Medical Device News: May 2022 Regulatory Update

Below are all the topics we will discuss during this episode. Don’t miss the latest updates.

EU

• EUDAMED
  • EUDAMED & Certificate: https://ec.europa.eu/health/medical-devices-eudamed/notified-bodies-and-certificates-module_en
  • EUDAMED Notified Body User guide: https://ec.europa.eu/health/document/download/8b6132fd-75ed-4e8b-8be5-920725037221_en?filename=md_eudamed-nb-user-guide_en_0.pdf
  • EUDAMED Economic Operator User Guide: https://webgate.ec.europa.eu/eudamed-static/documents/assets/guides/user_guide_eo_en.pdf
• Delegated acts: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=COM:2022:182:FIN
• TURKEY: Reminder custom agreement: https://ec.europa.eu/health/latest-updates/notice-stakeholders-eu-turkey-customs-union-agreement-field-medical-devices-2022-04-13_en
• Spain: CCPS registration of IVD until EUDAMED is fully available: https://www.aemps.gob.es/informa/notasinformativas/productossanitarios/2022-ps/informacion-sobre-la-comunicacion-de-productos-sanitarios-de-diagnostico-in-vitro-en-ccps/

USA

• MDSAP Audit Approach: https://www.fda.gov/media/157861/download
• FDA: Refuse to accept Policy for 510k: https://www.fda.gov/media/83888/download
• FDA Medsun Newsletter: https://www.fda.gov/media/157448/download

MEA

• Ethiopia: Labelling requirements: http://www.fmhaca.gov.et/wp-content/uploads/2022/04/Guidelines-for-Medical-device-Labeling.pdf

ASIA

• Malaysia: Labelling requirements: https://www.mda.gov.my/documents/draft-guidance-documents/1969-attachment-1-public-comment-mda-gd0026-requirement-on-labelling-of-md/file.html

EVENT

• Medtech Forum: https://www.themedtechforum.eu/
• SFDA: Webinar Clinical Evaluation and PMCF: https://www.sfda.gov.sa/en/workshop/86686

GUIDANCES

• MDCG Subgroup development and deliverables – https://ec.europa.eu/health/system/files/2022-04/mdcg_ongoing_guidancedocs_en.pdf
• MDCG 2022-5 Borderline: https://ec.europa.eu/health/document/download/b5a27717-229f-4d7a-97b1-e1c7d819e579_en?filename=mdcg_2022-5_en_0.pdf
• WHO Guidance: PMS for MD and IVD. https://www.who.int/publications/i/item/9789240015319

NOTIFIED BODIES:

• IVDR: 3EC international. https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=notification.html&ntf_id=317359&version_no=3

Easy Medical Device Nostalgia:

• Episode 175: How to prepare an audit with Front Room Back Room: https://podcast.easymedicaldevice.com/175/
• Episode 176: How your PMCF is evaluated by a Notified Body with Matthias Fink from TÜV SÜD: https://podcast.easymedicaldevice.com/176/
• Episode 177: Training process with Rod Beuzeval and Katie Cooney from Trinzo and Meddev Solutions: https://podcast.easymedicaldevice.com/177/

The post Medical Device News: May 2022 Regulatory Update appeared first on Medical Device made Easy Podcast. Monir El Azzouzi