Biomedical Engineering Reference
In-Depth Information
7.4.4
Regulation of combination products in the European
Union
Similar to the approval process in the United States, the first step in determining the
European regulatory requirements for a medicinal product-delivery vehicle com-
bination is to determine the product designation. According to the Medical Device
Directive (MDD), Council Directive 93/42/EEC, June 14, 1993
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' “medical device” means any instrument, apparatus, appliance, material
or other article, whether used alone or in combination, including the
software necessary for its proper application intended by the manufac-
turer to be used for human beings for the purpose of:
• diagnosis, prevention, monitoring, treatment or alleviation of disease,
• diagnosis, monitoring, treatment, alleviation of or compensation for an
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.'
Article 1(3) of the MDD addresses the governance of devices intended to admin-
ister medicinal products:
'Where a device is intended to administer a medicinal product within the
meaning of Article 1 of Directive 65/65/EEC,
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that device shall be
governed by the present Directive.
If, however, such a device is placed on the market in such a way that the
device and the medicinal product form a single integral product which is
intended exclusively for use in the given combination and which is not
reusable, that single product shall be governed by Directive 65/65/EEC
(concerning medicinal products). The relevant essential requirements of
Annex I to the present directive shall apply as far as safety and perform-
ance related device features are concerned.'
Further guidance on the designation of combination products can be found in the
European Commission guidelines relating to the demarcation between active
implantable medical devices, medical devices and medicinal products (MEDDEV
2.1/3 Rev 5.1 - March 1998).
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When a medical device is used to deliver a
medicinal product, the combination will typically be regulated as a medicinal
product.
