The miss rates of corona antigen self-tests as reported in practice are quite shocking compared those reported in the self-test labelling. What causes those misses? What do we know based on data from clinical practice? I looked at 6 reasons (and a bonus reason) that may explain why self-tests miss a diagnosis, and checked the […]
Lees meerWith the updated references of harmonised standards for medical devices, ISO 14155: 2020 is THE GCP standard for medical device clinical investigations, and since as of May 26th 2021 the MDR fully applies you may want to familiarize yourself and your team with the changes to ensure proper clinical data collection in line with this […]
Lees meerCCMO News item: Conditions for (re)starting clinical research in healthcare institutions and CRUs aligned —– NEN publishes new recommendations for reusing single-use medical devices and provides guidance for non-medical face masks (Dutch) NEN quality mark for masks for public use ready as per December 15, 2020 —- The European Data Protection Board (EDPD) adopted guidelines […]
Lees meerMHRA post-transition period information: Guidances for industry and organisations to follow from 1 January 2021. Last updated on December 11, 2020.
Lees meerA European Commission’s document with frequently asked questions on the Unique Device Identification (UDI) System under the EU medical devices Regulations 2017/745 and 2017/746.
Lees meerhttps://www.iso.org/standard/71690.html
Lees meerBrexit and clinical research The United Kingdom (UK) has left the European Union (EU) on 31 January 2020. A transitional period is now in place until 31 December 2020. During this period, all EU laws and regulations will continue to apply in the UK. Virtually nothing will change for the public and for businesses during […]
Lees meerOn 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 […]
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