The level of control applied to medical devices reflect the perceived risk associated with each device, as related to the product's classification.
While compliance for the lowest risk class is based on self-declaration by the manufacturer, all other devices 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 and are listed under Article 11 of the Directive. Guidance is also available in MHRA's Bulletin 4 on Conformity Assesment Procedures.
