Anvisa Publishes Manual on Notification of Risk Class I and II Medical Devices
Anvisa has published a manual on the notification process for risk class I and II medical devices in Brazil, covering company regularization, product classification, Solicita electronic submission, documentation requirements and secondary petitions.
European Commission Launches Survey on Electronic Instructions for Use for Medical Devices
The European Commission is considering allowing electronic instructions for use for all professional-use medical devices and has launched a survey for healthcare professionals and healthcare institutions in the EU.
FDA Publishes Discussion Paper on Regulation of Generative AI-Enabled Medical Devices
FDA has published a discussion paper seeking stakeholder feedback on regulatory considerations for generative AI-enabled medical devices, including risk assessment, premarket evaluation, benchmarking, clinical confirmation, postmarket monitoring and foundation models.
FDA Issues Draft Guidance on Potency Assessment of Active Immunotherapy Products
FDA has issued draft guidance on potency assessment of active immunotherapy products, covering potency assays, critical quality attributes, bioassays, physicochemical assays and product-specific considerations.
EMA Updates Q&A on Companion Diagnostics Consultation Procedure for Notified Bodies
EMA has updated its Q&A on practical arrangements for the companion diagnostics consultation procedure by notified bodies, covering letters of intent, IRIS submissions, rapporteur appointment, pre-submission interactions, eSubmission and fees.
Swissmedic Updates Technical Interpretation on Container-Specific Identity Guarantee of Starting Materials
Swissmedic has published version 6.0 of its technical interpretation on the container-specific guarantee of starting material identity, defining requirements for suppliers, GMP controls, labelling, certificates of analysis and inspections.
MHRA-NICE Real-World Evidence Scientific Dialogue Opens to Medical Device Applications
The MHRA-NICE Real-World Evidence Scientific Dialogue will now accept applications relating to real-world evidence and medical devices, with Approved Bodies represented in relevant workshops.
ISO 10993-3:2026 Published for Biological Evaluation of Medical Devices
ISO 10993-3:2026 has been published, updating guidance for the evaluation of genotoxicity, carcinogenicity, reproductive toxicity and developmental toxicity in the biological evaluation of medical devices.
Team-NB Calls for Balanced MDR/IVDR Revision Focused on Patient Safety
Team-NB, TÜV Verband and TIC Council highlight the importance of maintaining strict, risk-based oversight in the MDR/IVDR revision to protect patient safety.
Anvisa Introduces Electronic Registration for International Manufacturers of Risk Class I and II Medical Devices
Anvisa has announced that registration requests for international manufacturers of risk class I and II medical devices, including IVDs, must now be submitted electronically through the Solicita system using subject code 80326.
MHRA Publishes 2026 Safety Guidelines for MRI Equipment in Clinical Use
MHRA has published the fifth edition of its safety guidelines for MRI equipment in clinical use, covering MRI hazards, exposure management, governance, controlled access, patient management, equipment lifecycle, incidents and staff training.
EMA Holds Multistakeholder Workshop on Innovation in Cardiovascular Medicines and Medical Devices
EMA held a multistakeholder workshop on supporting innovation in cardiovascular medicines and medical devices in the EU, covering unmet needs, regulatory science, AI, digital technologies and emerging therapies.
Swissmedic Updates Information Sheet on Procurement of Medical Devices in Healthcare Institutions
Swissmedic has updated its information sheet on procurement of medical devices in healthcare institutions, covering conformity evidence, swissdamed registration, CH-REP and importer information, UDI, implant cards and non-conforming devices.
TGA Opens Consultation on Improving Information Sharing About Medical Devices
The TGA has opened a consultation on proposals to improve public information sharing about the safety, quality and performance of medical devices after post-market reviews or investigations.
Leveraging MDSAP to Strengthen MDR Quality Management and Audit Readiness
A regulatory affairs review highlights how MDSAP methodology can help French and EU medical device manufacturers structure quality management, internal audits and conformity control under the EU MDR.
EU Commission NB Survey Shows MDR Applications Slightly Decline While IVDR Applications Continue to Grow
The EU Commission 20th Notified Body Survey shows a slight decline in MDR applications and continued growth in IVDR applications, highlighting ongoing certification pressures under the MDR and IVDR.
MHRA Updates Guidance on Submitting Clinical Investigation Proposals for Assessment
MHRA has updated its guidance on submitting clinical investigation proposals, covering GB and Northern Ireland requirements, IRAS submission, supporting documentation, fees, device evidence, software, biological safety and sterilisation.
FDA Issues Updated Guidance on 510(k) Submissions for Hemodialysis Blood Tubing Sets
FDA has issued updated guidance on 510(k) submissions for hemodialysis blood tubing sets, covering device description, performance testing, biocompatibility, sterility, shelf life, packaging and labeling.
IMDRF Publishes Final Document on Predetermined Change Control Plans for Medical Device Software
IMDRF has published final principles on Predetermined Change Control Plans for medical device software, covering PCCP elements, risk-based change control, impact assessment, benefits and challenges.
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Team-NB Calls for Greater Transparency and EUDAMED Access for Notified Bodies
Team-NB has published a position paper calling for broader notified body access to EUDAMED and related regulatory systems to support risk-based surveillance under the MDR and IVDR.