What is a clinical evaluation?
The clinical evaluation is the responsibility of every manufacturer of a medical device, regardless of the declared class of the medical device. It is a continuous procedure, with reliable methodology, to collect, assess and analyse clinical data on the medical device, to verify whether the clinical evidence provided confirms the conformity of the medical device with the essential requirements for safety and efficacy in use in accordance with the instructions provided by the manufacturer. The clinical evaluation makes it possible to determine the level of acceptability of the benefit-risk balance under the conditions of use of the medical device.
On what basis the clinical evaluation is performed?
The clinical evaluation shall be based on clinical data:
- a critical analysis of the scientific literature currently available concerning the safety, performance, design characteristics and intended use of the product, where equivalence of the product with the product to which the data relates has been demonstrated.
- a critical evaluation of the results of all clinical trials,
- a critical overall assessment of the above mentioned data.
The clinical assessment report is one of the documents in the technical dossier.
MDR Regulator provides the service of preparing a clinical assessment meeting the restrictive requirements of Regulation 2017/745 (MDR).