDCG 2025-10: New MDR/IVDR Guidance on Post-market Surveillance (PMS)
New MDR/IVDR guidance on PMS for medical devices and IVDs. Outlines expectations around 'proactive' data collection, custom-made device requirements, and ...
Manufacturer Incident Report (MIR) Form 7.3.1 Updated: Mandatory May 1, 2026
MIR Form 7.3.1 becomes mandatory May 1, 2026 for EU and Swiss medical device vigilance reporting. Key updates include duplicate ...
EU Device Reform Package: Fee Relief, Down-Classification, and More
EU proposes major MDR/IVDR relief: no CE certificate expiry, up to 50% NB fee cuts for small enterprises, extended PSUR ...
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 ...