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.
FDA updates SOPP 8412 on product labeling review
FDA releases SOPP 8412 Version 10 detailing labeling review procedures for drugs and biologics under BLA, NDA, and ANDA pathways.
MDCG 2025-8 Rev.1: Guidance on Master UDI-DI for Spectacle Devices
MDCG 2025-8 Rev.1 provides guidance on Master UDI-DI implementation for spectacle frames, lenses, and reading spectacles under EU MDR. Learn key requirements, timelines, and assignment rules.
European Reference Networks Continue to Expand: What It Means for Medical Device Manufacturers
Discover the latest European Commission update on ERNs and what their expansion means for medical device manufacturers in rare disease areas.
FDA Publishes Updated Guidance on Pyrogen and Endotoxins Testing
FDA releases updated guidance on pyrogen and endotoxin testing. Key clarifications for medical device and pharma manufacturers.