ENISA and CERT-EU Find Frontier AI Can Accelerate Security Code Review — but Human Validation Remains Essential
ENISA and CERT-EU tested frontier AI models on 27 open-source codebases, identifying 220 potential issues. Of 88 findings reviewed by code owners, 95% were confirmed as true positives, while human validation remained essential.
Swissmedic Extends Deadline for Publishing Officially Mandated Safety Information Materials
Swissmedic has extended the deadline to 31 December 2026 for publishing outstanding officially mandated safety information materials on its electronic publication platforms.
FDA Seeks Feedback on Benefit-Risk Evaluation for Autonomous and Remote Robotic Medical Devices
FDA has published a discussion paper on benefit-risk evaluation for robotic medical devices with autonomous or remote teleoperation capabilities, highlighting autonomy, connectivity, cybersecurity, human factors and postmarket oversight.
MHRA Updates Medical Device Registration Guidance for Great Britain and Northern Ireland
The MHRA has updated its medical device registration guidance, covering DORS, annual fees, EUDAMED requirements for Northern Ireland, UK Responsible Persons, importers and device registration changes.
European Commission M/575 Standardisation Request Remains Under Execution Through 2028
The European Commission’s M/575 standardisation request for MDR and IVDR remains under execution until 31 December 2028, with CEN and CENELEC supporting the development of harmonised standards for medical devices and IVDs.
European Commission Publishes New Harmonised Standards Decisions for MDR and IVDR
The European Commission has updated the harmonised standards framework for medical devices and IVDs with new implementing decisions under the MDR and IVDR published in November 2026.
FDA Finalizes Guidance on Validation of IVDs for Emerging Pathogens During Declared Emergencies
FDA has finalized guidance on validation of certain IVDs for emerging pathogens during Section 564 declared emergencies, covering clinical performance, LoD, inclusivity, usability, cybersecurity, change protocols and home and POC testing.
Swissmedic Launches 2027 Pilot for eCTD v4.0 Submissions
Swissmedic will introduce eCTD v4.0 through a pilot between January and April 2027, covering initial and follow-up submissions and based on the Swiss Implementation Guide v2.0.
Team-NB Calls for Targeted Reform of the MDR Clinical Evaluation Consultation Procedure
Team-NB has published a position paper on the MDR Clinical Evaluation Consultation Procedure, calling for greater predictability, transparency, proportionality and clearer clinical evidence expectations.
FDA Highlights 10 Years of Medical Device Cybersecurity Work
The FDA marks 10 years of its medical device cybersecurity team, highlighting its role in patient safety, vulnerability response and cybersecurity across the Total Product Life Cycle.
MHRA Updates Guidance on Clinical Investigations for Medical Devices
The MHRA has updated its guidance on medical device clinical investigations, including fee waivers for SMEs, application procedures, assessment timelines, SAE reporting, PMCF-related requirements and Northern Ireland rules.
EU Expert Panel Challenges Clinical Benefit Claims for Novel Class III Knee Osteoarthritis Device
A CECP expert panel has questioned the clinical benefit and promotional claims of a novel Class III intra-articular device for knee osteoarthritis, recommending stronger post-market evidence and revised PMCF activities.
October 2026 ISO Standards Update Highlights New Publications Across Medical Devices, Health Informatics and Cybersecurity
The October–November 2026 ISO standards update highlights new publications covering implants, dentistry, health informatics, telehealth cybersecurity, conformity assessment, AI security and data protection.
Team-NB Reports Strong Engagement with MDR/IVDR Safety Campaign
Team-NB reports more than 2,000 interactions with its MDR/IVDR LinkedIn safety campaign, highlighting stakeholder interest in patient safety, access, clinical evidence and regulatory simplification.
EU Expert Panel Raises Safety and Clinical Evidence Concerns for Novel Class III Ophthalmic Implant
A European CECP expert panel has raised concerns about insufficient safety and clinical performance data for a novel class III refillable ophthalmic implant and recommended additional focused clinical evidence.
Romania Outlines 2026 Medical Device Reimbursement Landscape and Future Access Priorities
AFPM’s 2026 overview of medical device reimbursement in Romania highlights current funding mechanisms, market access pathways, public procurement practices and future reforms including EU HTA, value-based procurement and reimbursement for high-value technologies.
MDCG Publishes New Guidance on Clinical Evidence for Orphan IVDs
MDCG 2026-6 introduces a dedicated framework for clinical evidence, PMPF, notified body assessment and expert panel involvement for orphan IVDs under the IVDR.
FDA Finalizes Guidance on Reducing the Risk of Transfusion-Transmitted Hepatitis B Virus
FDA has finalized guidance updating HBV testing recommendations for blood establishments, including discontinuation of HBsAg testing for certain donations when HBV NAT and anti-HBc testing are performed.
MDCG Updates Position on SSCP and SSP Management in EUDAMED
MDCG 2026-4 rev.1 clarifies the transition of SSCP and SSP uploads in EUDAMED from notified bodies to manufacturers, including new responsibilities and a 27 March 2027 deadline for certain legacy registrations.
Health Canada Updates MDEL Application Form and Guidance Ahead of December 2026 Changes
Health Canada has updated the Medical Device Establishment Licence application form FRM-0292 and guidance GUI-0016, introducing a new online submission process effective from 1 December 2026.