On Clinical Investigation and Evaluation: MDCG 2020-13 on clinical evaluation assessment report. CEAR is a report used by the notified body to document the conclusions of its assessment of the clinical evidence presented by the manufacturer in the clinical evaluation report (CER) and the related clinical evaluation that was conducted (July 2020). MDCG 2020-5 on […]
Lees meerThe International Coalition of Medicines Regulatory Authorities (ICMRA) has pledged its collective support in countering the global COVID-19 pandemic: ICMRA members have an important role to play in supporting the worldwide effort to fight COVID-19 pandemic. The members have stepped up their global collaboration to facilitate and expedite the development and evaluation of diagnostics and […]
Lees meerTo date numerous guidances, blogposts, webinars have been published addressing what one must and cannot do in the process of clinical evidence collection due to the COVID-19 pandemic (for overviews see here and here), and with this post I have no intention repeating that, but rather want to focus on the things we CAN do […]
Lees meerHow 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
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