The IVDR redefines and introduces a new conformity assessment for companion diagnostics (CDxs), upclassifying them to class C.
Companion diagnostics now have stricter performance requirements and the need for clinical evidence.
Industry Insights
Industry Insights
The Summary of Safety and Clinical Performance (SSCP) is a new requirement dictated by EU-MDR applicable to implantable devices and class III medical devices, other than custom-made or investigational devices, which will go virtual when EUDAMED becomes fully functional.
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!
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