Reusable Surgical Instruments | MedTech Compliance Guide

EU requirements

Classification: MDR Annex VIII section 2.3 defines reusable surgical instruments. Rule 6 provides a Class I carve-out for transient surgically invasive reusable surgical instruments that would otherwise default to Class IIa.
Conformity pathway: A Class I reusable surgical instrument requires limited Notified Body involvement for reprocessing and reusability aspects under Article 52(7).

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01Confirm the device meets the Annex VIII section 2.3 definition of a reusable surgical instrument.Source: MDR 2017/745 Annex VIII
02Apply the Rule 6 Class I carve-out and identify the limited Notified Body involvement scope.Source: MDR Article 52
03Validate reprocessing instructions under ISO 17664-1.
04Establish Technical Documentation and a Declaration of Conformity, and assign a UDI.
05Confirm sterilization validation if the device is supplied sterile.

Classification: Reusable surgical instruments may be Class I, exempt, or Class II depending on instrument type and risk.
Conformity pathway: The typical route is Class II 510(k), with validated reprocessing instructions expected in the submission; exempt instruments do not require a 510(k).

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01Determine Class I exempt versus Class II 510(k) status.
02Validate reprocessing instructions under FDA guidance and AAMI TIR12 and TIR30.
03Include reprocessing instructions in labeling under 21 CFR 801.
04Prepare a 510(k) submission if the device is not exempt.
05Establish a DHF and QMSR-aligned quality system.Source: FDA QMSR