Basics - Performance Evaluation of In-vitro-Diagnostics

What is a performance evaluation of IVDs?

The performance evaluation of in vitro diagnostics is similar to the clinical evaluation of medical devices. Of course, with various differences with regard to the specific requirements for IVDs.

It is therefore a matter of determining the applicable General Safety and Performance Requirements in relation to the performance characteristics under normal conditions of use of the device. In addition, an assessment must be made of the interference(s) and cross-reaction(s) and the acceptability of the risk-benefit ratio.

This is done in the performance evaluation based on data on scientific validity and analytical and clinical performance that provide sufficient clinical evidence.

Is a performance evaluation only necessary for the IVDR?

No. A performance evaluation (PE) for IVDs is also required under 98/79/EC (IVDD). However, the requirements are described in much more detail in the IVDR.

The new requirements are very similar to those for the clinical evaluation of medical devices. Therefore, we suspected very early on that such performance evaluations would require a similar scope and structure. This assumption has already been confirmed by experts from various notified bodies.

We started a long time ago to develop concepts for the preparation of performance evaluations according to IVDR, as this topic will bring radical changes for IVD manufacturers. On the one hand, the amount of work required for the preparation of performance evaluations is very high due to the increased requirements. On the other hand, the effort increases even more because many IVDs are classified higher and therefore more frequent updates of the PEs are necessary.

When must the performance evaluation be prepared?

Ideally, it should be started early during product development. After all, it is quite possible that risks that have not yet been considered in the PE will be identified. Such data must then be used to feed into risk management. In fact, however, the development process is often not started until after the product has been developed - the IVD is therefore already finished and the PE is created afterwards. For manufacturers who already know the risks of their products, this even works quite well.

In view of the fact that many IVDs are already on the market, but a completely new format of performance evaluation is expected, the situation described above is also true. The products are fully developed and even already on the market. The "new performance evaluation" is then created.

As with the clinical evaluation, the PE has to be updated regularly or as needed throughout the product life cycle. The exact requirements for this are related to the risk class of the IVD.

Which documents must be generated?

A plan and a report on the performance evaluation must be produced. It is not mandatory whether both documents should be single or combined in one. Both have advantages and disadvantages and are handled differently.

Is training really useful?

As a general rule, we advise everyone to attend a training course or workshop before starting to work independently and making a performance evaluation. Of course, you can start without training - it all depends on how much time you allow yourself and how many attempts you want to make. Creating a document is one thing. Having the document reviewed by a notified body or authority, for example in an audit, is quite another. Then it quickly becomes clear whether the requirements have been correctly interpreted and the procedure is really objectively and accurately documented.