https://www.internationalwomensday.com/
Lees meerhttps://eenvandaag.avrotros.nl/item/chinese-fabrieken-leveren-onze-ziekenhuizen-geen-medische-hulpmiddelen-meer-door-coronavirus-we-ve/
Lees meerhttps://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=34
Lees meerhttps://www.iso.org/standard/71690.html
Lees meerhttps://www.medtecheurope.org/news-and-events/press/medtech-europe-welcomes-the-ratification-of-the-brexit-withdrawal-agreement-by-the-united-kingdom-and-the-european-union/
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”
Lees meerGreat to the point piece by the chair of the Dutch Data Protection Authorities (sorry in Dutch only): https://autoriteitpersoonsgegevens.nl/nl/nieuws/blog-aleid-wolfsen-niet-meer-dan-nodig
Lees meerhttps://www.sciencemag.org/news/2020/01/fda-and-nih-let-clinical-trial-sponsors-keep-results-secret-and-break-law
Lees meerhttps://eenvandaag.avrotros.nl/item/regelwoede-pakt-funest-uit-voor-medisch-onderzoek-en-is-ook-slecht-voor-de-patient/
Lees meerhttps://medicaldevicesclinical.wordpress.com/2019/12/30/eu-mdr-deadline-may-2020-clinical-evidence-state-of-affairs-at-years-end/ With less than 5 months to go until application, the development of guidance on the clinical evidence collection process under the EU MDR is progressing scarily slow. The updated overview from December suggests we theoretically will get some more clinical guidance the next few days, but I would not bet on it. The 2-year delay in […]
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