Medical Device News April 2025 Regulatory Update

Sponsor: Medboard

Europe

•  Certificates under Condition – Team NB press release: https://www.team-nb.org/wp-content/uploads/2025/03/PressRelease-WP3-Task3.3-Certificates-with-Conditions-20250312.pdf
• European Artificial Intelligence Office -A new expert panel for AI Medical Devices:  https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202500454

• UK invented the AIaMD – Fewer law but more guidance: https://www.gov.uk/government/publications/the-regulation-of-artificial-intelligence-as-a-medical-device-government-response-to-the-rhc/the-regulation-of-artificial-intelligence-as-a-medical-device-government-response-to-the-regulatory-horizons-council
• Submit a Clinical Study in Spain and Belgium – Each country decides:
  • Spain: https://www.aemps.gob.es/informa/la-aemps-detalla-el-procedimiento-para-la-publicacion-de-informes-de-investigaciones-clinicas-con-productos-sanitarios-en-espana/
  • Belgium: https://www.afmps.be/sites/default/files/Guideline%20Submission%20of%20Clinical%20Investigation%20according%20to%20MDR_version%2011.0_0.pdf
• SCHEER – Brain Stimulators – Non-medical purpose use: https://health.ec.europa.eu/latest-updates/scheer-minutes-working-group-meeting-brain-stimulators-19-march-2025-2025-03-28_en
• IMDRF Reliance Program – For Regulators but can impact manufacturers: https://www.imdrf.org/sites/default/files/2025-03/IMDRF%20Reliance%20playbook%20draft%20%28final%29.pdf
• Successful Pilot Advice Expert Panel – For high-risk device: https://www.ema.europa.eu/en/documents/report/pilot-advice-expert-panels-manufacturers-high-risk-medical-devices-interim-report-experience-pilot-february-2023-december-2024_en.pdf
• Team NB MDR Clinical Training – May 7th 2025: https://www.team-nb.org/wp-content/uploads/2025/03/Leaflet-MDR-Clinical-Manufacturers-Training-20250507.pdf

Registration

• Ask Easy Medical Device for Registration – Support most of the world: https://easymedicaldevice.com

ROW

• Sex Specific Data in Clinical Study – Do it or?: https://www.fda.gov/media/82005/download
• Brazil UDI in Progress – Subtitle: Anvisa consultation is open: https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2025/anvisa-abre-consulta-publica-sobre-base-de-dados-para-identificacao-unica-de-dispositivos-medicos
• Become a Conformity Assessment Body in Malaysia – Notified Body are not automatically Conformity assessment bodies: https://www.mda.gov.my/images/DOC%20UPLOAD/DOC%20UPLOAD%202025/Guidance%20Document%20Conformity%20Assessment%20Body%20CAB%20Guide%20for%20Conducting%20Conformity%20Assessment%20By%20Way%20of%20Verification.pdf
• Saudi Arabia ISO 13485 guidance -Looks like an MDSAP structure: https://www.sfda.gov.sa/sites/default/files/2025-03/MDS-G024.pdf
• Singapore Cybersecurity Best Practice – Consultation until May 12, 2025: https://www.hsa.gov.sg/docs/default-source/hprg-mdb/regulatory-updates/best-practices-guide-on-medical-device-cybersecurity_draft-for-consultation.pdf?sfvrsn=8dcfa560_1

Podcast

• Episode 328 – What are the TOP 3 FDA inspection issues with Darrin Carlson: https://podcast.easymedicaldevice.com/328-2/
• Episode 329 – What if the Notified Body asks you: Is your Software Validated?: https://podcast.easymedicaldevice.com/329-2/

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

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