MDN News Collection
Regulatory news items selected in MDN – Medical Device News, organized by date, source, thematic area, and scope. Use the search function to quickly find the updates that interest you.
| Date | News title | Source | Thematic area | Scope | MDN issue |
|---|---|---|---|---|---|
| 25/09/2026 | WHO expands prequalification programme for medical devices | WHO | Prequalification / medical devices | WHO / Medical devices | MDN #018 - News 1 |
| 25/09/2026 | FDA issues draft guidance on premarket submissions for robotically-assisted surgical devices | FDA | Premarket submissions / robotically-assisted surgical devices | FDA / Medical devices / surgical devices | MDN #018 - News 2 |
| 23/09/2026 | FDA advisory panel reviews PMA for Galleri multi-cancer detection IVD | FDA | IVD / multi-cancer detection / advisory panel | FDA / IVD / oncology | MDN #018 - News 3 |
| 23/09/2026 | European Commission opens new Joint Scientific Consultation request period | European Commission / HTACG | Health technology assessment / Joint Scientific Consultations | EU HTA / Medical devices / IVD | MDN #018 - News 4 |
| 22/09/2026 | EU publishes CECP expert decision and opinion on Class III orthopaedic device | European Commission / Medical Device Expert Panels | Clinical evaluation / CECP / expert panels | MDR / Class III medical devices / CECP | MDN #018 - News 5 |
| 17/09/2026 | FDA denies 510(k) exemption for radiology CAD and triage software | FDA | Radiology software / CAD and triage | FDA / Medical devices / software | MDN #017 - News 1 |
| 17/09/2026 | FDA issues draft guidance on electronic submission template for PMAs | FDA / CDRH / CBER | Electronic submissions / PMA templates | FDA / Medical devices / PMA | MDN #017 - News 2 |
| 17/09/2026 | MHRA highlights RF safety risks in wireless CTG monitoring systems | MHRA | Safety communications / wireless CTG | UK / Medical devices | MDN #017 - News 3 |
| 18/09/2026 | ISO publishes ISO 11607-3 on requirements for process development for forming, sealing and assembly of sterile medical-device packaging | ISO | Standards / sterile packaging | Medical devices / sterile barrier systems | MDN #017 - News 4 |
| 15/09/2026 | Health Canada updates compliance and enforcement policy for health products | Health Canada | Compliance and enforcement | Canada / Medical devices / health products | MDN #017 - News 5 |
| 09/09/2026 | MDCG updates guidance on IVDR classification rules | MDCG | IVDR classification / quality-control materials | IVDR / IVD | MDN #016 - News 1 |
| 10/09/2026 | UK National Commission presents recommendations for the regulation of AI in healthcare | MHRA / National Commission into the Regulation of AI in Healthcare | AI / healthcare regulation | UK / Medical devices / AI | MDN #016 - News 2 |
| 10/09/2026 | Swissmedic publishes GPMV-IVD guideline on IVD materiovigilance | Swissmedic | IVD materiovigilance | Switzerland / IVD | MDN #016 - News 3 |
| 11/09/2026 | FDA codifies Class II classification for cardiovascular machine learning-based notification software | FDA / Federal Register | Software / cardiovascular machine learning | FDA / Medical devices / AI | MDN #016 - News 4 |
| 11/09/2026 | FDA posts Class I recall for Nova Biomedical StatStrip glucose and ketone meter | FDA / CDRH | Recalls / hospital glucose and ketone meters | FDA / IVD / near-patient testing | MDN #016 - News 5 |
| 01/09/2026 | MHRA announces regulatory reform amendments in the Government’s Health Bill | MHRA | UK regulatory reform / medical-device licensing | UK / Medical devices | MDN #015 - News 1 |
| 01/09/2026 | EMA opens Phase Ib of breakthrough medical-device pilot | EMA | Breakthrough devices / expert-panel support | EU / Medical devices | MDN #015 - News 2 |
| 01/09/2026 | EU-funded DIGICAP project launches for MDR/IVDR conformity assessment digitalisation | Team-NB / European Commission CORDIS | Conformity assessment digitalisation | MDR / IVDR | MDN #015 - News 3 |
| 03/09/2026 | FDA identifies Boston Scientific Infinion CX Lead recall as most serious type | FDA / CDRH | Recalls / spinal cord stimulation | FDA / Medical devices / neurostimulation | MDN #015 - News 4 |
| 02/09/2026 | MHRA advises use of filters during parenteral nutrition administration | MHRA | Safety communications / parenteral nutrition | UK / Medical devices | MDN #015 - News 5 |
| 06/08/2026 | IMDRF publishes essential principles for Predetermined Change Control Plans | IMDRF | Software / predetermined change control plans | Medical device software | MDN #014 - News 1 |
| 03/08/2026 | FDA updates human factors and usability engineering guidance | FDA / CDRH | Human factors / usability engineering | FDA / Medical devices | MDN #014 - News 2 |
| 06/08/2026 | Team-NB publishes a position paper on transparency in the context of the proposed revision of the MDR and IVDR Regulations | Team-NB | MDR/IVDR revision / transparency | MDR / IVDR | MDN #014 - News 3 |
| 10/08/2026 | MHRA issues notice over devices supplied without valid UKCA or CE markings | MHRA | Market surveillance / conformity markings | UK / Medical devices | MDN #014 - News 4 |
| 17/08/2026 | FDA reclassifies certain oncology-related ISH test systems to Class II | FDA / Federal Register | IVD classification / oncology diagnostics | FDA / IVD | MDN #014 - News 5 |
| 18/08/2026 | FDA opens discussion on regulation of generative AI-enabled medical devices | FDA / CDRH | AI / generative AI-enabled devices | FDA / Medical devices / AI | MDN #014 - News 6 |
| 18/08/2026 | EMA updates consultation procedure for ancillary medicinal substances in medical devices | EMA | Ancillary medicinal substances / EMA consultation | EU / Medical devices | MDN #014 - News 7 |
| 24/08/2026 | FDA publishes Recognition List 066 for consensus standards | FDA / CDRH | Consensus standards / recognized standards | FDA / Medical devices | MDN #014 - News 8 |
| 06/08/2026 | ISO publishes updated ISO 10993-3 | ISO | Biological evaluation / ISO 10993 | Medical devices / standards | MDN #014 - News 9 |
| 26/08/2026 | MHRA highlights metal-wear risks in cobalt-chrome modular-neck hip replacements | MHRA | Safety communications / hip replacements | UK / Medical devices | MDN #014 - News 10 |
| 29/07/2026 | MHRA issues guidance on ambient voice technology and updates digital mental health guidance | MHRA | Software qualification / digital health | UK / Medical devices / software | MDN #013 - News 1 |
| 27/07/2026 | EU Court of Justice clarifies MDR due-care obligations for distributors | Court of Justice of the European Union | Distributors / due-care obligations | MDR | MDN #013 - News 2 |
| 30/07/2026 | FDA publishes medical-device user fees for FY 2027 | FDA / Federal Register | User fees | FDA / Medical devices | MDN #013 - News 3 |
| 27/07/2026 | GORE updates safety information for the EXCLUDER TAMBE device | Italian Ministry of Health / W. L. Gore & Associates | Field safety notice / endoprosthesis | Medical devices / vascular devices | MDN #013 - News 4 |
| 30/07/2026 | MHRA publishes fifth edition of MRI safety guidelines | MHRA | MRI safety / clinical use | UK / Medical devices | MDN #013 - News 5 |
| 22/07/2026 | MDCG clarifies UDI assignment between manufacturers and distributors | MDCG | UDI / traceability | MDR | MDN #012 - News 1 |
| 22/07/2026 | Italian Ministry of Health updates process for reporting medical device and IVD complaints | Italian Ministry of Health | Complaints / reporting | Italy / Medical devices / IVD | MDN #012 - News 2 |
| 23/07/2026 | WHO announces first interim list of medical device regulatory authorities | WHO | Regulatory reliance / WHO Listed Authorities | Medical devices / regulatory authorities | MDN #012 - News 3 |
| 22/07/2026 | EN 18286:2026 - “Artificial intelligence — Quality management system for EU AI Act regulatory purposes” | CEN | AI / quality management | EU AI Act / medical devices | MDN #012 - News 4 |
| 24/07/2026 | FDA issues Early Alert for Boston Scientific ENROUTE Transcarotid Neuroprotection Systems | FDA / CDRH | Safety communications / neuroprotection systems | FDA / Medical devices | MDN #012 - News 5 |
| 14/07/2026 | European Commission publishes version 3.5 of medical device availability dashboard | European Commission | Device availability / conformity assessment | EU / Medical devices | MDN #011 - News 1 |
| 13/07/2026 | European Commission updates notified-body standard-fee list | European Commission | Notified bodies / standard fees | MDR / IVDR | MDN #011 - News 2 |
| 14/07/2026 | MHRA updates guidance on point-of-care IVD devices | MHRA | IVD / point-of-care testing | UK / IVD | MDN #011 - News 3 |
| 14/07/2026 | FDA requests input on certain non-device software functions | FDA / CDRH | Software / non-device functions | FDA / Software functions | MDN #011 - News 4 |
| 15/07/2026 | FDA issues Early Alert for ResMed Astral ventilators | FDA / CDRH | Safety communications / ventilators | FDA / Medical devices | MDN #011 - News 5 |
| 08/07/2026 | Council of Europe publishes follow-up position paper on MDR implementation in the substances of human origin sector | Council of Europe / EDQM | MDR / substances of human origin | MDR / SoHO sector | MDN #010 - News 1 |
| 07/07/2026 | FDA announces public meeting and comment process for Medical Device User Fee Amendments (MDUFA VI) | FDA / CDRH / Federal Register | User fees / MDUFA | FDA / Medical devices | MDN #010 - News 2 |
| 08/07/2026 | Swissmedic updates information sheet on performance studies with IVDs | Swissmedic | IVD performance studies | Switzerland / IVD | MDN #010 - News 3 |
| 07/07/2026 | FDA identifies Ivenix Large Volume Infusion Pump corrections as Class I recall | FDA / CDRH | Recalls / infusion pumps | FDA / Medical devices | MDN #010 - News 4 |
| 06/07/2026 | ISO starts revision of ISO/TR 24971:2020 and registers new ISO/TS 24971-1 project | ISO | Risk management / ISO 14971 | Medical devices / standards | MDN #010 - News 5 |
| 29/06/2026 | European Commission publishes delegated acts on well-established technologies under the MDR | European Commission / Official Journal of the European Union | Well-established technologies | MDR | MDN #009 - News 1 |
| 01/07/2026 | Team-NB proposes risk-adaptive surveillance systems under the MDR and IVDR | Team-NB | Risk-adaptive surveillance | MDR / IVDR | MDN #009 - News 2 |
| 01/07/2026 | Swissmedic confirms mandatory device registration in swissdamed from 1 July 2026 | Swissmedic | Device registration / swissdamed | Switzerland / Medical devices / IVD | MDN #009 - News 3 |
| 29/06/2026 | MHRA updates Great Britain guidance on borderlines with medical devices | MHRA | Borderline products | UK / Medical devices / medicinal products | MDN #009 - News 4 |
| 01/07/2026 | FDA expands TAP Pilot across all Offices of Health Technologies | FDA / CDRH | TAP Pilot / early engagement | FDA / Medical devices | MDN #009 - News 5 |
| 26/06/2026 | ESMINT-led consensus addresses clinical evidence standards for high-risk endovascular stroke devices | ESMINT / Team-NB | Clinical evidence / stroke devices | MDR | MDN #008 - News 1 |
| 25/06/2026 | FDA posts data integrity notifications for medical device submissions | FDA / CDRH | Data integrity | FDA / Medical devices | MDN #008 - News 2 |
| 26/06/2026 | MHRA extends annual medical device registration fee deadline | MHRA | Registration / fees | UK / Medical devices / IVD | MDN #008 - News 3 |
| 26/06/2026 | FDA classifies preeclampsia prognostic test into class II | FDA / Federal Register | IVD classification | FDA / IVD | MDN #008 - News 4 |
| 24/06/2026 | European Commission publishes EU HTA flash report from HTACG meeting | European Commission | EU HTA / joint clinical assessment | EU HTA / Medical devices / IVD | MDN #008 - News 5 |
| 17/06/2026 | European Commission updates harmonised standards references under the MDR and IVDR | European Commission / Official Journal of the European Union | Harmonised standards | MDR / IVDR | MDN #007 - News 1 |
| 18/06/2026 | MDCG publishes transitional arrangements for the management of SS(C)P in EUDAMED | Medical Device Coordination Group | EUDAMED | MDR / IVDR | MDN #007 - News 2 |
| 17/06/2026 | MDCG provides guidance on the transition to the “EU REP” symbol | Medical Device Coordination Group | Labelling / symbols | MDR / IVDR | MDN #007 - News 3 |
| 17/06/2026 | FDA classifies machine learning-based imaging software with a PCCP into class II | FDA / Federal Register | Software / AI | FDA | MDN #007 - News 4 |
| 17/06/2026 | FDA classifies ingestible gastrointestinal blood detection capsules into class II | FDA / Federal Register | Gastrointestinal diagnostics | FDA | MDN #007 - News 5 |
| 10/06/2026 | Team-NB publishes IVDR application and surveillance transfer agreement template | Team-NB | IVDR transition | IVDR | MDN #006 - News 1 |
| 11/06/2026 | FDA classifies two IVD device types into class II with special controls | FDA / Federal Register | IVD classification | FDA / IVD | MDN #006 - News 2 |
| 08/06/2026 | FDA issues Early Alert on Hamilton Medical breathing circuit sets | FDA / CDRH | Safety communications | FDA / Medical devices | MDN #006 - News 3 |
| 11/06/2026 | FDA issues Early Alert on Baxter Volara System patient circuits | FDA / CDRH | Safety communications | FDA / Medical devices | MDN #006 - News 5 |
| 11/06/2026 | FDA identifies Abiomed Automated Impella Controllers correction as the most serious type of recall | FDA / CDRH | Recalls / corrections | FDA / Medical devices | MDN #006 - News 4 |
| 04/06/2026 | Team-NB publishes Version 2 of its MDR certification process consensus document | Team-NB | MDR certification | MDR | MDN #005 - News 1 |
| 05/06/2026 | FDA announces updated guidance on premarket notification exemptions for certain unclassified devices | FDA / CDRH / Federal Register | 510(k) / Premarket notification | FDA | MDN #005 - News 2 |
| 01/06/2026 | ISO publishes the June 2026 ISO Update | ISO | Technical standardisation | MDR / IVDR / IVD / Medical devices | MDN #005 - News 3 |
| 02/06/2026 | FDA issues Early Alert on Abiomed catheter introducer kits | FDA / CDRH | Safety communications | FDA / Medical devices | MDN #005 - News 4 |
| 05/06/2026 | FDA issues Early Alert on GE HealthCare infant resuscitation systems | FDA / CDRH | Safety communications | FDA / Medical devices | MDN #005 - News 5 |
| 28/05/2026 | EUDAMED: first four modules become mandatory from 28 May 2026 | European Commission / DG SANTE | EUDAMED | MDR / IVDR | MDN #004 - News 1 |
| 26/05/2026 | Team-NB publishes legal expert opinion on MDR Article 50 | Team-NB | MDR / Notified bodies | MDR | MDN #004 - News 2 |
| 27/05/2026 | FDA issues Early Alert on certain ICU Medical IV tubing sets | FDA / CDRH | Safety communications | FDA / Medical devices | MDN #004 - News 3 |
| 29/05/2026 | FDA updates medical device safety notices and recall listings | FDA / Medical Device Safety | Recalls / safety alerts | FDA / Medical devices | MDN #004 - News 4 |
| 25/05/2026 | FDA recognizes ISO 10993-1:2025 | FDA / Recognized Consensus Standards Database | Recognized standards / biocompatibility | FDA / Medical devices | MDN #004 - News 5 |
| 05/05/2026 | European Commission highlights Implementing Regulation (EU) 2026/977 on notified body conformity assessment activities | European Commission / DG SANTE | Notified bodies / conformity assessment | MDR / IVDR | MDN #003 - News 1 |
| 22/05/2026 | Italy issues updated operational communication on MIR 7.3.1 submissions through Dispovigilance | Italian Ministry of Health / DGDMF | Vigilance / incident reporting | Italy / MDR / IVDR | MDN #003 - News 2 |
| 21/05/2026 | FDA Early Alert: Abiomed Automated Impella Controllers affected by software restart issue | FDA / CDRH | Safety communications | FDA / Medical devices | MDN #003 - News 3 |
| 21/05/2026 | FDA recall: React Health VOCSN V+Pro ventilators | FDA / CDRH | Recalls / respiratory devices | FDA / Medical devices | MDN #003 - News 4 |
| 20/05/2026 | FDA Class I recall update: Bolton Medical Relay Pro thoracic stent graft system | FDA / CDRH | Recalls / cardiovascular devices | FDA / Medical devices | MDN #003 - News 5 |
| 06/05/2026 | FDA Early Alert: Draeger Atlan A350 / A350 XL anesthesia workstations | FDA / CDRH | Safety communications | FDA / Medical devices | MDN #002 - News 1 |
| 13/03/2026 | FDA Class I recall: AVID Medical convenience kits containing Namic RA syringes | FDA / CDRH | Recalls / angiographic devices | FDA / Medical devices | MDN #002 - News 2 |
| 15/05/2026 | Italy: Ministry of Health recall notice for NAMIC ANGIOGRAPHIC CONTROL SYRINGE | Italian Ministry of Health | Vigilance / recalls | Italy / Medical devices | MDN #002 - News 3 |
| 12/05/2026 | Italy: Ministry of Health safety information notice for SCHILLER FRED EASY G2 DA | Italian Ministry of Health | Vigilance / safety notices | Italy / Medical devices | MDN #002 - News 4 |
| 12/05/2026 | Italy: Ministry of Health recall notice for ADHESE 2 VIVAPEN kit and cannulas | Italian Ministry of Health | Vigilance / recalls | Italy / Medical devices | MDN #002 - News 5 |
| 05/05/2026 | Commission Implementing Regulation (EU) 2026/977 published | European Commission / EUR-Lex | Notified bodies / conformity assessment | MDR / IVDR | MDN #001 - News 1 |
| 07/05/2026 | EU updates MIR 7.3.1 PDF and clarifies accepted versions from 1 May 2026 | European Commission / DG SANTE | Vigilance / incident reporting | MDR / IVDR | MDN #001 - News 2 |
| 07/05/2026 | FDA updates safety communication on Boston Scientific ACCOLADE pacemakers | FDA / CDRH | Safety communications | FDA / Medical devices | MDN #001 - News 3 |
| 06/05/2026 | FDA publishes final guidance on patient-matched guides for orthopedic implants | FDA / CDRH | Orthopedic devices / premarket submissions | FDA | MDN #001 - News 4 |
| 05/05/2026 | FDA updates Class I recall communication for Intuitive Surgical SureForm 30 Gray Reloads | FDA / CDRH | Recalls / surgical devices | FDA / Medical devices | MDN #001 - News 5 |