Regulatory Updates
New swissdamed Funcationality : Swiss Importer Linkage to Manufacturers
swissdamed has been updated to allow Swiss importers to link to manufacturers. Read our article for more on the deadline ...
Sep 2026 “In All Other News”: UK Reform Bill, Vigilance Contact Updates, and More
Overview of the September 2026 news not already reported: MDR/IVDR Reform progress under new Presidency, IMDRF September meeting presentations, and ...
2026 UKCA Marking FAQs: Which Devices Need UKCA Marking, Deadlines, and More
Which devices need UKCA Marking in 2026; will CE Marking will be recognized indefinitely in Great Britain; what are the ...
MDCG 2020-16 rev.5: EU IVDR Classification Guidance Updated
MDCG 2020-16, the guidance on IVD classification, was updated to clarify the rationale and revise examples for Rule 7 under ...
New Swissmedic Webinar on swissdamed Scheduled for November 2026
Swissmedic will be hosting a second webinar on swissdamed this November 2026, including an overview of how to use the ...
August Updates: New EUDAMED Functionality, New IMDRF Guidance, and More
August 2026 regulatory roundup covering EUDAMED updates, PPWR FAQ changes, new MHRA fee consultation, new IMDRF guidance on SaMD PCCPs, ...
July “In All Other News”: MDCG 2026-5, MDR/IVDR Reform Progress, and more
Overview of the July 2026 news not already reported: new MDCG guidance clarifying who is responsible for UDI assignment, updated ...
Commission Publishes Updated Links to Notified Body Fee Lists
The European Commission has published an updated list of each Notified Body's (NB) price lists, which NBs are required to ...
June “In All Other News”: WET List Formally Updated, MDCG 2026-4 on SS(C)Ps, and more
Overview of the June 2026 news not already reported: Change in SS(C)P process for manufacturers, Guidance on the Packaging and ...
Appendix to MDCG 2021-5: Transitioning to the New ‘EU REP’ Symbol
The EN ISO 15223-1 'Authorized Representative' symbol is officially changing from 'EC REP' to 'EU REP'. Here we outline the ...
New & Updated MDR/IVDR Harmonized Standards Published
Standards have been updated and newly harmonized under the EU MDR/IVDR, including a change that impacts labeling for non-EU based ...
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 ...