How do you keep your legacy medical devices CE marked once the Medical Device Regulation (MDR) applies in May 2021? Can you continue to do what you did under MDD and are you then OK? A month ago, the Medical Device Coordination Group (MDCG) released a guide with the “how to’s” in MDCG 2020-6, a […]
Lees meerWHO guideline for comment Although developed for pharmaceuticals, the referenced elements certainly also apply for medical devices.
Lees meerRegulation (EU) 2017/745 of April 5, 2017 First Corrigendum of May 3, 2019 Second Corrigendum of December 27, 2019 EU’s MDR (and IVDR) implementing measures rolling plan Guidance clarifying significant changes under MDR Article 120 of March 16, 2020
Lees meerhttp://www.fdalawblog.net/2020/03/court-determines-that-decades-worth-of-missing-data-must-be-published-on-clinicaltrials-gov-but-enforcement-of-reporting-violations-hinges-on-fda-discretion/
Lees meerThe new EU Manufacturer Incident Report (MIR) template (updated on June 12, 2020) is mandatory for reporting of incidents under the MDD/AIMDD or IVDD, or for serious incidents under the MDR or IVDR as of January 1, 2020.
Lees meerhttps://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/860787/Guidance_for_mfrs_on_clinical_trials_January_2020.pdf With practical instructions on when a clinical investigation is required, and the note that “notification to the MHRA will not be required if the medical device to be used is CE marked for the purpose under investigation” https://www.gov.uk/guidance/notify-mhra-about-a-clinical-investigation-for-a-medical-device
Lees meerRegulation (EU) 2017/746 of April 5, 2017 1st Corrigendum (May 3, 2019) 2nd Corrigendum (December 27, 2019) EU’s IVDR (and MDR) implementing measures rolling plan
Lees meerThe Council for International Organizations of Medical Sciences issued the course with the main aim to learn to navigate these CIOMS guidelines. The course includes example case studies and a certificate at the end. The purpose is not to replace a GCP-certificate but to assist the reader in their understanding of how to apply these […]
Lees meerOn Clinical Investigation On Clinical Evaluation On Clinical Evidence On Adverse Event reporting
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