Codes assignment as part of a certification application under Regulation (EU) 2017/745 in accordance with implementing Regulation 2017/2185

Commission Implementing Regulation 2017/2185 establishes the codes assignment MDR framework. This framework defines notified bodies’ scope of designation for medical devices under Regulation (EU) 2017/745. The codes assignment system ensures consistent evaluation and certification across the European Union.

Manufacturers must describe their device type and technology when requesting certification. They must also identify the corresponding codes assignment MDR categories. GMED then determines whether the certification request aligns with our designation codes as a notified body under Regulation (EU) 2017/745.

GMED conducts thorough verification during the codes assignment MDR process. We verify consistency with the device’s design and intended purpose. We also examine the technologies and processes used. Our team reviews each codes assignment MDR submission against the manufacturer’s technical documentation. This ensures alignment with Implementing Regulation 2017/2185 requirements.

This codes assignment MDR guide clarifies the different types of codes. It explains their method of assignment. The guide ensures consistency in codes assigned to each type of medical device. Manufacturers seeking certification under the Medical Device Regulation need to understand the codes assignment MDR methodology.

GMED developed this guide based on MDCG 2019-14. This document is the Explanatory Note on MDR Codes from December 2019. We complemented it with our extensive experience in designation code assignment. GMED has gained this expertise since receiving designation under Regulation (EU) 2017/745. Our codes assignment MDR expertise helps manufacturers navigate device classification and certification complexities.

GMED applies codes assignment MDR principles consistently across all conformity assessments. Our team ensures each codes assignment reflects accurate medical device classification. We follow Implementing Regulation 2017/2185 requirements. This supports manufacturers in achieving compliant CE marking. It enables successful market access throughout the European Union.