October 01, 2020 - October 01, 2020
Date: 1st of October 2020
Time: 16:00h - 16:30h CEST
Clinical data related to medical devices may come from different sources, e.g. clinical investigations, post-market activities, or the scientific literature. Whereas a clinical evaluation is designed to collect and analyse all these data sources, the Medical Device Regulation 2017/745 foresees situations in which data related to an equivalent device or a benchmark device considered representative of the current state of the art may be used to demonstrate conformity of a device under evaluation with the General Safety and Performance Requirements (GSPRs).
Whether or not the use of such “Equivalence Pathway” is possible will depend, among others, on
- the device class,
- the similarity between the device under evaluation and the equivalent device in terms of clinical, technical and biological characteristics,
- the availability of sufficient clinical data, and
- the level of access to the technical documentation of the equivalent device.
The webinar will analyse all these circumstances to determine whether the equivalence pathway may be used in accordance with MDR 2017/745, MEDDEV 2.7/1 rev 4 and the recently published MDCG guideline 2020-5.
An example from the field of ophthalmology will be given on how to demonstrate equivalence between two class IIb devices (implants), how to identify clinically relevant differences and how to address them in the clinical evaluation using applicable standards (ISO norms) and the scientific literature.
Attendees will be able to:
- Design a clinical evaluation strategy for any device class in compliance with MDR and MEDDEV,
- Build an argumentation that allows the use of clinical data from an equivalent device, if applicable, to demonstrate conformity with the GSPRs,
- Use available non-clinical and clinical data in a wise way to avoid generation of unnecessary data, and
- Determine PMCF activities required to close data gaps.
Who should attend:
Clinical and regulatory personnel working at a medical device manufacturer who are involved in the preparation or assessment of clinical evaluations.