Swissmedic Updates CAPA Plan Content Requirements for Medical Devices
Swissmedic publishes updated CAPA plan requirements for medical devices, effective April 2026. Key impacts for manufacturers and compliance strategies explained.
Swissmedic updates guidance on clinical investigations of medical devices
Swissmedic releases updated guidance on clinical investigations of medical devices, clarifying Category A vs C studies, ISO 14155 compliance, and safety reporting requirements for manufacturers.
FDA launches READI-Home Innovation Challenge focused on reducing hospital readmissions
The FDA launches the READI-Home Innovation Challenge to support medical devices aimed at reducing hospital readmissions through home-based care solutions.
Health Canada publishes new guidance on “significant change” for medical devices
Health Canada clarifies when medical device changes require licence amendments. Key insights for manufacturers on risk, software, and design changes.
Notified Bodies Raise Concerns on Targeted MDR/IVDR Revision
Notified bodies highlight key risks and proposals in the EU MDR/IVDR targeted revision, including clinical evidence, WET, and regulatory oversight.
Swissmedic Issues Minor Update to Guidance on User Incident Reporting
Swissmedic updates guidance on medical device incident reporting. Key timelines, obligations, and implications for manufacturers explained.
MHRA Issues Updated Guidance on Submitting Clinical Investigation Proposals
MHRA releases new 2026 guidance on clinical investigation submissions via IRAS. Key requirements, timelines, and implications for manufacturers.
European Commission publishes EUDAMED Release Notes v2.25.2
The European Commission releases EUDAMED v2.25.2 with new validation rules, certificate controls, and API access. Key implications for medical device manufacturers.
European Commission Expands List of Class IIb Implantable Devices Exempt from Individual Technical Documentation Assessment
The European Commission expands the list of Class IIb implantable devices exempt from individual technical documentation assessment under MDR Article 52(4).
Portuguese MedTech Market: Overview of Opportunities and Requirements for Manufacturers
Overview of the Portuguese MedTech market, including regulatory requirements, market access pathways, and opportunities for manufacturers entering Portugal.
Swissmedic Publishes “Good Practice for Materiovigilance in Hospitals” (GPMV-Spital)
Swissmedic releases GPMV-Spital, a new framework for materiovigilance in hospitals. Understand the impact on medical device manufacturers and post-market surveillance.
European Parliament Adopts Amendments to Simplify AI Act Implementation (“Digital Omnibus on AI”)
EU Parliament adopts AI Act simplification package. Key changes impact high-risk AI timelines, MDR alignment, and compliance requirements.
European Commission publishes results of 18th Notified Body survey under MDR and IVDR
Latest European Commission data shows MDR and IVDR application volumes, certification timelines, and submission quality based on the 18th Notified Body survey (October 2025 data).
FDA expands TAP Pilot: increased scope and participation
FDA expands its TAP Pilot with more devices and new areas. Key updates and what medical device manufacturers need to know.
Team-NB clarifies transfer of surveillance for legacy devices under MDR Article 120
Team-NB releases a position paper defining how manufacturers can transfer notified body surveillance for legacy devices under MDR Article 120, including key requirements, timelines, and responsibilities.
Cybersecurity Becomes a GMP Priority Under the EU Cyber Resilience Act
The EU Cyber Resilience Act is reshaping GMP expectations for laboratories. Learn how cybersecurity, data integrity, and validation requirements will impact manufacturers.
MedTech Europe Calls for Greater Alignment in EU Digital Omnibus Proposals
MedTech Europe highlights key challenges in the Digital Omnibus, including AI Act timelines, GDPR updates, and Data Act implications for manufacturers.
EU Expert Panel Identifies Clinical Evidence Limitations for Bioabsorbable Orthopaedic Screws under MDR CECP
EU expert panel highlights clinical evidence gaps, benefit-risk concerns and PMCF weaknesses for bioabsorbable orthopaedic screws under MDR.
Swissmedic publishes updated guidance on Systems and Procedure Packs (SPP)
Swissmedic updates guidance on systems and procedure packs. Key obligations, CH-REP requirements, and impact for medical device manufacturers.
European Commission Expands MDR List of Devices Exempt from Clinical Investigations
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.