Europe
The SwissMedic, the authority responsible for medical device regulations in Switzerland, has published, in coordination with the EU and MDR, updated regulations: new Medical Devices Ordinance (MedDO) and Clinical Trials for Medical Devices Ordinance (ClinO-MD). These...
COVID-19
The LÆGEMIDDELSTYRELSEN, the Danish Medicines Agency, published guidance describing the extraordinary measures for clinical trials in the context of the outbreak of the Coronavirus Disease 2019 (COVID-19). COVID-related Regulatory Background The Danish Medicines...
Europe
The Slovenian Agency for Medicinal Products and Medical Devices (JAZMP) issued guidance dedicated to the regulatory requirements of protective elements on colored drawings on medical device packages. In particular, the document describes specific aspects to be...
The European Commission (EC), the medical device regulating authority of the European Union, issued a new regulation regarding standardization aspects in the context of Medical Devices Regulation 2017/745 (MDR) and In Vitro Diagnostic Medical Devices Regulation...
The Medical Device Coordination Group (MDCG), an advisory body composed of representatives of all Member States who are focused on the improvement of the existing regulatory framework, recently issued guidance dedicated to medical devices containing ancillary...
Europe
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) issued guidance on 3D printing of medical devices and components in the context of the outbreak of the Coronavirus Disease 2019 (COVID-19). Scope of the MHRA Guidance The present guidance published by...
