Medical Device News: December 2023 Regulatory Update

Medboard

• Medboard platform  Sponsor of the podcast https://www.medboard.com/

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_202302482
• Notified 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=7
  • Scarlett 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-12122023

Canada

• 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/93098

South 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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