The level of control applied to IVD medical devices reflect the perceived risk associated with each device.
While compliance for the lowest risk (general IVDs) is based on self-declaration by the manufacturer, all other IVDs (self-test IVDs and IVDs listed in Annex II of the IVD Directive) require use of a Notified Body to assess compliance with the Directive.
A number of options or routes to compliance exist under each of the above risk groups. These are outline in Article 9 of the Directive and MHRA has provided further guidance in Bulletin 20 - Conformity Assessment Procedures under the In Vitro Diagnostic Medical Devices Directive 98/79/EC.
