Essentials of European Medical Device Regulatory Affairs - October 2019
Integral Products (which are medicines)
Examples:-
• Prefilled syringes/pens • Aerosols containing a medicinal substance • Pre-charged nebulizers • Implants that release a medicinal product • Patches for transdermal drug delivery
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Integral Products (which are devices)
Definition:-
Device that incorporates, as an integral part, a substance .. if used separately, may be considered .. a medicinal product .. and which is liable to act on the body with action ancillary to that of the device
Regulated as device: 93/42/EEC article 1(4)
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