Mandatory Clinical Investigation and Contract between Competitors

Manufacturers shall conduct a clinical evaluation in accordance with Article 61 of the MDR, in order to demonstrate compliance with the relevant general safety and performance requirements.

According to point 3 of that article, the clinical evaluation may be based on:

• A critical analysis of the scientific literature for equivalence with medical devices already on the market; or
• A critical analysis of the results of clinical investigations carried out, including any alternative treatment options available for the same purpose.

The above choice is generally at the discretion of the manufacturer, provided it is sustainable based on available information and subject to compliance with specific requirements.

However, class III and implantable medical devices are exceptions. For such products, point 4 specifies the obligation to base the clinical evaluation on a clinical investigation.

Fortunately, there are situations where clinical investigation – and the associated burdens – are avoidable.

Cases where Clinical Investigation is not Mandatory

In order to define the cases of exemption from the requirement applicable to class III and implantable medical devices, two scenarios can be identified:

• The first relates to the placing on the market of new medical devices;
• The second, instead, defines how to treat products already on the market according to 93/42/EEC which, upon expiration of the relevant certificate, will have to be certified according to MDR.

New Product

A manufacturer placing on the market a new medical device that derives from the modification of its own already marketed device, while maintaining equivalence, can avoid clinical investigation.

The same applies to a manufacturer placing on the market a device equivalent to that of a second manufacturer, already marketed. Provided, however, that a contract is stipulated between the two manufacturers that allows the first full continuous access to the technical documentation of the device on which the equivalence is based. This is a critical issue, as they are reasonably competitors.

Product Already on the Market

Clinical investigation is also avoidable for those products already on the market according to 93/42/EEC which, upon expiration of the certificate, will have to comply with the MDR. This is possible provided that the current clinical evaluation is based on sufficient clinical data and that the device complies with any common specifications, if available. Or that such device is included among those mentioned in the list referred to in point 6, paragraph b.

Contract between Competitors

Part of what was said above is the result of our interpretation.
Of Article 61, point 5 is the most controversial. It concerns the obligation of a contract between the parties in case a manufacturer avoids clinical investigation by basing the clinical evaluation on equivalence to an already marketed device of a second manufacturer.

This point, taken by itself, does not directly mention class III medical devices and implantables. Consequently, there has been speculation about the obligation of a contract regardless of the class of the medical device, in all those cases where the clinical evaluation is based on equivalence to third-party products already on the market.

Upon closer reading, it becomes clear (also considering the references and recalls present in the point in question) that this requirement should apply exclusively to class III medical devices and implantables. Otherwise, the competitive relationship between the interested parties would make it practically impossible to base future clinical evaluations on equivalence to other products, forcing clinical investigation.

In conclusion, for all other classes, there are no requirements that impose on the manufacturer the duty to conduct a clinical investigation. Provided, of course, that a clinical evaluation based on existing scientific literature, in light of equivalence with a medical device on the market, is sustainable.