News

26.04.18

Clinical Evaluation Plan

Since the MEDDEV 2.7/1 revision 4, dated June 2016 it has been necessary to analyze the scope of the clinical evaluation in advance of the evaluation itself and with reference to the specific case. Furthermore, the scope must be stated in a clinical evaluation plan (CEP) (stage 0, scoping). The new Medical Device Regulation (MDR, EU 2017/745) requires a CEP as separate document.

novineon CRO has already developed such a plan. It complies with the requirements of the MDR and MEDDEV 2.7/1 and uses the CEP to fulfill the future regulatory requirements of the MDR.

All open questions regarding the device to be evaluated are clarified in advance with the manufacturer and documented in the CEP.

In particular, the design of our CEP makes it possible to clarify the following critical points before the clinical evaluation:

  •   Availabilty of comparitive products
  •   Demonstration / discussion of equivalence with one comparative product
  •   Availability of clinical data
  •   Strategy of clinical evaluation

This CEP is of particular interest for medical devices, for which the regulatory classification with respect to equivalency and clinical data is yet to be clarified. This applies in particular to new and further developments and medical devices with innovative design features or materials.

The CEP determines the feasibility of clinical evaluation by means of literature research and provides a road map for the clinical evaluation itself. In the event that a clinical evaluation can be done by means of literature research, parts of the CEP shall be included in the final clinical evaluation for reasons of cost-efficiency.

The new MDR became effective on May 25, 2017 and the transition period ends in May 2020. A separate CEP is required after this time.

For further information please contact us: info novineon.com.