Process Description
The transition from Directive 93/42/EEC (MDD) to Regulation (EU) 2017/745 (MDR) required an update of the clinical evaluation for Class III vascular implants to comply with more stringent documentation requirements. A key element of this process was the development of a Clinical Evaluation Plan (CEP), defining the methodology for the collection and appraisal of clinical data.
In parallel, a systematic literature review was performed, integrating the State of the Art (SOTA) approach, which involved the evaluation of the most recent clinical research, professional guidelines, and medical standards. This enabled a reliable and up-to-date characterization of the clinical profile of the devices.
Conducting the clinical evaluation in accordance with MDR requires not only meticulous data preparation and analysis but also continuous post-market surveillance and transparent, comprehensive presentation of findings. This approach ensures regulatory compliance while also reinforcing patient and stakeholder confidence in the safety and quality of the medical devices offered.
Outcomes
- The Clinical Evaluation Plan (CEP) and Clinical Evaluation Report (CER) were developed in full compliance with MDR requirements.
- The literature analysis provided strong clinical evidence supporting the safety and performance of the implants, confirming alignment with current clinical standards.
- The clinical evaluation process enabled complete alignment of documentation with MDR, supporting the long-term post-market surveillance strategy for the medical device.
