The European regulation 2017/745, that will entry into force in May 2020, introduces several new elements with an impact on many aspects of the medical device field, including the clinical evaluation.
Chapter VI and Annex XIV of the European regulation 2017/745 are dedicated to the clinical evaluation.
One of the most interesting change concerns the requirements which have to be fulfilled for demonstrating the equivalence between two different devices.
In this regard, according to Article 61 of the new Regulation, a manufacturer can demonstrated that a device is equivalent to an already marketed one, provided that the following conditions are met:
- the two manufacturers have entered into a contract expressly allowing the manufacturer of the second device full access to the technical documentation;
- the original clinical evaluation has been carried out in compliance with the requirements of the new Regulation, and the manufacturer of the second device provides clear evidence of this to the notified body.
The technical, biological and clinical characteristics that shall be considered for the demonstration of equivalence are described in the Annex XIV:
- Technical characteristics: the device has similar design, specifications and physic-chemical properties and it is used under similar conditions of use.
- Biological characteristics: the device uses the same materials or substances in contact with the same human tissues and it has similar duration and release characteristics of the substances, including degradation products and releasable substances.
- Clinical characteristics: the device is used for the same clinical indication or purpose, including similarity of severity and stage of disease and it has the same type of users and range of population. Furthermore, it must offer a similar performance in view of the clinical effects expected for a specific intended use.
If all these requirements are fulfilled, the manufacturer may avoid carrying out a clinical investigation on the device.
This may have a great impact on the company’s activities, as there are many devices whose clinical evaluations are based on the demonstration of the equivalence with other devices. Therefore, manufacturer should carefully check and plan all the needed activity to be compliant with the new regulation.
Don’t get caught unprepared!
Regulatory Pharma Net is available to support companies for the identification of a proper clinical evaluation strategy, as well as, to provide additional information and advice on quality and regulatory aspects to be compliant to the new Regulation 2017/745.