MDCG 2019-13 Guidance on sampling of MDR Class IIa / Class IIb and IVDR Class B / Class C devices for the assessment of the technical documentation
This guidance is intended to define the requirements of sampling for Class IIa and Class IIb devices under the MDR and Class B and Class C devices under the IVDR for the purpose of assessing the technical documentation. This guidance defines and further elaborates on the sampling criteria and use of such criteria for drawing up and maintaining a sampling plan.
In addition, this guidance clarifies the tasks to be performed by the notified body including the applicability of Chapter II of Annex IX of both Regulations and the extent of the technical documentation assessment.
See Section 5.3 for exemptions for specific types of devices