According to the 4th amendment of the Medical Device Act, every medical device manufacturer has to prepare and update the clinical evaluation for any of their medical devices. The 4th revision of the MEDDEV guideline 2.7/1 (June 2016), which lists specifications for the preparation of clinical evaluations in detail, additionally increased the requirements on the clinical evaluation of medical devices. Furthermore, the EU regulation 2017/745 (MDR) stipulates the requirement of planning and executing a clinical evaluation for all medical products across Europe, regardless of risk classification. This also encompasses a post market clinical follow-up (PMCF).
The following problems frequently arise in this situation:
- Comprehensive requirements are not known or no templates exist in this regard
- No adequate personnel available or limited resources
- No clinical data or scientific publications can be found
- No equivalent devices known or only limited information of equivalent devices is available
- Problems with the identification/evaluation of the state of the art data
- Unspecific intended use or very narrow intended use
- Integration of PMS/PMCF-results into the clinical evaluation
We will identify a quick and suitable way to comply with the MEDDEV 2.7/1 revision 4 and MDR requirements. You can benefit from our experience in many indications and product groups as well as our contact with various notified bodies. We offer the following services in this regard:
- Preparation and update in accordance with your or our SOP and templates
- Review of your templates for compliance with current regulations
- Consulting for successful preparation of a clinical evaluation
- Identification and documentation of the current state of the art
- Adaptation of your clinical evaluation after feedback from the notified body
- Assisting in the preparation of a plan for the clinical evaluation (CEP)
- Assisting in the preparation of a PMCF-plan
We will stay in close contact with you and inform you continuously about the progress of the project and possible problems, to ensure a timely finalization. You will be in personal contact with the author of the clinical evaluation.
Furthermore, we offer a seminar, which comprises the topic "clinical evaluation of medical devices”, updated according to the MEDDEV 2.7/1 and MDR guidelines. In this one-day intensive seminar you will learn the essentials for the appropriate preparation of a clinical evaluation and the scientific literature search. Problematic issues will be addressed and a practice workshop is integrated (Flyer).