EU MDR/IVDR
The Council of the European Commission concluded in a meeting on December 9th to address member states’ concerns over the challenges and issues in meeting current EU Medical Device Regulation (MDR) deadlines. Table of Contents Regulatory Background According to...
EU MDR/IVDR
The article provides an overview of the FAQ document addressing the key points related to notifications for medical devices. Table of Contents SwissMedic, a country’s regulating authority in the sphere of healthcare products, has published a guidance...
EU MDR/IVDR
The new article highlights the aspects related to non-conformity which does not impose unacceptable risks to health and safety. Table of Contents The Medical Device Coordination Group (MDCG), an advisory body of the European Commission (EC) responsible for medical...
EU MDR/IVDR
The article provides an overview of the guidance document explaining how Article 97 MDR should be applied to legacy devices. Table of Contents The Medical Device Coordination Group (MDCG), an advisory body of the European Commission in the sphere of medical devices,...
EU MDR/IVDR
The new article highlights the key points related to a change of authorized representative, as well as the ones related to responsible persons and marketing surveillance. Table of Contents The Medical Device Coordination Group (MDCG), an advisory body of the European...
EU MDR/IVDR
The new article describes in detail the aspects related to the responsibilities of authorized representatives as set forth under the existing framework, as well as the liability they could be subject to, and situations when they are allowed to initiate termination of...
