EU Batteries Regulation (EU) 2023/1542: Ongoing Implementation and Considerations for Manufacturers
Learn about EU Batteries Regulation (EU) 2023/1542, including key requirements, scope, and timeline. What manufacturers need to know for compliance from 2025 onwards.
MDCG 2026-1: EMDN Updates from 2025 Public Consultation Published
MDCG 2026-1 summarises accepted, partially accepted, and rejected EMDN updates from the 2025 public consultation and nomenclature working group.
EU Defines Conditions for Delaying Cybersecurity Notifications under the Cyber Resilience Act
EU Delegated Regulation 2026/881 defines when cybersecurity vulnerability and incident notifications may be delayed under the Cyber Resilience Act.
EU Borderline & Classification Manual (Version 5 – April 2026): What Manufacturers Need to Know
New EU Borderline & Classification Manual v5 (April 2026) published. Key MDR/IVDR qualification and classification examples for manufacturers.
MHRA Updates Guidance on Clinical Investigations and Introduces 2026–2027 Fee Waiver Pilot
MHRA updates its clinical investigations guidance and introduces a 2026–2027 fee waiver pilot for SMEs. Key requirements for medical device manufacturers explained.
MDCG Publishes Updated Guidance on Medical Device Classification (MDCG 2021-24 Rev.1)
MDCG updates medical device classification guidance under EU MDR. Key changes manufacturers must review for compliance and documentation.
MHRA aligns Declaration of Helsinki with UK Clinical Trial Regulations: What manufacturers need to know
MHRA clarifies alignment between the Declaration of Helsinki and amended UK Clinical Trial Regulations effective April 2026. Key impacts for sponsors and manufacturers.
MHRA Updates Guidance on Archiving and Retention of Clinical Trial Records
MHRA updates clinical trial record retention rules to 25 years. Key implications for manufacturers, TMF management, and UK regulatory compliance.
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FDA Issues Draft Guidance on NGS-Based Safety Assessment for Genome Editing Therapies
FDA releases draft guidance on next-generation sequencing (NGS) for genome editing safety assessment.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.