Framework
EUIVDR — Market Access
The EU IVDR 2017/746 defines the requirements for placing IVD medical devices on the European market, including conformity assessment procedures, CE marking, and the EU declaration of conformity. It establishes a risk-based classification system (Classes A, B, C, D) that determines the conformity assessment route, the involvement of notified bodies, and the regulatory obligations of manufacturers.
Overview
Background
Regulation (EU) 2017/746 replaced the IVD Directive (98/79/EC) with a fundamentally different market access framework. The most significant change was the introduction of a risk-based classification system, replacing the directive's list-based approach. This shifted the majority of IVD devices from self-certification to notified body involvement, significantly increasing regulatory oversight of the IVD sector.
Applicability
These requirements apply to manufacturers, authorized representatives, importers, and distributors of IVD medical devices intended for the EU market. The conformity assessment route depends on the device risk classification (Class A, B, C, or D). All devices must bear CE marking and be accompanied by an EU declaration of conformity. Class B, C, and D devices require notified body involvement.