Device deficiency

Device deficiencies must be recorded even when no one was harmed, including use errors and inadequate instructions. Some deficiencies that could have led to serious harm are reportable in a clinical investigation.

‘device deficiency’ means any inadequacy in the identity, quality, durability, reliability, safety or performance of an investigational device, including malfunction, use errors or inadequacy in information supplied by the manufacturer;

EU MDR, Article 2(59)

‘device deficiency’ means any inadequacy in the identity, quality, durability, reliability, safety or performance of a device for performance study, including malfunction, use errors or inadequacy in information supplied by the manufacturer;

IVDR, Article 2(62)

inadequacy of a medical device (3.34) with respect to its identity, quality, durability, reliability, usability, safety, or performance Note 1 to entry: Device deficiencies include malfunctions (3.33), use errors (3.53), and inadequacy in the information supplied by the manufacturer including labelling. Note 2 to entry: This definition includes device deficiencies related to the investigational medical device (3.29) or the comparator (3.12).

ISO 14155:2020, clause 3.19

The MDR applies the term to an investigational device in a clinical investigation, and the IVDR to a device for performance study.