Clinical evaluation occupies a significant role in the new regulatory framework and appears in several sections of the Medical Device Regulation (MDR).
Among the most complex aspects is the term ‘equivalence’, which – if demonstrated – would exempt manufacturers of high risk devices from performing costly and lengthy clinical investigations. However, certain conditions need to be met. The MDR in fine shrinks the possibility to rely on the ‘’equivalence’’ of clinical data of already marketed devices in the EU.
In general, the ‘equivalence’ is more clearly defined under the MDR than it is under the current Directives and follows the MEDDEV 2.7/rev 4. In particular, Annex XIV of the MDR lays down 3 characteristics that shall be taken into consideration for the demonstration of equivalence:
— Technical: the device is of similar design; is used under similar conditions of use; has similar specifications and properties including physicochemical properties such as intensity of energy, tensile strength, viscosity, surface characteristics, wavelength and software algorithms; uses similar deployment methods, where relevant; has similar principles of operation and critical performance requirements;
— Biological: the device uses the same materials or substances in contact with the same human tissues or body fluids for a similar kind and duration of contact and similar release characteristics of substances, including degradation products and leachables;
— Clinical: the device is used for the same clinical condition or purpose, including similar severity and stage of disease, at the same site in the body, in a similar population, including as regards age, anatomy and physiology; has the same kind of user; has similar relevant critical performance in view of the expected clinical effect for a specific intended purpose.
These characteristics should be similar to the extent that there would be no clinically significant difference in the safety and clinical performance of the device.
‘’Equivalence’’ can also be found in other sections of the MDR, namely when it comes to the:
· PMCF plan, which shall include an evaluation of the clinical data relating to equivalent or similar devices;
· The investigator’s brochure (IB), which shall contain existing clinical data from relevant scientific literature/ other relevant clinical data available relating to the safety, performance, clinical benefits to patients, design characteristics and intended purpose of the device and/or of equivalent or similar devices;