00:00 Intro
01:35 EU MDR expansion
○ Implementation of the Medical Device Regulation https://data.consilium.europa.eu/doc/document/ST-15520-2022-INIT/en/pdf
○ Provisional Agenda 9th Meeting – Implementation of the Medical Device Regulation (MDR) https://data.consilium.europa.eu/doc/document/ST-15453-2022-INIT/en/pdf
○ Implementation of the Medical Device Regulation (MDR): EU MDR Transition Period expansion proposition by the European Commission. https://video.consilium.europa.eu/event/en/26353
○ Erik Vollebregt Article: https://medicaldeviceslegal.com/2023/01/01/mdr-and-ivdr-outlook-for-2023/
04:29 executing rolling strategy
– Implementation Rolling Plan: Regulation (EU) 2017/745 as well as Regulation (EU) 2017/746 – Latest upgrade: November 2022 https://health.ec.europa.eu/system/files/2022-12/md_rolling-plan_en.pdf
06:25 Borderline handbook
– Manual on borderline as well as category under Regulations (EU) 2017/745 and also 2017/746 – Version2 – December 2022 https://health.ec.europa.eu/latest-updates/manual-borderline-and-classification-under-regulations-eu-2017745-and-2017746-version2-december-2022-2022-12-15_en
08:30 Team NB – AI represent Notified Bodies
– Team-NB Position Paper – The classification of alerted bodies under the upcoming Artificial Intelligence Act https://www.team-nb.org/wp-content/uploads/members/M2022/Team-NB%20PositionPaper-AI%20Designation-V1-20221216.pdf
10:20 Notified Bodies selected
– QMD Services GmbH (NB 2962), 8th Notified Body marked under IVDR (EU) 2017/746 https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=notification.html&ntf_id=320456&version_no=1
– ICIM S.P.A., 36th Notified Body marked under MDR (EU) 2017/745 https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=notification.html&ntf_id=320256&version_no=12
11:31 UK Approved bodies
– UK Approved bodies. https://www.gov.uk/government/publications/medical-devices-uk-approved-bodies/uk-approved-bodies-for-medical-devices
12:35 Training to participate in as well as Books to review
– Green Belt 24th Edition: https://school.easymedicaldevice.com/course/gb24/
– EUDAMED Simplified 28th February 2023: https://eudamed.com/index.php/eudamed-training/
– PRRC Training 28 Feb 2023: https://boumansconsulting.com/prrc-academy-cat/2023-02-28-03-07-in-house-manufacturer-prrc-starter-training/
– Erik Vollebregt Book – easymedicaldevice10 https://medicaldeviceslegal.com/2022/10/27/the-2nd-edition-of-the-enriched-mdr-and-ivdr-is-available-now/
14:27 MDCG 2022-17
– MDCG statement of principles on ‘hybrid audits’ – December 2022 https://health.ec.europa.eu/latest-updates/mdcg-2022-17-mdcg-position-paper-hybrid-audits-december-2022-2022-12-06_en
15:27 MDCG 2022-18
– MDCG Position Paper on the application of Article 97 MDR to heritage tools for which the MDD or AIMDD certification runs out prior to the issuance of an MDR certification https://health.ec.europa.eu/latest-updates/mdcg-position-paper-application-art97-mdr-legacy-devices-which-mddaimdd-certificate-expires-issuance-2022-12-09_en
17:42 MDCG 2022-19 and also 20
– Performance research study application/notification papers under Regulation (EU) 2017/746 https://health.ec.europa.eu/latest-updates/mdcg-2022-19-performance-study-applicationnotification-documents-under-regulation-eu-2017746-2022-12-12_en
– Substantial alteration of efficiency research study under Regulation (EU) 2017/746 https://health.ec.europa.eu/latest-updates/mdcg-2022-20-substantial-modification-performance-study-under-regulation-eu-2017746-december-2022-2022-12-14_en
18:26 MDCG 2022-21
– Guidance on Periodic Safety Update Report (PSUR) according to Regulation (EU) 2017/745 https://health.ec.europa.eu/latest-updates/mdcg-2022-21-guidance-periodic-safety-update-report-psur-according-regulation-eu-2017745-december-2022-12-16_en
20:13 Switzerland Annex XVI items
– Frequently Asked Questions on clinical gadgets – FAQ MD: Update of the area “Products without clinical function” https://www.swissmedic.ch/swissmedic/en/home/medical-devices/regulation-of-medical-devices/faq.html
21:52 United States Product Codes
○ Non-Invasive Body Contouring Technologies https://www.fda.gov/medical-devices/aesthetic-cosmetic-devices/non-invasive-body-contouring-technologies
○ Augmented Reality as well as Virtual Reality in Medical Devices https://www.fda.gov/medical-devices/digital-health-center-excellence/augmented-reality-and-virtual-reality-medical-devices
23:31 SFDA Classification
– Guidelines for category of clinical gadgets and also products https://www.sfda.gov.sa/sites/default/files/2022-12/MDS%E2%80%93G008.pdf
25:02 PODCAST fond memories
– Is EU MDR prolonged? https://podcast.easymedicaldevice.com/211-2/
– Team-PRRC panel conversation https://podcast.easymedicaldevice.com/210-2/
– Grow your LinkedIn Profile: https://podcast.easymedicaldevice.com/212-2/
27:52 Easy Medical Device assistance
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#easymedicaldevice #medicaldevice #regulatorycompliance
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