Clinical evaluations encompass the collection, analysis and assessment of clinical data pertaining to a medical device to verify safety and performance, including clinical benefits. Clinical evaluations must be based on clinical data derived from scientific literature, clinical experience, clinical trials, or any combination of these.
Guidance for conducting clinical evaluations is provided in document MEDDEV 2.7/1 according to the requirements of the European Directive 93/42/EEC (MDD) as amended by directive 2007/47/EC. Both revision 4 of MEDDEV 2.7/1 and the MDR 2017/745 raise the requirements for clinical data compared to the previous status quo. Although full compliance with the MDR will not be mandatory until mid-2020, the examination of clinical evaluations by notified bodies has recently become considerably more stringent. As a consequence, manufacturers of medical devices need to invest substantial effort to compile clinical evaluations.
Our Service for your Clinical Evaluation
Medical Mind can support medical device manufacturers and suppliers by providing the following services:
- Compilation of clinical evaluation plans (CEP) and clinical evaluation reports (CER) in compliance with the regulatory requirements for medical devices and combination products
- Clinical literature reviews based on methodological searches and thorough data appraisal
- Safety data base analysis
- Identification and assessment of equivalent devices in accordance with MEDDEV 2.7/1, rev. 4, MDD and/or the MDR
- Post market clinical follow-up (PMCF) plan and PMCF evaluation report
- Clinical evaluations for deriving the objectives of forthcoming clinical investigations
- Creation and/or development of processes for future updates to your clinical evaluations
Please note: Successful CE-approval can be supported by an exclusively literature-based clinical evaluation. However, this approach depends on the device in question, potential equivalent devices, and the quality of available clinical data. We also offer comprehensive services for medical device clinical trials.