Importance of Clinical Evaluations
In the evolving landscape of medical device regulation, clinical evaluation has taken centre stage. With the introduction of the Medical Device Regulation (EU) 2017/745 (MDR), the requirements around clinical evaluations have been significantly reinforced compared to the old Medical Device Directive (MDD). Understanding and meeting these requirements is not just a legal necessity; it is ...
State-of-the-Art in Clinical Evaluation Reports
In accordance with the Medical Device Regulation, manufactures must show that devices are safe and perform as intended, taking into account the generally acknowledged ‘state of the art’. This term can also be found in the MEDDEV 2.7/1 rev 4 guidance, which guidance also demands that the manufacturer presents a thorough description of the state ...
Performance Evaluation
The Performance Evaluation is a crucial element of a device’s conformity with the general safety and performance requirements (GSPR) of Annex I of the EU IVD medical device Regulation 2017/746 (IVDR), which should take into account the device’s normal conditions of its intended use and evaluate of the interference and cross-reaction and of the acceptability ...
Clinical Evaluation
The Clinical Evaluation Report (CER) is a document that presents all the clinically relevant data collected for a particular device. The Clinical Evaluation is a crucial element of a device’s conformity with the general safety and performance requirements (GSPR) of Annex I of the EU Medical Device Regulation 2017/745 (MDR), which should take into account ...
