Clinical Affairs: About the clinical application of your IVD medical device

Clinical Affairs deals with all aspects of the performance evaluation of your IVD medical device. The aim of all activities is to demonstrate that the IVD medical device actually delivers the clinical benefit in practical application that was traded off against the risk in the risk management process. The clinical benefit of the device must be proven by data and observed and confirmed throughout the entire product life cycle.

Already in the initial phase of a device’s development, a systematic literature research in scientific databases should be conducted to prove the scientific validity: On the one hand this serves to ensure that known risks of similar products on the market may be excluded for your device; on the other hand it clearly reveals the present state of the art for your technology. These search results are then seamlessly integrated into your product development requirements. You are already familiar with possible comparable products as well as available clinical data. During the course of the further development process, a performance evaluation is prepared and filed as a central document for technical documentation; it is an obligatory prerequisite for CE marking.

Scientific Validity

Scientific validity refers to the demonstration of a connection between an analyte and a specific clinical or physiological condition. This connection is typically scientifically proven, but it is necessary to document it, as required by the IVDR, Annex XIII:

The manufacturer demonstrates scientific validity based on one of the following sources or combinations of these sources:
  • relevant information on the scientific validity of products measuring the same analyte or marker;
  • scientific literature (subjected to peer review);
  • consensual expert opinions/statements from relevant professional organizations;
  • results from studies demonstrating the mode of action;
  • results from clinical performance studies.

Register now: IVDR webinar in collaboration with BSI Group

How to Best Work with a Notified Body for an Efficient Transition

How to work with your Notified Body for an efficient transition to IVDR? On 20 March, we will provide you with actionable strategies and important insights:

Our guest speaker Charlotte Hess, Business Development Manager Regulatory Services for IVD at BSI, will present "The IVDR Application Process – What Do You Need to Know?".

Afterwards, Dr Sandra Reuter, Senior Expert IVD at Metecon, will share her experiences and tips on "IVDR Implementation – Lessons Learned & Best Practices" and show how you can make the most of the short IVDR transition period.

The webinar is free of charge, and is conducted in English.

More information on the webinar


The product is on the market, performance evaluation is all done?

No, because as the manufacturer you must ensure a safe and efficient product throughout the entire product life cycle. There are different possibilities to define suitable post-market performance follow-up (PMPF) activities in the scope of post-market surveillance (PMS) such as participating in ring trials, evaluating defined questions with a statistically significant number of patients, long-term observation of patients, or investigations about known risks in literature. Based on this data you identify possible problems of your product, eliminate them at an early stage and thus increasingly adapt your successor products to your users’ needs.

Get us involved in the planning of your PMS activities at an early stage and benefit from our know-how:

Together we identify the solution that suits you best, realize it promptly and in accordance with applicable regulations and are a competent partner for you and your notified body at any time.
Due to our long-term experience with a diverse variety of devices we quickly find the appropriate strategy for your performance evaluation. The result: a focused development process, an accelerated finalization of the submission file as influencing factors are disclosed early, and a safe and efficient IVD medical device.

Due to our long-term experience with a diverse variety of products, we quickly find the appropriate strategy for your clinical evaluation. The result: a focused development process, an accelerated finalization of the submission file as influencing factors are disclosed early, and a safe and efficient medical device for your company.

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