Swissmedic has updated the swissdamed Actors User Guide (v2.0), introducing AGOV login migration updates, mandate transfer functionality, and clarified actor management requirements for medical device manufacturers and authorised representatives in Switzerland.

Health Canada now requires mandatory use of the Regulatory Enrolment Process (REP) and CESG for Class II–IV medical device submissions. Learn what manufacturers must do and how the new IMDRF ToC requirements may impact regulatory workflows.

Swissmedic releases updated guidance on medical device software (MDSW), covering qualification, classification, and regulatory requirements under MDR/IVDR.

MDCG publishes Revision 2 of EMDN guidance, clarifying code assignment, updates, and EUDAMED requirements under MDR and IVDR.

Health Canada eliminates reconsideration requests for priority review and NOC/c decisions from April 2026. Key regulatory impacts for drug sponsors explained.

MHRA updates its clinical investigations guidance and introduces a 2026–2027 fee waiver pilot for SMEs. Key requirements for medical device manufacturers explained.

MDCG updates medical device classification guidance under EU MDR. Key changes manufacturers must review for compliance and documentation.

MHRA updates clinical trial record retention rules to 25 years. Key implications for manufacturers, TMF management, and UK regulatory compliance.

FDA updates SOPP 8212 on breakthrough therapy designation. Key changes in timelines, communication, and lifecycle management for manufacturers.

Health Canada clarifies when medical device changes require licence amendments. Key insights for manufacturers on risk, software, and design changes.

Notified bodies highlight key risks and proposals in the EU MDR/IVDR targeted revision, including clinical evidence, WET, and regulatory oversight.

Swissmedic updates guidance on medical device incident reporting. Key timelines, obligations, and implications for manufacturers explained.

EU Parliament adopts AI Act simplification package. Key changes impact high-risk AI timelines, MDR alignment, and compliance requirements.

The European Commission expands the list of implantable and Class III devices exempt from clinical investigations under MDR Article 61. Key regulatory update for manufacturers.

FDA releases SOPP 8412 Version 10 detailing labeling review procedures for drugs and biologics under BLA, NDA, and ANDA pathways.

FDA releases updated guidance on pyrogen and endotoxin testing. Key clarifications for medical device and pharma manufacturers.

Swissmedic has released Version 20.0 of its “Formal Requirements” guidance, effective 1 March 2026. Learn what pharmaceutical manufacturers need to know about submission formats, documentation requirements and parallel import updates.

Team-NB warns that proposed MDR and IVDR revisions could reduce regulatory scrutiny and create unintended consequences for EU manufacturers, despite improvements in digitalisation and innovation pathways.

Swissmedic has published version 1.2 of its guidance on the Medical Device Publication Service, clarifying how Field Safety Corrective Actions and Field Safety Notices are published and accessed.

New Swissmedic guidance formalises the process for Scientific GMDP Meetings with Swiss establishment licence holders. Effective January 2026. Download the official document here.