Medical Device News: December 2023 Regulatory Update

Medboard

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EU

EPSCO Meeting November 30th. 2023  -  MDR IVDR device risk of disruption: https://data.consilium.europa.eu/doc/document/ST-15385-2023-REV-2/x/pdf

Survey on Medical Devices -   Study supporting the monitoring of the availability of Medical Devices on the EU Market.

Information: https://ec.europa.eu/eusurvey/runner/MFandAR

Questionary: https://ec.europa.eu/eusurvey/files/6a4fd4cd-dfce-4fe1-bcaf-9f44eb00e471/650fed06-30d2-40b1-9ff0-e96c79b4eb96

Falsification of Medical Devices - Survey result: https://act.edqm.eu/s/XcPw5MDtYe49gmj/download/CMED-Survey-Report-Final%20%281%29.pdf

MDCG 2022-11 Rev 1 Position Paper - Call to NB to streamline the certification process https://health.ec.europa.eu/system/files/2023-11/mdcg_2022-11_en.pdf

EU IVDR Technical Documentation training - TEAM-NB Survey result

Training IVDR technical documentation February 1st, 2024: https://www.team-nb.org/wp-content/uploads/2023/11/Leaflet-IVD-TD-Manufacturers-Training-20240201.pdf

Result on Survey of MDR training: https://www.team-nb.org/mdr-technical-documentation-training-for-manufacturers/

DEHP Substance forbidden in Medical Devices - Extension to July 1st, 2030 : https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202302482Notified Bodies Situation - 2 new comers:

UDEM Turkey 41st NB under MDR: https://webgate.ec.europa.eu/single-market-compliance-space/#/notified-bodies/notifications/1004365?organizationVersion=7Scarlett NB B.VC. 42nd NB under MDR: https://api.tech.ec.europa.eu/nando-prod/files?repo=nando&id;=2feeb6d10d338167081ad0cf7af6683fe760cded&group;=NOTIFICATION&download;=true

Switzerland

Vigilance Reporting submission information  - Update your QMS procedures: https://www.swissmedic.ch/swissmedic/de/home/medizinprodukte/uebersicht-medizinprodukte/archiv/hinweis-einreichung-vigilance-meldungen-mep.html

Training EU MDR

Training EU MDR 2017/745 - December 11th - Green Belt Certification Program for EU MDR : https://school.easymedicaldevice.com/course/gb27

Medtech Conf

Your Medtech Conferences -  Register all your Events, Training, Conferences: https://medtechconf.com/

USA

FDA withdrawal - not anymore member of the GHWP: https://www.fda.gov/media/174142/download

Discontinuation in the USA - Notifying FDA of a permanent discontinuation: https://www.fda.gov/media/155245/download

Webinar on Companion Diagnostics - Oncology Drug Products used with IVD tests: https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/webinar-oncology-drug-products-used-certain-in-vitro-diagnostic-tests-pilot-program-12122023Canada

Medical Device Establishment Licenses annual review - You should receive your Christmas Package: https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/medical-devices-compliance-bulletin/annual-licence-review-2024.html

Saudi Arabia

Webinar: Clinical Trials of Medical Device Requirements - Click on the link in December 12th, 2023: https://www.sfda.gov.sa/en/workshop/93098South Africa

Guideline on Q&A; for Licensing of Medical Device Establishment - Learn how to start this activity: https://www.sahpra.org.za/wp-content/uploads/2023/02/SAHPGL-MD-07_v3-Guideline-on-Questions-and-Answers-Licensing-of-Medical-Device-Establishments55.pdf

Brazil

Argentina & Brazil signed a Mutual Recognition Agreement - For certificates for Medical Devices: https://www.argentina.gob.ar/noticias/anmat-y-anvisa-firmaron-el-primer-acuerdo-de-reconocimiento-mutuo-en-certificados-para

SmartEye

eQMS for Medical Device companies - Get your Demo now: https://smart-eye.io

Podcast Nostalgia

How to CE certify a calculator, risk score software as Medical Device? Cesare Magri: https://podcast.easymedicaldevice.com/258-2/

How to find a predicate Device for your 510k submission? Beat Keller: https://podcast.easymedicaldevice.com/259-2/

What is the situation regarding Digitalization in the Medtech industry? MedXD https://podcast.easymedicaldevice.com/260-2/

Easy Medical Device support - [email protected]

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