Agreeing with Elizabeth and Rachel.
Another thing to consider - what testing is required for your device? Depending on how the radio equipment is incorporated, you may have to perform testing for the device as a whole to confirm that it is in compliance with the directive.
Consider it this way: When designing a device which uses electricity, components are usually chosen for which electrical safety testing has been performed. However, the device will still undergo at least some electrical safety testing, because the components, assembled together, within the rest of the device may present different risk profiles than the individual components. The risks associated with the system are what must be considered, unless the radio equipment is substantially isolated from the system.
If you are still early in design phase, it could help to discuss this with a test lab to learn what configurations might trigger different degrees of testing requirments. It's possible some configurations will be less burdensome than others.
------------------------------
Joanne Pelaschier RAC,PHD
Sr. Regulatory Specialist
Milpitas CA
United States
------------------------------
Original Message:
Sent: 10-May-2017 04:36
From: Rachel Gauntlett
Subject: Radio Equipment Directive
Hi there,
In my reading of the RED, it's stronger than that. Here is an extract from the RED itself:
(42) To ensure effective access to information for market surveillance purposes, the information required to identify all applicable Union acts should be available in a single EU declaration of conformity. In order to reduce the administrative burden on economic operators, that single EU declaration of conformity may be a dossier made up of relevant individual declarations of conformity.
And from Article 18:
3.Where radio equipment is subject to more than one Union act requiring an EU declaration of conformity, a single EU declaration of conformity shall be drawn up in respect of all such Union acts. That declaration shall contain the identification of the Union acts concerned including their publication references.
i.e. you are obliged to have a single DoC listing all the applicable directives to which the device is subject.
Regards,
R
------------------------------
Rachel Gauntlett
Oxfordshire
United Kingdom
------------------------------
Original Message:
Sent: 09-May-2017 18:50
From: Elizabeth Goldstein
Subject: Radio Equipment Directive
Hi,
I am guessing that you are asking whether you have to maintain separate DOCs if your product is required to comply with multiple directives, for example the MDD and RED - is that correct?
My understanding is that you can use a single DOC for the product as long as you state which directives you are declaring conformance with. However it may be of value to have a chat with your NB to make sure you use a format which makes sense to both of you (I have seen NB requests for clarification on how information is presented in a DOC).
Here are some references that may be of interest to you:
I hope that helps!
Liz
------------------------------
Elizabeth Goldstein RAC
Regulatory Affairs Specialist
Medtronic Vascular
Santa Rosa CA
United States
------------------------------
Original Message:
Sent: 08-May-2017 20:28
From: Anonymous Member
Subject: Radio Equipment Directive
This message was posted by a user wishing to remain anonymous
As part of the RED, is it mandatory to have a separate DoC issued for supply of the radio equipment?