E
evilchilli_420
Hello everyone,
I was reading the definitions in the MDD and was confused by a few terms. I do not have any experience with combination products and would appreciate if anyone explain the following terms with an example, if possible?
3. Where a device is intended to administer a medicinal product within the meaning of Article 1 of Directive 2001/83/EC (1), device shall be governed by this Directive, without prejudice to the provisions of Directive 2001/83/EC with regard to the medicinal product.
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 2001/83/EC. The relevant essential requirements of Annex I to this Directive shall apply as far as safety and performance-related device features are concerned.
4. Where a device incorporates, as an integral part, a substance which,
if used separately, may be considered to be a medicinal product within the meaning of Article 1 of Directive 2001/83/EC and which is liable to act upon the body with action ancillary to that of the device, that device shall be assessed and authorized in accordance with this Directive.
4 a. Where a device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product constituent or a medicinal product derived from human blood or human plasma within the meaning of Article 1 of Directive 2001/83/EC and which is liable to act upon the human body with action ancillary to that of the device, hereinafter referred to as a ?human blood derivative?, that device shall be assessed
and authorized in accordance with this Directive.
Thanks in advance.
I was reading the definitions in the MDD and was confused by a few terms. I do not have any experience with combination products and would appreciate if anyone explain the following terms with an example, if possible?
3. Where a device is intended to administer a medicinal product within the meaning of Article 1 of Directive 2001/83/EC (1), device shall be governed by this Directive, without prejudice to the provisions of Directive 2001/83/EC with regard to the medicinal product.
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 2001/83/EC. The relevant essential requirements of Annex I to this Directive shall apply as far as safety and performance-related device features are concerned.
4. Where a device incorporates, as an integral part, a substance which,
if used separately, may be considered to be a medicinal product within the meaning of Article 1 of Directive 2001/83/EC and which is liable to act upon the body with action ancillary to that of the device, that device shall be assessed and authorized in accordance with this Directive.
4 a. Where a device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product constituent or a medicinal product derived from human blood or human plasma within the meaning of Article 1 of Directive 2001/83/EC and which is liable to act upon the human body with action ancillary to that of the device, hereinafter referred to as a ?human blood derivative?, that device shall be assessed
and authorized in accordance with this Directive.
Thanks in advance.