MDCG 2019-13 MDR lla类 Ilb类和IVDR B类 C类器械取样指南，用于技术文件的评估.pdf

Medical Device Medical Device Coordination Group Document MDCG 2019-13 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 December 2019 This document has been endorsed by the Medical Device Coordination Group (MDCG) established by Article 103 of Regulation (EU) 2017/745. The MDCG is composed of representatives of all Member States and it is chaired by a representative of the European Commission. The document is not a European Commission document and it cannot be regarded as reflecting the official position of the European Commission. Any views expressed in this document are not legally binding and only the Court of Justice of the European Union can give binding interpretations of Union law. 1 Guidance on sampling of MDR Class IIa / Class IIb and IVDR Class B / Class C devices for the assessment of the technical documentation 1 Introduction 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 as