Medical Device News APRIL 2026 Regulatory Update
Medboard
- Sponsor: Medboard: https://www.medboard.com/
EU
- Extension of WET Class Iib – A new list with new products mentioned: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=PI_COM:C(2026)1809
- Update your MIR form – Version 7.3.1: https://health.ec.europa.eu/document/download/e8ce9f53-82cb-44c8-a06e-91ad71c16b01_en?filename=md_new-reg_mir-form-v7.3.1_en.pdf
UK
- Future Regulation -Implementation: https://www.gov.uk/government/publications/implementation-of-the-future-regulation-of-medical-devices/implementation-of-the-future-regulations
- Consultation on indefinite recognition of CE marked medical devices and current transitional arrangements
- Pre-market Statutory Instrument (SI)
- Future Enhancemens: Exceptional Use Authorization and Health Institution exemption
- Post-market Surveillance Requirements
- Update to guidances
- Learn Clinical Investigation in the UK – Lot of questions answered:
- Clinical investigations for electrically powered devices : https://www.gov.uk/government/publications/clinical-investigations-for-electrically-powered-devices/clinical-investigations-for-electrically-powered-devices
- Clinical investigations: investigators’ responsibilities : https://www.gov.uk/government/publications/clinical-investigations-investigators-responsibilities/guidance-for-clincal-investigators
- Clinical investigations: statistical considerations : https://www.gov.uk/government/publications/clinical-investigations-statistical-considerations/statistical-considerations
- Medical devices that need a clinical investigation: https://www.gov.uk/government/publications/medical-devices-that-need-a-clinical-investigation
- Determining if Clinical Investigation is required: https://www.gov.uk/government/publications/medical-devices-that-need-a-clinical-investigation/determining-if-a-clinical-investigations-is-required
- Clinical Investigation Flow chart: https://assets.publishing.service.gov.uk/media/696f850b5b6060ca6736a0ae/flow_chart_for_clinical_investigations_v3.png
Events
- Team NB: Training IVDR -July 2nd 2026: https://www.team-nb.org/wp-content/uploads/2026/03/Leaflet-IVD-TD-Manufacturers-Training-20260702.pdf
- Egypt: Vigilance reporting Training – April 7 to 9, 2026: https://tinyurl.com/emdpodcast
- MedtechConf.com – Check the MAP
- EU
- Swiss Medtech Day 2026 – June 10, 2026: https://medtechconf.com/event/why-swiss-medtech-day-matters-what-you-should-know/
- Medtech Forum – May 11, 2026: https://medtechconf.com/event/the-medtech-forum-2026-shaping-the-future-of-medical-technology-in-europe/
- US
- Veeva Medtech US Summit- May 11. 2026: https://medtechconf.com/event/veeva-medtech-us-summit-2026-innovation-data-modernization-in-medical-devices/
- Brazil
- EU
RoW
- Australia: Software Advertisment -What to say: https://www.tga.gov.au/resources/guidance/advertising-software-based-medical-devices-australia
Your advertisement must contain:
- an accurate description of the device
- the trade name of the device
- the intended purpose(s) of the device
- any mandatory statements and, where relevant, health warnings.
For example, you must not:
- claim your product is “TGA approved”
- make unsubstantiated claims about the product’s performance
- include endorsements or testimonials from health professionals or medical researchers.
- Malaysia: Guidance Creation/Update – Medical Device Act 2012
- Guidance on Definition of Medical Devices: https://portal.mda.gov.my/index.php/announcement/1777-publication-of-second-edition-of-guidance-document-on-definition-of-medical-devices
- Guidance on confirmation of obsolete and discontinued medical device: https://portal.mda.gov.my/index.php/announcement/1778-publication-of-first-edition-of-guidance-document-on-application-for-confirmation-status-of-obsolete-and-discontinued-medical-devices
- Guidance on import and/or supply of unregistered medical devices under special access exemption application: https://portal.mda.gov.my/index.php/announcement/1779-publication-of-third-edition-of-guidance-document-on-import-and-or-supply-of-unregistered-medical-devices-under-special-access-exemption-application
- India: FAQ on IVD products – 24 questions with answers: https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/Addendum-Doc-No-CDSCOIVDFAQ-042022dated-13032026.pdf
- Egypt: What you need to register – List of documents: https://tinyurl.com/EmdEgyptRegistration
Podcast
- Podcast Nostalgia -Let’s remember: https://podcast.easymedicaldevice.com/
- Episode 381: EUDAMED deadline 2026: https://podcast.easymedicaldevice.com/381-2/
- Episode 382: Best-of of 3 podcasts: https://podcast.easymedicaldevice.com/382-2/
Service
- New Website: https://easymedicaldevice.com
- Authorized Representative
- Consulting
- Training
- EasyIFU: https://easyifu.com
- Smarteye: https://eqms-smarteye.com/
