Mar 19, 2021
Australia and Oceania
The Therapeutic Goods Administration (TGA), an Australian regulating authority in the sphere of medical devices, has published detailed guidance dedicated to the regulatory requirements related to the cybersecurity aspects associated with medical devices. The document...
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Mar 19, 2021
EU MDR/IVDR
The European Commission (EC), the EU body responsible for medical device regulations, has published a Q&A document dedicated to in vitro diagnostic medical device conformity assessment and performance in the context of COVID-19. The guidance is intended to provide...
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Mar 19, 2021
Australia and Oceania
The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of medical devices, has published a consultation paper dedicated to the suggested regulatory approach with regard to the nanomaterials used in medical devices. The document...
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Mar 19, 2021
MDCG
The Medical Device Coordination Group (MDCG), an advisory body of the European Commission comprised of the representatives of all Member States, has published a guidance document dedicated to harmonized administrative practices and alternative technical solutions...
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Mar 19, 2021
EU MDR/IVDR
The United Kingdom has adopted a final version of a regulatory framework for medical devices to be in force after Brexit. The new legislation prescribes the approaches to be applied with regard to the regulatory procedures associated with placing medical devices on...
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