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 PositionPaper-AI Designation-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–G008.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/