Since the European Regulation 745/2017 (MDR) came into force, the recurring question is whether it is necessary to perform a clinical study or whether the clinical evidence already available on the medical device is exhaustive.
But what is meant by comprehensive clinical evidence according to MDR?
The Regulation does not explicitly establish the clinical evidence to be provided and its level of acceptability, but defines it as: "the clinical data and clinical evaluation results relating to a device, in sufficient quality and quantity to allow a qualified assessment of the device's capacity to obtain the expected clinical benefits and safety when used as intended by the manufacturer ". Therefore, despite the perception that the bar for clinical evidence has been raised in the context of the MDR compared to the MDD Directive, the definition of comprehensive clinical evidence has not changed.
So how can manufacturers of MDD compliant medical devices collect comprehensive clinical evidence to ensure compliance with the MDR?
As a first step, it will be necessary to re-evaluate the existing clinical evidence, avoiding immediately jumping to the conclusion that more structured ones are needed, but applying the new legislation together with the guidelines to evaluate the correspondence of each individual medical device to the new paradigms.
Pursuant to Article 61 of the MDR, as it was for MEDDEV 2.7 / 1 Rev.4 in accordance with the MDD Directive, the manufacturer must provide a clinical evaluation to demonstrate compliance with the general safety and performance requirements.
Dwelling on point 3 of Article 61, the clinical evaluation can be based on a critical analysis of the scientific literature with identification of equivalent medical devices already on the market or on an analysis of the results of clinical investigations already performed.
The choice of which route to take is up to the manufacturer, as long as the device is not class III or implantable.
For medical devices belonging to class III or for implantable devices, point 4 of art. 61 of the MDR prescribes the obligation to develop a clinical evaluation based on a clinical investigation.
There are however and, fortunately, exceptions in the event that the medical device is newly placed on the market or is already on the market in accordance with the MDD and must be CE marked according to MDR.
A manufacturer who places on the market a new medical device that derives from the revision of its own device already marketed, while maintaining its equivalence, can avoid clinical investigation.
Similarly, a manufacturer who places on the market a new device, equivalent to that of another manufacturer already marketed, can avoid the clinical investigation if he has access to the technical documentation of the device on which the equivalence is based.
In the case of a medical device already on the market in accordance with the MDD Directive, the clinical investigation can be avoided provided that the clinical evaluation is based on exhaustive clinical data or that the medical device is included among those mentioned in art. 61 point 6, paragraph b.
The MDR Regulation therefore prescribes clinical investigation for class III and implantable medical devices unless the aforementioned exemptions can be applied. For all other classes there are no obligations to conduct a clinical investigation if the clinical evaluation based on research of scientific literature with equivalence with an existing medical device is sustainable.
In all cases the level of time and resources required to define the strategy and planning for the implementation of the requirements of the MDR Regulation should not be underestimated and organizations should be ready for this change which will have a profound impact on several aspects of the product life cycle, starting from the market strategy to be implemented up to the maintenance of the product portfolio. To implement such a complex program, organizations will need strong and steadfast leadership in achieving goals so they can continue to thrive in the increasingly competitive health technology industry.