As part of its commitment to advancing high-quality patient care and evidence-based genetic testing, the ESHG has submitted its contribution to the European Commission's consultation on the targeted revision of the EU rules governing medical devices and in vitro diagnostics (IVDR).

In its response, the ESHG highlights key considerations from the perspective of clinical laboratory practice and patient access, with the aim of supporting the simplification of the regulatory framework in a way that safeguards safety, fosters innovation, and ensures the continued availability of essential medical technologies.

The full submission is available via the European Commission's "Have Your Say" portal at the link below.
https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/14808-Medical-devices-and-in-vitro-diagnostics-targeted-revision-of-EU-rules/F33464472_en