Medical Device News – June 2021 Update [EU MDR Date of Application]

Ok, this month the EU MDR is LIVE so we will talk about that. The date of application for EU MDR 2017/745 was May 26th, 2021 and there is a lot of information that I will share with you.

We will talk about

• EU MDD bye bye party
• Webinars
• EU MDR impact on other countries
• Swixit
• Turkxit
• IVDR 2017/746
• Notified Body Situation
• MDCG guidance
• IMDRF guidance
• Podcast
• Live session
• Erik Vollebregt book

Links from the Video

HOT TOPICS

• Portugal Inframed: https://www.infarmed.pt/web/infarmed/noticias/-/journal_content/56/15786/4404079
• Italy: https://www.salute.gov.it/portale/news/p3_2_1_1_1.jsp?lingua=italiano&menu=notizie&p=dalministero&id=5499
• Spain AEMPS: https://www.aemps.gob.es/informa/notasinformativas/productossanitarios/2021-productossanitarios/hoy-comienza-a-aplicarse-en-la-union-europea-el-nuevo-reglamento-de-productos-sanitarios/
• Belgium AFMPS: https://www.afmps.be/fr/news/dispositifs_medicaux_reglement_2017745_applicable_des_aujourdhui
• France Webinar ANSM: 2h French Webinar explanation EU MDR: https://ansm.sante.fr/evenements/reunion-dinformation-sur-le-nouveau-reglement-europeen-relatif-aux-dispositifs-medicaux-1
• DG Health 2h Webinar for Patients – Safe and performant Medical Devices for all Webinar for Patients – Safe and performant Medical Devices for all
• UDI Helpdesk: https://eu-udi.zendesk.com/hc/en-150
• EMDN Nomenclature: https://webgate.ec.europa.eu/dyna2/emdn/
• Ireland: HPRA new EU Device Legislation Information Pack http://www.hpra.ie/docs/default-source/default-document-library/hpra-eu-device-legislation-info-pack.pdf?sfvrsn=0
• Australia: Consultation to change MD classification following EU MDR publication: https://www.tga.gov.au/medical-devices-reforms-reclassification-certain-medical-devices
• JAMS Report: https://www.camd-europe.eu/wp-content/uploads/2021/05/JAMS-Layman-version-final-report-2020.pdf

SWIXIT

• Revision of the Medical Device Legislation: https://www.bag.admin.ch/bag/en/home/medizin-und-forschung/heilmittel/aktuelle-rechtsetzungsprojekte/revision-med-prod-verord-mepv.html
• New Regulation applicable to MD as of May 26th, 2021: https://www.swissmedic.ch/swissmedic/en/home/news/mitteilungen/neue-regulierug-mep-26-05-2021.html
• New MedOD: https://www.fedlex.admin.ch/eli/cc/2020/552/en
• Swiss SRN for Swiss Manufacturers, Authorised Representatives and Importer upon demand. https://www.swissmedic.ch/swissmedic/en/home/medical-devices/market-access/registriernummer-chrn.html
• Notification of Medical Devices: https://www.swissmedic.ch/swissmedic/en/home/medical-devices/market-access/meldung-medizinprodukten.html

TURKXIT

• Team NB Letter to MDCG: https://www.team-nb.org/wp-content/uploads/2021/05/MDCG-Update_EU-Turkey-Customs-Union-Medical-Devices.pdf

IVDR 2017/746

• IVDR: TEAM NB – CA for class D devices https://www.team-nb.org/wp-content/uploads/2021/05/Team-NB-PositionPaper-ClassD-20210519-V4.4.pdf

Standard and Guidance

• MDCG 2021-09 – MDCG Position Paper on the Implementation of UDI requirements for contact lenses, spectacle frames, spectacle lenses & ready readers
• MDCG 2020-18: https://ec.europa.eu/health/sites/default/files/md_sector/docs/md_mdcg_2020_18_en.pdf
• MDCG 2021-08 Clinical investigation application/notification documents https://ec.europa.eu/health/sites/default/files/md_sector/docs/mdcg_2021-8_en.pdf
• MDCG 2021-7 Notice to manufacturers and authorised representatives on the impact of genetic variants on SARS-COV-2 in vitro diagnostic medical devices https://ec.europa.eu/health/sites/default/files/md_sector/docs/mdcg_2021-7_en.pdf
• IMDRF – PMCF Studies: http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-210325-wng65.pdf

EASY MEDICAL DEVICE

• FDA: Is the Emergency Use Authorization worth it? Michelle Lott https://podcast.easymedicaldevice.com/127/
• MDR is coming – Brace yourself Erik Vollebregt https://podcast.easymedicaldevice.com/128/
• EU MDR Survey: What is the industry opinion? Catherine Higginson https://podcast.easymedicaldevice.com/129/
• LinkedIn Live – All about PMCF with Cesare Magri https://www.youtube.com/watch?v=kq_c_hFhKeE
• Erik Vollebregt Book -The Enriched MDR and IVDR: https://medicaldeviceslegal.com/2021/05/24/the-enriched-mdr-and-ivdr-finally-available/