Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) establish the requirements for sampling of Class IIa/ Class IIb and Class B / Class C devices for the assessment of the technical documentation.
Article 52(4) and (6) of the MDR and Article 48(7) and (9) of the IVDR establish the need to assess the technical documentation of at least one representative device per generic device group (for Class IIb and Class C) and for each category of devices (for Class IIa and Class B) prior to issuing the certificate.
Section 2.3 and 3.4 of Annex IX of both Regulations (and section 10 of Annex XI of the MDR) defines that the quality management system assessment has to be accompanied by the assessment of technical documentation for devices selected on a representative basis.
Section 4.5.2(a) of Annex VII of both Regulations requires the notified body to draw up and keep up to date, a sampling plan for the assessment of technical documentation as referred to in Annexes II and III prior to the audit.
Section 4.5.2(b) of Annex VII requires the notified body to assess the technical documentation as preparation for the audit(s). This assessment is expected to be finalised in due time of such audit(s).
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…