Medical Device News – October 2021 Regulatory Update

Medical Device made Easy Podcast

Here are all the topics that we will cover during this regulatory update. Don’t forget to contact easy medical device if you need an EU-authorised representative, a Swiss representative or a UK-responsible person.

HOT TOPIC

• Implementing Rolling Plan: https://ec.europa.eu/health/sites/default/files/md_sector/docs/md_rolling-plan_en.pdf
• EUROPA IVDR expert panel: https://ec.europa.eu/health/md_expertpanels/overview_en
• EUDAMED Device module https://ec.europa.eu/tools/eudamed/#/screen/home
• Helsinki Procedure 2021: https://ec.europa.eu/health/sites/default/files/md_sector/docs/md_border-class_helsinki-proc-mdr-ivdr_en.pdf
• Medtech Europe – Availability of IVD devices in May 2022 https://www.medtecheurope.org/resource-library/medtech-europe-survey-report-analysing-the-availability-of-in-vitro-diagnostic-medical-devices-ivds-in-may-2022-when-the-new-eu-ivd-regulation-applies/
• IMDRF Artificial intelligence: http://www.imdrf.org/docs/imdrf/final/consultations/imdrf-cons-aimd-mlmd-ktd-wgpd-n67.pdf

EMD training

• Green Belt Edition 14: https://school.easymedicaldevice.com/course/gb14/

SWISSMEDIC

• Swissmedic Information session September 2nd, 2021 https://www.swissmedic.ch/swissmedic/en/home/services/veranstaltungen/info-medizinprodukte-regulierung.html
• Swissmedic- Combination products: https://www.swissmedic.ch/swissmedic/en/home/news/mitteilungen/ch-bevollmaechtigter-kombiprodukte.html

MHRA

• MHRA- Transforming the regulation of Software and artificial intelligence as Medical Devices https://www.gov.uk/government/news/transforming-the-regulation-of-software-and-artificial-intelligence-as-a-medical-device
• Software and AI as Medical Device Change Programme https://www.gov.uk/government/publications/software-and-ai-as-a-medical-device-change-programme/software-and-ai-as-a-medical-device-change-programme
• MHRA Consultation on the future Regulation of Medical Devices in the UK. https://www.gov.uk/government/consultations/consultation-on-the-future-regulation-of-medical-devices-in-the-united-kingdom?utm_medium=email&utm_campaign=govuk-notifications&utm_source=5b7f9b8d-f894-4288-bc55-148816deedd2&utm_content=daily
• MHRA webinar – Consulting on Future of Medical Device Regulation for industry: https://www.eventbrite.co.uk/e/mhra-consultation-on-future-medical-devices-regulation-in-the-uk-industry-tickets-166144503683
• MHRA registration renewal: https://www.gov.uk/guidance/register-medical-devices-to-place-on-the-market#review-registration

SPAIN

• AEMPS – Carlos III Health Institute presents the National Registry of Circulatory and Respiratory Assistance Devices in Spain. https://www.aemps.gob.es/la-aemps/eventos/2021-eventos/presentacion-del-registro-renacer/
• Change of labeling and IFU for Swiss Manufacturers https://www.aemps.gob.es/informa/notasinformativas/productossanitarios/2021-productossanitarios/informacion-sobre-productos-sanitarios-en-base-al-acuerdo-de-reconocimiento-mutuo-mra-ue-suiza/

FDA

• USA Device Registration and Listing: https://www.fda.gov/medical-devices/how-study-and-market-your-device/device-registration-and-listing
• List of who must register and pay: https://www.fda.gov/medical-devices/device-registration-and-listing/who-must-register-list-and-pay-fee
• FDA – List of AI and Machine Learning ML devices: https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-and-machine-learning-aiml-enabled-medical-devices

NOTIFIED Body

• TÜV Rheinland Italia SRL: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=notification.html&ntf_id=314154&version_no=8

GUIDANCES

• Borderlines with Medical Devices https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1022543/Rev_Borderlines_with_medical_devices_and_other_products-_V1_4_80_.pdf
• FDA Electronic submission template for Medical Device 510k: https://www.fda.gov/media/152429/download

EMD Nostalgia

• Podcast Episode 144 https://podcast.easymedicaldevice.com/144/
• Podcast Episode 145 https://podcast.easymedicaldevice.com/145/
• Podcast Episode 146 https://podcast.easymedicaldevice.com/146/
• Podcast Episode 147 https://podcast.easymedicaldevice.com/147/

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