Declaration of Conformity - Conformance with more than one directive

[temujin]

Dear Cove,

When writing the Declaration of Conformity for electromedical equipment is it enough to state conformance with the Medical Directive 93/42/EEC? (or the IVDD respectively)?

Do I need to explicitly state conformance with the directive for e.g. electromagnetic compatibility (2004/108/EC), or is this already implicit in the confomance to MDD?

I know I have read something about this before, however, as I am now in the process of issuing the DoC, I was hoping for a quick answer here...

best regards and thanks
t.

[wrodnigg]

It depends

Seriously: For (active) medical devices (Medical electrical equipment) the regulations are the following:

Article 1(7) of the MDD (which I have posted on Wednesday, but it is also stipulated this way in the old one) reads:

This Directive is a specific Directive within the meaning of
Article 1(4) of Directive 2004/108/EC of the European Parliament and
of the Council (2).

This means that the essential requirements of the directive 2004/108/EC are included in the 93/42/EEC MDD.

Lets take a look into Article 1(4) 2004/108/EC (2):

4. Where, for the equipment referred to in paragraph 1, the
essential requirements referred to in Annex I are wholly or
partly laid down more specifically by other Community directives,
this Directive shall not apply, or shall cease to apply, to
that equipment in respect of such requirements from the date
of implementation of those directives.

Therefore you have to fulfill the essential requirements of Annex I MDD, which includes the applicable requirements from 2004/108/EC (covered by MDD Annex I, Clause 12.5.). Requirements are written in detail in the harmonized standard EN 60601-1-2.

The Declaration of conformity only mentions the 93/42/EEC, but you should mention the harmonized standard EN 60601-1-2, and the instructions for use have to include the required tables.

Only if the device is an laboratory apparatus (EN/IEC 61010-1) and NOT a medical device or IVD (here the regulations are similar in 98/79/EC), the 2004/108/EC has to be applied.

[Roland Cooke]

I agree with Wrodnigg.

I would add that the following official interpretations were recently published; these describe what happens for products that simultaneously fall under the MDD and the PPE/Machinery Directives.

[JustinP]

Hello temujin,
it always depends on the answer to the question: Is it a medical device or not? If not, you can declare the conformity to the low voltage directive, otherwise declaring the conformity to the mdd is necessary.

Justin.

[Watchwait]

Originally Posted by wrodnigg

The Declaration of conformity only mentions the 93/42/EEC, but you should mention the harmonized standard EN 60601-1-2, and the instructions for use have to include the required tables.

Wrodnigg: Could you please clarify which "required tables" need to be included in the instructions for use and which standard or directive established this specific requirement?

[Sandor C.]

Hello,

may I extend the discussion to a different but similar aspect:
A quality assurance device of a linear accelerator is a medical device according to the MDD because it is an accessory of the linac.
Since it used before or after the patient treatment, patient contact of the device can never occur. Therefore the IEC 60601-1 standard which is harmonised to the MDD cannot be applied because the device is outside the scope of the standard.
The standard which seems to cover the device by its scope is the IEC 61010.
To my opinion it might be reasonable that a device complies with a standard which is not harmonised although a harmonised standard exists, when the scope matches accordingly.
What do you think?
Do you have similar examples or experience?
How is the legal situation in USA and Canada?

Thank you for answering

Kind regards
Sandor

[Persson]

Originally Posted by temujin

Dear Cove,

When writing the Declaration of Conformity for electromedical equipment is it enough to state conformance with the Medical Directive 93/42/EEC? (or the IVDD respectively)?

Do I need to explicitly state conformance with the directive for e.g. electromagnetic compatibility (2004/108/EC), or is this already implicit in the confomance to MDD?

I know I have read something about this before, however, as I am now in the process of issuing the DoC, I was hoping for a quick answer here...

best regards and thanks
t.

If your device is covered by more than one CE-marking related directives, you can use a single Declaration of Conformity with proper wording to cover the requirements of all the relevant directives.

Here is an official model for EC Declaration of Conformity-
http://elsmar.com/Forums/showthread.php?t=23799

[Watchwait]

Originally Posted by temujin

Dear Cove,

When writing the Declaration of Conformity for electromedical equipment is it enough to state conformance with the Medical Directive 93/42/EEC? (or the IVDD respectively)?

Do I need to explicitly state conformance with the directive for e.g. electromagnetic compatibility (2004/108/EC), or is this already implicit in the conformance to MDD?

.

I have some recent experience exactly in this area...

Our Class IIa active medical device has a DoC that reflects only conformance to 93/42/EEC. Originally, the DoC cited this standard, plus the appropriate 60601-x-x harmonized standards. At our initial inspection, our Notified Body told us to remove reference to the harmonized standards and only retain a reference to 93/42/EEC.

So we did - and so we remain!