Regulatory Updates
May “In All Other News”: swissdamed Webinar, AI Act Postponed, & More
Overview of the May 2026 news not already reported: AI Act postponement, new EUDAMED functionality, proposal to amend the EU-Monaco ...
New swissdamed Registration Fees Starting January 2027
Swissmedic announced its new swissdamed device registration fee structure, which starts January 2027. Click here to find out the fees, ...
EUDAMED Now Mandatory: Update on National Requirements and Resources
EUDAMED officially becomes mandatory starting May 28, 2026. Here we outline the requirements for medical device manufacturers, including how EUDAMED ...
UK Draft Regulation: New UKCA Requirements & International Reliance
The MHRA published a draft of its new regulation, now open for comment on the WTO website. Click here to ...
Implementing Regulation (EU) 2026/977: Notified Body Requirements
New Regulation 2026/977 establishes binding CE marking timelines, clock-stop limits, and cost transparency for MDR/IVDR Notified Bodies. Read more here.
April “In all other news”: New Team-NB Clinical Guidance, Borderline Manual v5, & more
Find here an overview of the April news not already reported: Team-NB new and updated guidance, Article 10a decision flow ...
MDCG 2021-24: ‘Guidance on Classification of Medical Devices’ Updated
MDCG 2021-24 has been updated. Rev.1 revises classification guidance across multiple rules including Rules 8, 9, 10, 12, 16, and ...
EU Commission EUDAMED Training: Actor, UDI/Devices, & NBs/Certificates Modules
The Commission is hosting web-streamed trainings all day on the following EUDAMED modules: Actor, UDI/Devices, Notified Body & Certificates. Click ...
Three New European Harmonized Standards Under the MDR
Three standards have been newly harmonized under the EU MDR. Click here for the update. Plus, a link to a ...
March “In All Other News”: MDR/IVDR Reform Status, Minor Updates to MIR Form, and More
March EU, UK, and Swiss regulatory updates not already individually reported: MDR/IVDR reform progress, MIR Form 7.3.1 update, swissdamed manual ...
MDCG Standards Working Group Meeting: ISO/IEC Court Case & New EU Rep Symbol Timing
MDCG Standards Working Group Feb 2026 updates: EC REP to EU REP symbol adoption and transition timing, and status of ...
New Draft Delegated Acts: Expanded List of Well-Established Technology (WET) Devices
The EU Commission published two draft delegated acts, proposing to expand the MDR well-established technology list. Learn what devices are ...
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 Functionality, & 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.