The Intended Purpose
The essence of every medical device lies in its intended purpose and intended use. The formulation and content of these specifications significantly influence the benefit-risk assessment, required clinical data, verification and validation processes, as well as marketing strategies. Our team of experts vigilantly examines all interfaces, combining regulatory knowledge with […]
General Safety and Performance Requirements
General Safety and Performance Requirements The European Union (EU) regulation of in vitro diagnostic medical devices (IVDs) is centered on granting market access to IVDs that offer clinical benefit while ensuring the safety of patients, users, and others involved in their use. To achieve this, the regulation sets requirements that […]
Post Market Surveillance
Post Market Surveillance Since May 26, 2022, the In Vitro Diagnostic Regulation (IVDR) requirements for Post Market Surveillance (PMS) have been applicable to all IVD devices. However, some manufacturers are not fully aware of the additional obligations imposed by the IVDR. While PMS is not new for IVD manufacturers, the […]
Usefull Links
Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices The European Union In Vitro Diagnostics Regulation Swiss Medtech Regulating medical devices in the UK EUDAMED EUDAMED User Guide – Actor Registration Module Notified Bodies EMDN Code search (European […]