Medical Device News: June 2022 Regulatory Update

Here is the news of the month. Enjoy.

NEWS

• Swiss: MRA situation for IVDR; https://ec.europa.eu/health/document/download/8dd260fd-0b67-415b-bf1e-36bdf8681674_en?filename=md_eu-switzerland_mra_in-vitro-diagnostic.pdf
• Swiss: new IvDV (Ordinance on in-vitro diagnostics): https://www.bag.admin.ch/bag/en/home/medizin-und-forschung/heilmittel/aktuelle-rechtsetzungsprojekte/revision-med-prod-verord-mepv.html
  • Swiss Odiv: https://www.fedlex.admin.ch/eli/cc/2022/291/fr
• Swiss: Performance studies of IVD: https://www.swissmedic.ch/swissmedic/en/home/medical-devices/klinische-versuche/leistungsstudien.html
  • 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
• EU: Team NB Survey: https://www.team-nb.org/wp-content/uploads/2022/05/Survey-2021-20220516.pdf
• EU: Harmonized standard for IVDR: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32022D0729
• EU: Harmonized standard for MDR: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32022D0757
• Italy: Establishment of the National Surveillance Network: https://www.salute.gov.it/portale/news/p3_2_1_1_1.jsp?lingua=italiano&menu=notizie&p=dalministero&id=5894
• Preparing for UKCA marking of Medical Device with Ronald Boumans: https://boumansconsulting.com/expert-center/tip-of-the-week/preparing-for-ukca-marking-of-medical-devices/
• Green Belt Certification June 2022: https://school.easymedicaldevice.com/course/gb19/

NOTIFIED BODY

• 3EC International –  IVDR 2017/746 – https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=notification.html&ntf_id=317359&version_no=3
• TÜV Nord – EU MDR 2017/745: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=notification.html&ntf_id=317538&version_no=8
• Berlin Cert – EU MDR https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.nb&body_type=NB&refe_cd=EPOS_43955
• Overview NB each stage: https://ec.europa.eu/health/system/files/2022-05/notifiedbodies_overview_en.pdf

GUIDANCE

• MDCG 2022-6 Guidance on significant changes regarding the transitional provision under Article 110(3) of the IVDR: https://ec.europa.eu/health/document/download/14c2d8dd-8489-4db5-b035-1c174f17fb54_en?filename=mdcg_2022-6.pdf
• MDCG 2022-7 Q&A UDI System: https://ec.europa.eu/health/document/download/b5429d14-25a9-4cfc-b059-355388f03e05_en?filename=mdcg_2022-7_en.pdf
• MDCG 2022-8 IVD Legacy devices: https://ec.europa.eu/health/document/download/76f9983e-164c-45f1-b2b9-c9e5050cefe9_en?filename=mdcg_2022-8_en.pdf
• MDCG 2022-9 Summary of safety and performance template: https://ec.europa.eu/health/document/download/b7cf356f-733f-4dce-9800-0933ff73622a_en?filename=mdcg_2022-9_en.pdf
• MDCG 2022-10 Q&A interface 536/2014 on clinical trials for medicinal products for human use and IVDR: https://ec.europa.eu/health/document/download/59abcc81-fd32-4546-a340-24c8fad4e2ac_en?filename=mdcg_2022-10_en.pdf

PODCAST

• Episode 179 – How to certify your Software as a Medical Device? With Vivek Thakkar: https://podcast.easymedicaldevice.com/179/
• Episode 180 – What happens after the IVDR Date of Application with Colm O’Rourke: https://podcast.easymedicaldevice.com/180/
• Episode 181 – What to learn about the EU Medical Device Situation? https://podcast.easymedicaldevice.com/181/
• Episode 182– Let’s introduce our eQMS Smarteye with Anindya Mookerjea: https://podcast.easymedicaldevice.com/182/

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