Medical Device News - May 2022 Regulatory Update
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Episode 178
Published
In this episode, I will update you regarding all the changes in the Medical Device Quality and Regulatory Field. Below are all the topics we will discuss during this episode. Don’t miss the latest updates.
EU
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EUDAMED & Certificate: https://ec.europa.eu/health/medical-devices-eudamed/notified-bodies-and-certificates-module_en
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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
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EUDAMED Economic Operator User Guide: https://webgate.ec.europa.eu/eudamed-static/documents/assets/guides/user_guide_eo_en.pdf
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Delegated acts: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=COM:2022:182:FIN
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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
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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
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MDSAP Audit Approach: https://www.fda.gov/media/157861/download
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FDA: Refuse to accept Policy for 510k: https://www.fda.gov/media/83888/download
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FDA Medsun Newsletter: https://www.fda.gov/media/157448/download
MEA
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Ethiopia: Labelling requirements: http://www.fmhaca.gov.et/wp-content/uploads/2022/04/Guidelines-for-Medical-device-Labeling.pdf
ASIA
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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
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Medtech Forum: https://www.themedtechforum.eu/
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SFDA: Webinar Clinical Evaluation and PMCF: https://www.sfda.gov.sa/en/workshop/86686
GUIDANCES
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MDCG Subgroup development and deliverables – https://ec.europa.eu/health/system/files/2022-04/mdcg_ongoing_guidancedocs_en.pdf
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MDCG 2022-5 Borderline: https://ec.europa.eu/health/document/download/b5a27717-229f-4d7a-97b1-e1c7d819e579_en?filename=mdcg_2022-5_en_0.pdf
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WHO Guidance: PMS for MD and IVD. https://www.who.int/publications/i/item/9789240015319
NOTIFIED BODIES:
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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:
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Episode 175: How to prepare an audit with Front Room Back Room: https://podcast.easymedicaldevice.com/175/
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Episode 176: How your PMCF is evaluated by a Notified Body with Matthias Fink from TÜV SÜD: https://podcast.easymedicaldevice.com/176/
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Episode 177: Training process with Rod Beuzeval and Katie Cooney from Trinzo and Meddev Solutions: https://podcast.easymedicaldevice.com/177/
In this episode, I will update you regarding all the changes in the Medical Device Quality and Regulatory Field. Below are all the topics we will discuss during this episode. Don’t miss the latest updates.
EU
- 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/
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