Medical Device News - December 2021 Regulatory Update

This is the last Medical Device news episode of the year and I hope this will help you a lot.
We will talk about EU updates, UK and Switzerland, US FDA, and Saudi Arabia.
Check show notes: https://podcast.easymedicaldevice.com...

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► Links from the Video

• EUDAMED
○ Commission implementing regulation 2021/2078: https://eur-lex.europa.eu/legal-conte...
○ EUDAMED webpage: https://ec.europa.eu/health/md_eudame...
○ EUDAMED Playground: https://webgate.training.ec.europa.eu...
○ UDI/Devices guidance: https://ec.europa.eu/health/sites/def...
○ Infographic EUDAMED: https://ec.europa.eu/health/sites/def...
○ Categorization of devices: https://ec.europa.eu/health/sites/def...
○ Registration process: https://ec.europa.eu/health/sites/def...
• IVDR expert panel
○ View in the context of the Performance Evaluation Consultation Procedure (PECP): https://ec.europa.eu/health/sites/def...
○ Following MDCG 2021-22 https://ec.europa.eu/health/sites/def...
• EU Reference Laboratories (EURL)
○ Feedback on Draft implementing regulation open until December 17th, 2021: https://ec.europa.eu/info/law/better-...

• Germany: Contact Persons for Medical Devices https://www.bfarm.de/EN/Medical-devic...
• Ireland - HPRA: In-house Manufacturing of in vitro diagnostic medical devices - Survey
○ Due December 17th, 2021 http://www.hpra.ie/homepage/medical-d...
• Ireland - HPRA: Update on the creation of Free Sale Certificate in Ireland: http://www.hpra.ie/homepage/medical-d...
• Annex XVI products - Finland - FIMEA
○ https://www.fimea.fi/web/en/-/supervi...
• CHRISTMAS BREAK
○ MHRA Christmas period: Clinical Investigation: https://www.gov.uk/guidance/notify-mh...
○ Belgium - FAMHP - Christmas period https://www.famhp.be/en/news/deadline...

• Switzerland: Registration of Economic Operators: https://www.swissmedic.ch/swissmedic/...
○ CHRN Database: https://opendata.swiss/en/dataset/mep...
○ How to obtain the CHRN: https://www.swissmedic.ch/dam/swissme...
• Switzerland - Procurement: https://www.swissmedic.ch/swissmedic/...
• UK MHRA: Review launched into the health impact of potential bias in medical devices: https://www.gov.uk/government/news/re...
• WORLD
• USA: Final rule for Medical Device De Novo Classification Process
○ https://www.fda.gov/medical-devices/w...
○ Podcast Episode 43 - How to register a Medical Device with FDA? (510k, PMA, DeNovo) How to register a Medical Device with FDA? (510k, PMA, de Novo...)
• USA: Draft Guidance 510K Device Software function SaMD
○ Webinar Dec 16th, 2021 - Draft Guidance: Content of Premarket Submission for Device Software functions: https://www.fda.gov/medical-devices/w...
○ Draft guidance: https://www.fda.gov/media/153781/down...
• USA: Voluntary eSTAR Program: https://www.fda.gov/medical-devices/p...
○ Non-in vitro diagnostic eStar Version 1: https://www.fda.gov/media/154429/down...
○ In Vitro Diagnostic eStar Version 1: https://www.fda.gov/media/154430/down...
• Saudi Arabia: Borderline products https://www.sfda.gov.sa/sites/default...

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