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.

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.

I agree with Wrodnigg.

I would add that the following official interpretations (http://ec.europa.eu/enterprise/medical_devices/guide-stds/interpretative_documents_en.htm) were recently published; these describe what happens for products that simultaneously fall under the MDD and the PPE/Machinery Directives.

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.