Essentials of European Medical Device Regulatory Affairs

Currently - 18 rules

Rules 1 - 4

Non-invasive devices

Rules 5 - 8

Invasive devices

Rules 9 – 12 Active devices

Rule 13- 18 Special rules

http://ec.europa.eu/DocsRoom/documents/10337/attachments /1/translations

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Example: Rule 6 Surgically invasive devices - transient use - Class IIa unless: • Intended to control, diagnose, monitor or correct defect of the heart or of the central circulatory system through direct contact -Class III (angioplasty balloon catheters) • Reusable surgical instruments - Class I (scalpels) • Intended for direct contact with the central nervous system - Class III (brain spatulas) • To supply energy in the form of ionising radiation - Class IIb • Intended to have a biological effect or to be absorbed - Class IIb • Intended to administer medicines by means of a delivery system, if in a potentially hazardous manner - Class IIb

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