Industry Insights

ISO 14155:2020 standard has undergone extended revisions in an effort to align with current Regulations/Guidelines mainly pertinent to risk-based monitoring of clinical trials and study design.

This presentation outlines its contents and focuses on the reinforcement of risk management throughout the process of a clinical investigation (Annex H)

On 01 Dec, the first module of EUDAMED on Actors Registration was launched.

EU and non-EU Manufacturers, Authorised Representatives, Importers and System/Procedure Pack Producers acting on the field of both medical devices and invitrodiagnostics can apply for a Single Registration Number (SRN).

IVDR introduces 7 new, risk-based rules and highlights the fact that classification will be defined by the intended purpose.

The recent MDCG 2020-16 Guidance has shed some long-awaited light on the various aspects that need to be considered when classifying an IVD taking into account that >80% IVDs will require up-classification!