Medical Device News: January 2023 Regulatory Update
- EU MDR extension
- 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 extension proposal 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/
- Implementing rolling plan
- Implementation Rolling Plan: Regulation (EU) 2017/745 and Regulation (EU) 2017/746 – Latest update: November 2022 https://health.ec.europa.eu/system/files/2022-12/md_rolling-plan_en.pdf
- Borderline manual
- Manual on borderline and classification under Regulations (EU) 2017/745 and 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
- Team NB
- AI act for Notified Bodies – Team-NB Position Paper – The designation of notified 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
- Notified Bodies appointed
- QMD Services GmbH (NB 2962), 8th Notified Body designated 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 designated 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
- Training to attend and Books to read
- 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/
- MDCG 2022-17
- MDCG position paper 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
- MDCG 2022-18
- MDCG Position Paper on the application of Article 97 MDR to legacy devices for which the MDD or AIMDD certificate expires before the issuance of an MDR certificate https://health.ec.europa.eu/latest-updates/mdcg-position-paper-application-art97-mdr-legacy-devices-which-mddaimdd-certificate-expires-issuance-2022-12-09_en
- MDCG 2022-19 and 20
- Performance study application/notification documents 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 modification of performance 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
- 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
- Switzerland Annex XVI products
- Frequently Asked Questions on medical devices – FAQ MD: Update of the section “Products without medical purpose” https://www.swissmedic.ch/swissmedic/en/home/medical-devices/regulation-of-medical-devices/faq.html
- US Product Codes
- Non-Invasive Body Contouring Technologies https://www.fda.gov/medical-devices/aesthetic-cosmetic-devices/non-invasive-body-contouring-technologies
- Augmented Reality and Virtual Reality in Medical Devices https://www.fda.gov/medical-devices/digital-health-center-excellence/augmented-reality-and-virtual-reality-medical-devices
- SFDA Classification
- Guidelines for classification of medical devices and supplies https://www.sfda.gov.sa/sites/default/files/2022-12/MDS%E2%80%93G008.pdf
- PODCAST nostalgia
- Team-PRRC panel discussion https://podcast.easymedicaldevice.com/210-2/
- Is EU MDR extended? https://podcast.easymedicaldevice.com/211-2/
- Grow your LinkedIn Profile: https://podcast.easymedicaldevice.com/212-2/
4 Replies to “Medical Device News: January 2023 Regulatory Update”
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Useful info. Keep up the good work
Thanks Selvarasu, appreciated
Nice summary of a lot of recent developments and important updates! Delighted to have connected with you as a great global RA resource.
Thanks Monir.
Hi Ross, thanks for your support. Really appreciate your comment