Medical Device news – May 2023 Regulatory Update

•Team-NB Sector Survey 2022 :https://www.team-nb.org/wp-content/uploads/members/M2023/Team-NB-MD-Sector-Survey-PressRelease-20230411.pdf

• MDCG planning available :https://health.ec.europa.eu/system/files/2023-04/md_events_2023_en_1.pdf •TEAM-NB position paper : https://www.team-nb.org/wp-content/uploads/members/M2023/Team-NB-PositionPaper-BPG-TechnicalDocEU-MDR-2017-745-V2-20230419.pdf

•Finland – Electronic Submission for Medical Devices :https://www.fimea.fi/web/en/-/electronic-submissions-for-medical-devices-will-be-opened-on-2-may-2023

•France- Digital Medical Application reimbursement :https://esante.gouv.fr/espace-presse/lancement-de-la-prise-en-charge-anticipee-des-dispositifs-medicaux-numeriques

• Switzerland – IVD performance studies : https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/mep_urr/bw600_00_016e_mb_performance_studies_with_ivd.pdf.download.pdf/BW600_00_016e_MB_Information_performance_studies_IVD_KlinVMEP.pdf

•Switzerland – IMDRF OFFICIAL OBSERVER :https://www.swissmedic.ch/swissmedic/en/home/news/mitteilungen/swissmedic-official-observer-imdrf.html

• UK – Transition from CE to UKCA :https://www.gov.uk/government/publications/implementation-of-the-future-regulation-of-medical-devices-and-extension-of-standstill-period/implementation-of-the-future-regulations

• Training EU MDR :https://school.easymedicaldevice.com/course/gb25 oTitle: USA: Draft guidance on PCCP for AI/ML :https://www.fda.gov/media/166704/download o USA: Radiation Sterilization Master File Pilot Program :https://www.fda.gov/medical-devices/medical-devices-news-and-events/cdrh-announces-radiation-sterilization-master-file-pilot-program.

o Australia: Regulation for software based medical devices :https://www.tga.gov.au/how-we-regulate/manufacturing/medical-devices/manufacturer-guidance-specific-types-medical-devices/regulation-software-based-medical-devices

o China: Guideline for Medical Device :https://www.cmde.org.cn/xwdt/zxyw/20230404163902154.html o India: List of Notified Bodies registered in India :

o Mexico, Colombia & Cuba sign the Acapulco Declaration : https://www.gob.mx/cofepris/articulos/se-firma-declaracion-de-acapulco-para-creacion-de-la-agencia-reguladora-de-medicamentos-y-dispositivos-medicos-de-latinoamerica-y-el-caribe?idiom=es oSaudi Arabia Webinars :

•May 9, 2023 Guidance on Medical Devices Classification https://www.sfda.gov.sa/en/workshop/88229 •May 22, 2023 Product Sterilization Requirements for Medical Devices https://www.sfda.gov.sa/en/workshop/88228

oPodcast Nostalgia

•Episode 227: What is a SOUP for your Software Development Christian Kaestner Medical Device HQ https://podcast.easymedicaldevice.com/227-2/

•Episode 228: Prepare your Audit like a PRO with Karandeep Badwal https://podcast.easymedicaldevice.com/228-2/

•Episode 229: Transition to Agile for Software as Medical Device: https://podcast.easymedicaldevice.com/229-2/

Ask Easy Medical Device . We can help you

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Who is Monir El Azzouzi?

Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs.

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