Medical Device News March 2026 Regulatory Update
Medboard
- Sponsor: Medboard: https://www.medboard.com/
Europe
- Pharmacist are distributors – French guide issued to educate them: https://medboard-public-assets.s3.amazonaws.com/Regulatory/9b892d08-611c-4326-a40e-750e0364df27.pdf
Team NB
- Team NB position Paper – Reduced Scrutiny, Cost saving: https://www.team-nb.org/wp-content/uploads/2026/03/Team-NB-PositionPaper-MDR-IVDR-revision-impact-on-the-sector-20260302.pdf
- Team-NB Demonstrate Safety and performance – For Combination of reagent and other equipment: https://www.team-nb.org/wp-content/uploads/2026/02/Team-NB-PositionPaper-Demonstration-of-Safety-and-Performance-for-Combinatorial-Use-of-Devices-or-Equipment-V1-20260216.pdf
- Team-NB- Letter on Cybersecurity – New Proposal again: https://www.team-nb.org/wp-content/uploads/2026/02/Team-NB-Letter-on-cybersecurity-20260205.pdf
- Team-NB – MDR Clinical & Tech File Training – Check the dates: https://medboard-public-assets.s3.amazonaws.com/Regulatory/442102-Leaflet-MDR-Clinical-Manufacturers-Training-20260528.pdf and https://www.team-nb.org/wp-content/uploads/2026/02/Leaflet-MDR-TD-Manufacturers-Training-20260429.pdf
UK
- Consultation on recognizing CE mark – Should it be indefinitely: https://www.gov.uk/government/consultations/medical-devices-regulations-targeted-consultation-on-the-indefinite-recognition-of-ce-marked-devices
- Consultation until: April 10, 2026
- UK Reliance is ongoing – Draft proposal to recognize MDSAP and other: https://www.gov.uk/government/publications/implementation-of-the-future-regulation-of-medical-devices/statement-of-policy-intent-international-recognition-of-medical-devices
- Bookmark the MHRA contact page -*Whispering* If you want to Whistleblow, there is a contact Chuuut!!!: https://www.gov.uk/guidance/contact-mhra
Solutions
- EasyIFU: For eifu and Label – Test it for Free: https://easyifu.com
- Smarteye: for eQMS . Ask for a Demo: https://eqms-smarteye.com/
RoW
- IMDRF
- Reliance Playbook – With examples to apply: https://www.imdrf.org/sites/default/files/2026-02/IMDRF%20GRRP%20WG%20N89%20Reliance%20Playbook.pdf
- USA
- FDA Cybersecurity documentation – Final Guidance: https://www.fda.gov/media/119933/download
- Malaysia
- Launch of the Innovative Pathway – Accelerate the development of your device: https://portal.mda.gov.my/index.php/announcement/1771-implementation-of-the-innovative-medical-device-review-pathway-by-medical-device-authority-ministry-of-health-malaysia
- Argentina
- Self Declaration expended for Low-Risk devices – Themis platform to be used: https://www.argentina.gob.ar/noticias/entra-en-vigencia-el-nuevo-regimen-simplificado-para-la-habilitacion-de-establecimientos
Podcast
- Episode 376 – Defect Management in SaMD with Anindya Mookerjea: https://podcast.easymedicaldevice.com/376-2/
- Episode 377 – IEC 60601 4th edition with Leo Eisner: https://podcast.easymedicaldevice.com/377-2/
- Episode 378 – IMDRF & Regulatory Reliance with Stephanie Grassmann: https://podcast.easymedicaldevice.com/378-2/
Social Media to follow
- Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
- Twitter: https://twitter.com/elazzouzim
- Pinterest: https://www.pinterest.com/easymedicaldevice
- Instagram: https://www.instagram.com/easymedicaldevice
