CMS Proposes New UDI Measure Under Medicare Interoperability Program
CMS proposes a new UDI measure requiring hospitals to attest use of EHR systems to capture implantable device UDIs, reinforcing FDA UDI system adoption.
MDCG Publishes Revision 2 of EMDN Guidance (MDCG 2021-12 Rev.2)
MDCG publishes Revision 2 of EMDN guidance, clarifying code assignment, updates, and EUDAMED requirements under MDR and IVDR.
ENISA Publishes National Capabilities Assessment Framework (NCAF) 2.0 – 2026 Edition
ENISA releases NCAF 2.0, a new framework to assess EU cybersecurity capabilities, aligned with NIS2, CRA and DORA, with focus on risk, supply chain and incident response.
MITRE Publishes White Paper on SBOM Data Normalization for Medical Device Manufacturers
MITRE releases a 2026 white paper on challenges and considerations in SBOM data normalization for medical device manufacturers.
Health Canada Ends Reconsideration Path for Priority Review and NOC/c Decisions
Health Canada eliminates reconsideration requests for priority review and NOC/c decisions from April 2026. Key regulatory impacts for drug sponsors explained.
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.