First steps prior creating a clinical evaluation

Why are clinical evaluations so extensive?

In the past, it was often simply a physician who pulled up a few publications and, in conjunction with his expertise, assured that the product was safe and effective. This was the clinical evaluation report (CER). The idea that this is enough is still quite common. Even today, we still receive such documents and encounter great astonishment when we explain our approach. However, the requirements of 93/42/EEC and (EU)2017/745 require a thorough and objective procedure. This must be methodologically sound and well defined. If one now compares the "early CERs" with the applicable requirements, it quickly becomes clear that they do not meet the requirements by far. The procedure, as it is required, is so complex because every detail must be precisely documented. Proof of objectivity requires that all decisions made, for example, on the preparation of the literature search protocol and the exclusion of literature, are comprehensibly justified. This alone makes the part of the literature analysis enormously extensive. In addition, there are further aspects such as the interfaces to risk management, biocompatibility, usability and clinical experience data or data from post-marketing surveillance.

When should the creation of the clinical evaluation start?

Ideally, the process should start early during product development. After all, it is quite possible that risks or indications for a lack of usability are identified within the CER and that have not yet been considered. Such data must then be used to feed into risk management. On the other hand, it may also be necessary to adapt the design of the product. In fact, however, the development of the medical device is often already completed when the creation of the CER begins. For manufacturers who are already well aware of the risks of their products, this also works quite well.

Which documents must be generated?

A clinical evaluation plan and report must be drawn up. It is not mandatory whether both documents should be separate or combined into one. Both have advantages and disadvantages and are handled differently.

When must the clinical evaluation be updated?

This depends on the risk class of the medical device. For class III products and implantable products, updates must be made at least once a year - this is required by the MDR. For other risk classes, manufacturers must decide for themselves when a planned update is necessary. Post-marketing surveillance activities can also be a trigger in addition to the planned updates.

Is training really useful?

As a general rule, we advise everyone to attend a training course or workshop before starting to work independently and create a CER. Of course, you can start without training - it all depends on how much time you allow yourself and how many starts you want to make. Creating a document is one thing. Having the document checked 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. In our experience, independently created CERs without specific prior knowledge always lead to deviations and many discussions. We therefore make a clear recommendation to attend a training course or workshop beforehand.

One thing we must not forget: Clinical evaluation is an important element in demonstrating compliance with the general safety and performance requirements. These in turn are required for the approval of a medical device. Devices that can have a positive effect on people's health can, of course, also have a negative effect. The approval and the associated documents to be drawn up are the basis for ensuring that the benefits of medical devices outweigh the risks. So you should always take a device approval seriously!