Medical Device Directive 93/42/EEC definitions help

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.
 

Ronen E

Problem Solver
Moderator
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.

Hi,

It's as clear as mud.

In general, a combination device is governed by the MDD + the medicinal ingredient is also subject to the applicable provisions in the MPD (Medicianl Product Directive).

As an exception, when the device is provided with the medicinal ingredient already loaded, can't be used in any other way, and is not reusable - only the MPD applies + relevant ERs in the MDD (those that apply to safety and performance of the non-medicinal parts of the device). Example: One-time Epipen injector.

When the intended action of the medicinal product (including derivatives of human blood and plasma) is only ancillary to the combination device intended use, the MDD is the governing directive. Example: (some) Drug eluting stents.

Cheers,
Ronen.
 
S

Sarah Stec

MEDDEV 2.1/3 Rev. 3 might be of help for you in parsing out the different terms and what they mean, like "integral to" and others. I'm not sure if a link will work, but if you internet search for the MEDDEV cite, then it'll pop up.
 
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