If an apparatus is not a radio transmitter, but may be or will be incorporated into a radio transmitter, can it be CE marked via Annex II?

If an apparatus is not a radio transmitter, but may be or will be incorporated into a radio transmitter, can it be CE marked via Annex II?

I would have liked to know more about the "apparatus" in order to be more sure, but the below is of the top of my head:

As far as I am able to see there should be no problem CE marking the the "apparatus" under Annex II: Provided of course that you hold a current QMS certification, that the proper documentation for the apparatus has been gathered, and it has been developed and tested using known standards for the product. I don't think any of that will be an issue for you :cool:

Depending on the class of product you are producing Annex II states that you have to have the product file scrutinized before CE-marking by your notifying body if it is a Class 3 but not Class 2a and 2b (§7) which is "only" subjected to audits.

Hope it helps :bigwave:

I would have liked to know more about the "apparatus" in order to be more sure, but the below is of the top of my head:

As far as I am able to see there should be no problem CE marking the the "apparatus" under Annex II: Provided of course that you hold a current QMS certification, that the proper documentation for the apparatus has been gathered, and it has been developed and tested using known standards for the product. I don't think any of that will be an issue for you :cool:

Depending on the class of product you are producing Annex II states that you have to have the product file scrutinized before CE-marking by your notifying body if it is a Class 3 but not Class 2a and 2b (§7) which is "only" subjected to audits.

Hope it helps :bigwave:The product is a frequency converter and has been tested by an independent testing organization. We have a Quality System registered to ISO 9001. I didn't see any reference to a Notified Body in Annex II.
ANNEX II


CONFORMITY ASSESSMENT PROCEDURE REFERRED TO IN ARTICLE 10(3)

Module A (internal production control)


1. This module describes the procedure whereby the manufacturer or his authorised representative established within the Community, who carries out the obligations laid down in point 2, ensures and declares that the products concerned satisfy the requirements of this Directive that apply to them. The manufacturer or his authorised representative established within the Community must affix the CE marking to each product and draw up a written declaration of conformity.

2. The manufacturer must establish the technical documentation described in point 4 and he or his authorised representative established within the Community must keep it for a period ending at least 10 years after the last product has been manufactured at the disposal of the relevant national authorities of any Member State for inspection purposes.

3. Where neither the manufacturer nor his authorised representative is established within the Community, the obligation to keep the technical documentation available is the responsibility of the person who places the product on the Community market.

4. The technical documentation must enable the conformity of the product with the essential requirements to be assessed. It must cover the design, manufacture and operation of the product, in particular:
- a general description of the product,
- conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc.,
- descriptions and explanations necessary for the understanding of said drawings and schemes and the operation of the product,
- a list of the standards referred to in Article 5, applied in full or in part, and descriptions and explanations of the solutions adopted to meet the essential requirements of the Directive where such standards referred to in Article 5 have not been applied or do not exist,
- results of design calculations made, examinations carried out, etc.,
- test reports.

5. The manufacturer or his authorised representative must keep a copy of the declaration of conformity with the technical documentation.

6. The manufacturer must take all measures necessary in order that the manufacturing process ensures compliance of the manufactured products with the technical documentation referred to in point 2 and with the requirements of this Directive that apply to them.


Is this the latest version?

Well, talk about useless feedback. My apologies!!

Point one: The documentation should be OK, I am not used to a retention period of lifetime + 10 years, but I suppose you are, and that it is specified in your documentation procedure.

Point two: A good technical file should be present, and I presume it is.

Point three: The standards should be partly described in the file, and partly in the assessment you have received from the independent testing organization.

I am not able to say anything to indicate that Annex II should not be used as a basis of approval. I believe that it should be OK to do so.

Well, talk about useless feedback. My apologies!!

Point one: The documentation should be OK, I am not used to a retention period of lifetime + 10 years, but I suppose you are, and that it is specified in your documentation procedure.

Point two: A good technical file should be present, and I presume it is.

Point three: The standards should be partly described in the file, and partly in the assessment you have received from the independent testing organization.

I am not able to say anything to indicate that Annex II should not be used as a basis of approval. I believe that it should be OK to do so.My greatest concern is in regards to a Notified Body. The product is in a ground based satellite communications system and is what's known as a Block Up Converter (http://en.wikipedia.org/wiki/Block_upconverter) (self contained). It is used to convert the IF frequency from a modem to the RF frequency, which is then fed to a power amplifier and then transmitted to the satellite.

My greatest concern is in regards to a Notified Body. The product is in a ground based satellite communications system and is what's known as a Block Up Converter (http://en.wikipedia.org/wiki/Block_upconverter) (self contained). It is used to convert the IF frequency from a modem to the RF frequency, which is then fed to a power amplifier and then transmitted to the satellite.

This is proving to be challenging :)

I have been reading through the directive, and I believe that your hurdle may be:

Article 10
Conformity assessment procedures

1. The conformity assessment procedures identified in this Article shall be used to demonstrate the compliance of the apparatus with all the relevant essential requirements identified in Article 3.

2. At the choice of the manufacturer, compliance of the apparatus with the essential requirements identified in Article 3(1)(a) and (b) may be demonstrated using the procedures specified in Directive 73/23/EEC and Directive 89/336/EEC respectively, where the apparatus is within the scope of those Directives, as an alternative to the procedures laid out below.

3. Telecommunications terminal equipment which does not make use of the spectrum allocated to terrestrial/space radio communication and receiving parts of radio equipment shall be subject to the procedures described in any one of Annexes II, IV or V at the choice of the manufacturer.

4. Where a manufacturer has applied the harmonised standards referred to in Article 5(1), radio equipment not within the scope of paragraph 3 shall be subject to the procedures described in any one of Annexes III, IV or V at the choice of the manufacturer.

5. Where a manufacturer has not applied or has only applied in part the harmonised standards referred to in Article 5(1), radio equipment not within the scope of paragraph 3 of this Article shall be subject to the procedures described in either of Annexes IV or V at the choice of the manufacturer.

6. Records and correspondence relating to the conformity assessment procedures referred to in paragraphs 2 to 5 shall be in an official language of the Member State where the procedure will be carried out, or in a language accepted by the notified body involved.

I believe that you may be in a situation where points 4 and 5 have come into play, it does not sound to me as if point 3 is applicable. If I am correct in this assumption, then Annex II does not seem to be applicable. However, you should be able to apply Annex III - provided of course that a) you are certified to an internationally accepted standard, and b) that you have applied the harmonised standards for development and testing.

The requirement most important to your worry about Notifying Bodies, in this case - as I read the directive - is to have the documentation present and legible in a language that is acceptable to the Notifying Body. No presubmission but the file can be inspected during an audit (Article 10.6).