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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?

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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

  • Bone cement with antibiotics

  • Condoms with spermicide

  • Catheters coated with anticoagulants (e. g. heparin)

  • Endodontic materials with antibiotics

  • Ophthalmic irrigation solutions principally intended for irrigation, which contain components supporting the metabolism of the endothelial cells of the cornea

  • Dressings incorporating an antimicrobial agent where the agent has an ancillary action on the wound

  • Drug eluting stents (e.g. coronary, pulmonary)

  • Surgical sealants containing human serum albumin or thrombin

  • Implants coated with human fibrinogen

  • Blood bags incorporating heparin or other substances as anticoagulant agents which, if used separately, can be considered to be a medicinal product

  • IVF cell media with human albumin2

  • Intra Uterine Devices (IUD) containing medicinal substances3 including copper or silver

  • Catheter lubrication gels containing analgesia e.g. lidocaine

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