Chapter 18 Regulations Tracking

Regulations US: FDA, almost all devices, almost all drugs European Community: devices so far, CE mark is the goal. –Active implantable medical devices (1993) –In-vitro Diagnostic Medical Devices Directive (1997) –EFTA 380 million

US Standards Regulatory – law based National voluntary consensus –IEEE, ASME, ANSI, ISO, … Foreign national International

Medical Device Directives “any instrument, appliance, apparatus, material or other article, whether used alone or in combination, including the software necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:

–Diagnosis, prevention, monitoring, treatment or alleviation of disease –Diagnosis, monitoring alleviation or compensation for injury or handicap –Investigation, replacement or modification of the anatomy or of a physiological process –Control of conception; And which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means”

Medical Device Directives: Active Implantable Medical Device – depends on power source other than human body, which is partially or totally inserted, which remains after the procedure, … Medical Device Directive (all not above or below) In Vitro Medical Device – reagents, calibrator, instrument, dx valoue

General requirements for devices Safe, low risk Perform re specs Safe throughout lifetime of device Safe in environments, transport, etc High benefits/risk

Specific requirements for devices Chemical, physical, bio pptys Infection, sterilization Construction, environmental propoerties Measurement reliability Hazard mitigation …checklists…

Notified Body Independent judge of device… Competent judge of device… Trained, experienced staff Integrity Impartial … Lloyds of London

Job description Audit, examine, survey, verify,attest, certify, communicate results, act as gatekeeper if errors found, … Certify declaration of conformity, which allows CE mark…

ISO 9000 General listing of overall requirement that must be met for documentation of devices. Specific levels for device type. Data required includes design control, QSR, servicing, etc…

Other major players Canada – somewhat between US & EU Pacific Rim – tending toward EU