Europe
The article provides an overview of the implementing decisions issued by the European Commission for harmonized standards allowed to be applied in the context of general and in vitro diagnostic medical devices under the new regulatory framework. Table of...
EU MDR/IVDR
The Medical Device Coordination Group (MDCG), an advisory body of the European Commission, the EU regulating authority in the sphere of medical devices, has published updated guidance on standardization. Due to its legal nature, the document should neither be treated...
EU MDR/IVDR
The institution responsible for medical device regulations in Spain is Agencia Española de Medicamentos y Productos Sanitarios (AEMPS), a state agency within the Spanish Ministry of Health, Social Services and Equality. Spain, just like all the other members of the...
EU MDR/IVDR
The European Union has established the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) as replacements to the Medical Devices Directive (MDD) and ln Vitro Diagnostic Devices Directive (IVDD), which had previously been in place for almost 25...
