European Commission
The article highlights the key points related to the manufacturers’ obligations in case of product supply being interrupted or discontinued.
EU
The article describes in detail the regulatory approach to be applied in the context of the importation and distribution of medical devices in the EU, focusing on the obligations of the parties involved.
EU MDR/IVDR
The Medical Device Coordination Group (MDCG), an advisory body of the European Commission in the sphere of medical devices, has published a guidance document dedicated to the current classification rules. The document is intended to assist medical device manufacturers...
EU MDR/IVDR
The Health Products Regulatory Authority (HPRA), the Irish regulating authority in the sphere of medicines and medical devices, has published a draft guidance document dedicated to new applications for wholesale distribution authorizations (WDAs), as well as...
Saudi Arabia
The Saudi Food and Drug Authority (SFDA), the country’s regulating authority in the sphere of medical devices, has published a guidance document dedicated to the approach to be applied for bundling/grouping medical devices intended to be marketed and used in the...
