According to the 4th amendment of the Medical Device Act, any medical device manufacturer is required to prepare and update the clinical evaluation for a medical device. The 4th revision of the MedDev guideline 2.7/1 of June 2016 additionally increased the requirements on the clinical evaluation of medical devices.
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
- Unspecific intended use or very narrow intended use
We will identify a quick, suitable way to comply with the MedDev 2.7/1 revision 4 requirements. You can profit from our experience in many indications and product groups as well as our contact with various notified bodies. You can fall back on our comprehensive experience gained in the preparation of more than 250 clinical evaluations of various product groups. We offer the following services in this regard:
- Preparation and update in accordance with our SOP and templates
- Check of your templates for compliance with current regulations
- Consulting for successful preparation of a clinical evaluation (check our seminar offer)
- Adaptation of your clinical evaluation after feedback from the notified body
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 direct contact with the person in charge of the preparation of the clinical evaluation.
Furthermore, we offer a seminar, which thematises the topic "clinical evaluation of medical devices”, updated according to the new MedDev 2.7/1 guideline. In this one-day intensive seminar you will become familiarized with the essentials for the appropriate operation of a clinical evaluation and the scientific literature search. Problematic issues will be addressed and a practice workshop is integrated (Flyer). We also gladly offer the seminar as an inhouse seminar or on alternative dates.