Medical Device News – October 2021 Regulatory Update

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/