Sääntelysuunnitelma

Sääntelysuunnitelma markkinoille pääsyyn

When planning on bringing a medical device to the market, a company needs to create a regulatory plan to define the regulatory framework (including standards and guidance) as well as the conformity assessment procedure applicable for the device.

The conformity assessment procedure determines the actions and documentation needed for the regulatory submission of the device as well as the requirements
for the quality management system under which the device is developed and manufactured.

Conformity assessment procedures are set out in Article 52 and Annexes IX to XI of MDR (2017/745), and in Article 48 and Annexes IX to XI of IVDR (2017/746).

The applicable conformity assessment procedure depends on the type and risk class of the device, both of which need to be defined in the regulatory plan.