EDPB Releases New 2026 DPIA Template for Public Consultation
The EDPB publishes a new 2026 DPIA template to standardise GDPR compliance. What it means for medical device manufacturers.
FDA Issues Draft Guidance on NGS-Based Safety Assessment for Genome Editing Therapies
FDA releases draft guidance on next-generation sequencing (NGS) for genome editing safety assessment. Key implications for gene therapy manufacturers and IND submissions.
FDA Updates eMDR Framework with ESG NextGen Submission Portal
The FDA has replaced the WebTrader system with the ESG NextGen portal for eMDR submissions. Learn what this means for medical device manufacturers and reporting obligations under 21 CFR Part 803.
FDA Issues New Guidance on Bioanalytical Method Validation for Biomarkers
FDA issues new guidance on biomarker validation. Learn key requirements and what manufacturers must consider for global regulatory compliance.
FDA Updates SOPP 8001.4 on Proprietary Name Review for Biologics
FDA releases SOPP 8001.4 v9 on proprietary name review for biologics. Key implications for manufacturers and global regulatory strategy.
FDA Updates SOPP 8212 on Breakthrough Therapy Designation for Biologics
FDA updates SOPP 8212 on breakthrough therapy designation. Key changes in timelines, communication, and lifecycle management for manufacturers.
MHRA Updates Guidance on Clinical Investigations in Great Britain: Key Implications for Manufacturers
MHRA releases updated 2026 guidance on clinical investigations in Great Britain. Key regulatory impacts for medical device manufacturers under UK MDR.
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).