In the conformity assessment routes you use when you introduce your medical devices to the market, you are required to “prove that your device provides the required performance and does not compromise patient health and safety, and eliminate any potential risks”.
“Clinical evaluation” process, which is an important tool for such proof, appears to be a study that you need to perform in the life-cycle of your product and update at intervals.
MDD (93/42 EEC amended by 2007/47/EC) that is now in force and MDR (EU 2017/745 Medical Device Regulation) that will enter into force in May 2020 and replace MDD widely includes clinical evaluation of medical devices. Published in 2016, MEDDEV 2.7.1 Rev.4 guidelines provide guidance to you and to notified bodies.
For the Clinical Evaluation Report, experts at DeSia
- Determine the General Safety and Performance requirements that need to be supported with clinical data.
- Identify the products that are similar to yours.
- Examine the clinical studies in the literature and choose the ones that are suitable for you.
- Analyse written sources and create evaluation reports for your medical device.
- Ensure that these reports are reflected in risk analyses and instructions for use.
- Submit the final version of the report to you to take your opinion and take note of your requests for change in order to finalize the report.
- Receive approval for your CER that requires approval by a medical doctor who is a specialist in the field of the device upon your request and share such approval with you.
- Accompany your staff for report presentation if your Certification Body requests a presentation of your CER.
With the Clinical Data Evaluation Document he prepares, DeSia not only facilitates the receipt of sales approval by manufacturers but also provides valuable information to companies on the clinical use, claims and risks of their products.