Does your device incorporate, as an integral part, a substance which, if used separately, can be considered to be a medicinal product, as defined in point 2 of Article 1 of Directive 2001/83/EC, including a medicinal product derived from human blood or human plasma, as defined in point 10 of Article 1 of that Directive, and that has an action ancillary to that of the devices?

Directive 2001/83/EC, Article 1:
Point 2
Medicinal product:
(a) Any substance or combination of substances presented as having properties for treating or preventing disease in human beings; or
(b) Any substance or combination of substances which may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis.
Point 10
Medicinal products derived from human blood or human plasma: Medicinal products based on blood constituents which are prepared industrially by public or private establishments, such medicinal products including, in particular, albumin, coagulating factors and immunoglobulins of human origin.
EXAMPLES
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Bone cement with antibiotics
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Condoms with spermicide
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Catheters coated with anticoagulants (e. g. heparin)
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Endodontic materials with antibiotics
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Ophthalmic irrigation solutions principally intended for irrigation, which contain components supporting the metabolism of the endothelial cells of the cornea
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Dressings incorporating an antimicrobial agent where the agent has an ancillary action on the wound
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Drug eluting stents (e.g. coronary, pulmonary)
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Surgical sealants containing human serum albumin or thrombin
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Implants coated with human fibrinogen
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Blood bags incorporating heparin or other substances as anticoagulant agents which, if used separately, can be considered to be a medicinal product
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IVF cell media with human albumin2
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Intra Uterine Devices (IUD) containing medicinal substances3 including copper or silver
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Catheter lubrication gels containing analgesia e.g. lidocaine