CCMO 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 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
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