December 11th, 2019, the Medical Device Coordination Group (MDCG) released two new guidance documents. MDCG 2019-13 provides guidance on sampling of MDR Class IIa / Class IIb devices and IVDR Class B / Class C devices for the assessment of the technical documentation and MDCG 2019-14 is an explanatory note on MDR codes.
MDCG 2019-13 defines the requirements of sampling and further elaborates on the sampling criteria and use of such criteria for drawing up and maintaining a sampling plan. The guidance includes definitions, specifics on sampling criteria such as sampling prior to the issuance of quality management system (QMS) certificates, sampling during surveillance and qualitative sampling criteria. It also offers more information on the assessment of the technical documentation, such as depth and reporting.
MDCG 2019-14 is intended to explain the different level of MDR codes, established by Commission Implementing Regulation 2017/2185, and how they should be used.
What does this mean to you?
All manufacturers should carefully read the MDCG 2019-13 to understand how to define categories of devices (MDR class IIa / IVDR class B) and how to define generic device groups (MDR class IIB / IVDR Class C). This guidance also provides information on how the sampling of technical documentation will be organised and what to expect in terms of depth and extent of review. It also allows you to understand what to expect of a sampling plan.
Should you want to discuss this more in depth with one of our consultants, please do not hesitate to get in touch with us.
