MDR: Clinical evaluation without your own data? Almost impossible now!

As a manufacturer you have to guarantee the safety and performance of your device throughout the entire product lifecycle. Both, safety and performance, are established through clinical evaluation and assessed continuously through constant market observation.

The MDR now turns the requirements of clinical evaluation upside down: In cases where it used to be sufficient to establish clinical evaluation on the comparability with another device (principle of equivalence) or based on literature, own clinical data will have to be generated in most cases.

What are the actual clinical functions of your device? And when is it maybe sufficient to prove the efficacy with non-clinical data? Together we will know more quickly.
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@ Wie kann der Bedarf an klinischen Daten ermittelt werden?

How to determine the requirements for clinical data?


1) Identification of the clinical functions of the product

2) Assessment which of the clinical functions can be verified by preclinical studies

3) Investigation and appraisal of suitable literature concerning the clinical functions

4) Analysis of the requirements for Post Market Clinical Follow-Up (PMCF) activities

PMCF activities

If clinical data is required, the following concepts might also be considered:
  • Follow-up of patients from clinical investigation before market approval,
  • Observational studies (collecting data under routine conditions),
  • Analysis of retrospective data of users or patients who have already gained experiences with the device,
  • Analysis of other post-market surveillance activities (e.g. service reports, hotline calls, customer complaints, etc.).

PMCF becomes mandatory

The MDR requires PMCF activities, i.e. the systematic collection of clinical data after the market launch of the medial device, proving the safety and clinical performance of the device.

These PMCF activities are defined in a PMCF plan, which becomes an integral part of the technical documentation and is regulated by the QMS. The data collected by PMCF is used to update the clinical evaluation in regular intervals. The advantage: PMCF studies are clearly easier to organize and conduct than clinical investigations that are conducted before the CE marking is granted.

Our services in this field

To be prepared for and successful in the future not only the relevant expertise in terms of clinical evaluation and verification is necessary but also the knowledge and experience of the actual clinical functions of a device and when it might be sufficient to prove efficacy by means of non-clinical data; because in many cases in vitro experiments in a laboratory may be conducted instead of extensive clinical tests.


Our services
  • Developing a relevant strategy how to generate clinical data,
  • Supporting the development of PMCF processes and plans and
  • Helping with the successful implementation of PMCF activities.

We look forward to getting to know you!