February 01, 2022

Medical Device News - February 2022 Regulatory Update

30 minutes

The February 2022 Regulatory Update contains a lot of information that may help you to maintain your team up-to-date with the new requirements.

Agenda:

IVDR news on transition, Expert Panel and Finland reminder

Clinical Trial Regulation in EU and UK

Training EU MDR 2017/745

EUDAMED Certificate module

EU Reinforced role for EMA on medical device and medicinal product shortage

Harmonized Standards

Annex XVI Draft

Switzerland Good Reprocessing Practices

Re-registration within MHRA

Bahrain medical device that doesn’t need registration

Newsltetter: FDA Medsun and Japan PMDA

MDCG guideline

Notified Body situation

EMD Podcast

LINKS

IVDR

IVDR: (EU) 2022/112 : https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32022R0112&from=EN

Expert Panel: Performance Evaluation: https://ec.europa.eu/health/medical-devices-expert-panels/experts/list-views-provided-and-ongoing-consultations-under-pecp_en

Finland – FIMEA: At home-test Covid 19: https://www.fimea.fi/web/en/-/fimea-reminds-importers-and-distributors-of-covid-19-at-home-tests-of-the-special-requirements-related-to-the-tests

Clinical

Regulatory harmonization of clinical trials in the EU: Clinical Trials Regulation to enter into application and new Clinical Trials Information System to be launched https://www.ema.europa.eu/en/news/regulatory-harmonisation-clinical-trials-eu-clinical-trials-regulation-enter-application-new

UK: Consultation on proposals for legislative changes for clinical trials https://www.gov.uk/government/consultations/consultation-on-proposals-for-legislative-changes-for-clinical-trials

Training

Green Belt Certification Program Edition 16: February 21st to February 25th: https://school.easymedicaldevice.com/course/gb16/

Divers

EUDAMED Certificates module: https://ec.europa.eu/tools/eudamed/#/screen/certificates

Podcast episode 111 with Leon Doorn: https://podcast.easymedicaldevice.com/111/

EU – REINFORCED ROLE FOR THE EUROPEAN MEDICINES AGENCY IN CRISIS PREPAREDNESS AND MANAGEMENT FOR MEDICINAL PRODUCTS AND MEDICAL DEVICES https://data.consilium.europa.eu/doc/document/PE-76-2021-REV-1/en/pdf

Harmonized Standards (New Webpage): https://ec.europa.eu/health/medical-devices-topics-interest/harmonised-standards_en

European Commission: Draft Common Spec Annex XVI Consultation page: https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/11629-Products-with-an-aesthetic-or-non-medical-purpose-safety-requirements_en

Switzerland: Good Reprocessing Practices: https://www.swissmedic.ch/swissmedic/en/home/medical-devices/reprocessing—maintenance/reprocessing.html

UK Responsible Person: Re-registration of MHRA accounts: https://www.gov.uk/guidance/regulating-medical-devices-in-the-uk

Bahrain: Which Medical Device should not be registered: https://www.nhra.bh/Media/Announcement/MediaHandler/ImageHandler/documents/Announcements/Announcement2022_Circular%20No.%20(01)%202022_T0%20All%20Medical%20Devices%20Companies%20and%20Healthcare%20Facilities_Cases%20that%20Will%20Not%20be%20Included%20in%20Medical%20Devices%20Regulation_20220119.pdf

Newsletter

USA: Medsun Newsletter January 2022: https://www.fda.gov/media/155206/download

PMDA Japan: https://www.pmda.go.jp/files/000244668.pdf

Guidance:

MDCG 2022-1: Notice to 3rd country manufacturers of SARS-CoV-2 in vitro diagnostic medical devices https://ec.europa.eu/health/document/download/cd617093-f2bd-4a99-9058-9805ce4d0db3_en

MDCG 2022-2 General principle of Clinical Evidence for IVDs: https://ec.europa.eu/health/latest-updates/mdcg-2022-2-guidance-general-principles-clinical-evidence-vitro-diagnostic-medical-devices-ivds-2022-01-27_en

Notified Body

ITALCERT SRL EU MDR: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=notification.html&ntf_id=315596&version_no=10

PODCAST:

Episode 162: How to accelerate your laboratory test results? https://podcast.easymedicaldevice.com/162/

Episode 163: How to interview a QA RA Candidate? https://podcast.easymedicaldevice.com/163/

Episode 164: MDCG 2021-27: https://podcast.easymedicaldevice.com/164/

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