http://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
Lees meerISO 20916:2019
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