Among the several main innovations news introduced with European Regulation 2017/745 regarding clinical evaluation topic, it is important not to underestimate the stricter standards to be fulfilled by the manufacturers of class III medical devices, from May 2020.
Generally, a clinical investigation is required for a class III device, except the following cases:
- the device has been designed thorough modifications of an already marketed device by the same manufacturer;
- the modified device has been proved equivalent to the marketed device, in accordance with Section 3 of Annex XIV and this demonstration has been endorsed by the notified body, and
- the clinical evaluation of the marketed device is sufficient to demonstrate conformity of the modified device with the relevant safety and performance requirements.
Should all the above conditions be fulfilled, the notified body will just have to to check that the PMCF plan is appropriate and includes post market studies to demonstrate the safety and performance of the device.
A clinical evaluation might be avoided also in case of class III devices: which have been lawfully placed on the market in accordance with Directive 93/42/EEC and for which the clinical evaluation is based on sufficient clinical data. In these cases, the Notified Body is required to check if adequate clinical data are included in the clinical evaluation. However, if the clinical data reported are considered insufficient, the Notified Body can ask for additional clinical data and a clinical investigation may be needed.
Another important innovation is reported in Article 61. According to Article 61, chapter VI, for all class III (and also class IIb) devices, the manufactures are allowed, prior to the relevant clinical evaluation and/or investigation, to consult an expert panel with the aim of reviewing the manufacturer’s intended clinical development strategy and proposals for clinical investigation. The manufacturer shall give due consideration to the views expressed by the expert panel and such consideration shall be documented in the clinical evaluation report.
Based on these points, each class III manufacturer should carefully evaluate the best strategy to be adopted prior to perform the relevant clinical evaluation activities.
Don’t get caught unprepared!
Regulatory Pharma Net is available to support companies for the identification of a proper clinical evaluation approach, as well as, to provide additional information and advice on quality and regulatory aspects to be compliant to the new Regulation 2017/745.