Essentials of European Medical Device Regulatory Affairs

Classification of medical devices Classification criteria Duration of contact MDR Annex VIII • Transient: < 60 minutes • Short term: 60 minutes ≤ 30 days • Long term: > 30 days - Immediate replacement by similar device is a continuation of original use

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Classification of medical devices Classification criteria

Degree of invasiveness (1) • Surgically Invasive Device

- an invasive device which penetrates inside the body through the surface of the body, including through mucus membranes of body orifices with the aid or in the context of a surgical operation - a device which produces penetration other than through a body orifice • Body orifice - natural opening in the body, as well as the external surface of the eyeball, or any permanent artificial opening, such as a stoma

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