Medical Device News: May 2022 Regulatory Update

In this episode, we will review all the changes related to Quality & Regulatory Affairs for Medical Devices in the month of May 2022.

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

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

EU

EUDAMEDEUDAMED & Certificate: https://ec.europa.eu/health/medical-devices-eudamed/notified-bodies-and-certificates-module_enEUDAMED 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.pdfEUDAMED Economic Operator User Guide: https://webgate.ec.europa.eu/eudamed-static/documents/assets/guides/user_guide_eo_en.pdfDelegated acts: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=COM:2022:182:FINTURKEY: Reminder custom agreement: https://ec.europa.eu/health/latest-updates/notice-stakeholders-eu-turkey-customs-union-agreement-field-medical-devices-2022-04-13_enSpain: 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/downloadFDA: Refuse to accept Policy for 510k: https://www.fda.gov/media/83888/downloadFDA 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.pdfMDCG 2022-5 Borderline: https://ec.europa.eu/health/document/download/b5a27717-229f-4d7a-97b1-e1c7d819e579_en?filename=mdcg_2022-5_en_0.pdfWHO 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