Clinical evaluations and investigations: Changes ahead in Swiss medical devices laws

Abstract

Companies conducting clinical investigations with medical devices in Switzerland should be particularly aware of the following new requirements to become effective with the Ordinance on Clinical Trials with Medical Devices (ClinO-MD), once adopted in its final form and applicable.This article comments on changes that lie ahead relating to: clinical evaluations, in particular exceptions for equivalence; and to clinical investigations (focusing on: pre-market, post-market, monitoring, protecting personal data, and Eudamed. The draft ClinO-MD is based on Chapter VI of the MDR. The text is largely in alignment with international standards for the conduct of clinical investigations with medical devices set out, inter alia, in ISO 14155:2011 and the Declaration of Helsinki. In the EU, the MDR leaves the Member States with a broad scope of discretion regarding the organisation of the assessment of clinical investigations and the applicable authorisation procedures. Companies conducting clinical investigations with medical devices in Switzerland should be particularly aware of the following new requirements to become effective with the ClinO-MD, once adopted in its final form and applicable. This article comments on changes that lie ahead relating to: clinical evaluations, in particular exceptions for equivalence; and to clinical investigations (focusing on: pre-market, post-market, monitoring, protecting personal data, and Eudamed.