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.
MedTech Europe Publishes 2026 Facts & Figures on the European Medical Technology Industry
MedTech Europe’s 2026 Facts & Figures report shows record employment and patent activity but slower market growth, declining global share and growing regulatory pressure on Europe’s medical technology sector.
ISO/TC 215 Publishes White Paper on Healthcare-Specific Considerations for AI
ISO/TC 215 has published a white paper examining how healthcare context changes the interpretation of AI principles including safety, fairness, transparency, human oversight, accountability and data governance.
Swissmedic Updates Medical Device Registration Fee Guidance for swissdamed
Swissmedic has updated its guidance on medical device registration fees in swissdamed, clarifying fee calculation, invoicing, legacy device transitions and payment requirements.
Swissmedic Updates Economic Operator Obligations for Medical Devices and IVDs
Swissmedic has updated its guidance on economic operator obligations for medical devices and IVDs in Switzerland, including new swissdamed registration requirements for importers.
Swissmedic Publishes Swiss Implementation Guide v2.0 for eCTD v4.0
Swissmedic has published version 2.0 of its Swiss Implementation Guide package for eCTD v4.0, including updated implementation guidance, controlled vocabulary and validation criteria ahead of the planned 2027 go-live.
Swissmedic Updates Guidance on Products Without an Intended Medical Purpose
Swissmedic has updated its guidance on products without an intended medical purpose, clarifying transitional provisions, conformity assessment, registration and economic operator obligations under the Swiss MedDO.
Anvisa Publishes Recognized Technical Standards for Medical Devices
Anvisa has published lists of recognized technical standards for medical devices, supporting product development, technical dossiers and demonstration of compliance with safety and performance requirements in Brazil.
UK Moves to Indefinitely Recognise CE-Marked Medical Devices and IVDs in Great Britain
MedTech Europe, ABHI and BIVDA have welcomed the UK Government’s decision to indefinitely recognise CE-marked medical devices and IVDs in Great Britain.
Anvisa Opens Consultation on Possible Expansion of MDSAP in Brazil
Anvisa has opened a targeted consultation to gather industry input on the possible expansion of the Medical Device Single Audit Program (MDSAP) in Brazil. Contributions are open until 9 November 2026.
IMDRF Opens Call for Training Providers for New Endorsement Model Pilot
IMDRF has opened a call for Expressions of Interest from external organisations to participate as training providers in its Training Endorsement Model Pilot, with initial activities planned for Brazil in September 2027.
FDA Expands PCCP Transparency for Future Medical Device Changes
FDA has published expanded information on Predetermined Change Control Plans, including PCCP structure, eligible submission pathways and a public list of authorized devices with PCCPs.
EMA Updates CECP Expert Panel Opinion List for High-Risk Medical Devices
EMA has updated its list of CECP Expert Panel opinions for high-risk medical devices undergoing conformity assessment, including a new Class III circulatory system device opinion issued in October 2026.
European Stakeholders Call for a Single Regulatory Pathway for AI-Enabled Medical Technologies
European healthcare and industry organisations are calling for AI-enabled medical devices and diagnostics to be regulated through a single MDR/IVDR pathway integrating relevant AI Act requirements.