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CE Marking - RTTE Directive & IVD Directive

M

mentor09

#1
Hi all
Wondering if anyone can assist. If I have an IVD device that contains Bluetooth technology do I need to Obtain CE certification for both directives? If so does this mean 2 CE files and 2DoCs or can both directive essential principles be covered by one CE File?...Does the RTTE directive (99/5/EC) apply for IVDs? Any advice most welcome... :)
 

sreenu927

Quite Involved in Discussions
#2
Re: CE marking: RTTE directive & IVD Directive

Hi mentor09,

If your product is an IVD, then IVD Directive is "THE" Directive, you must comply with and draw an EC DoC following the IVD directive. If blue tooth technology is involved, then appropriate Directives are to be followed as part of conforming to the Essential principles (EP) of IVD Directive. Similarly, if your product requires to follow the Low Voltage (LVD or Product Safety) and EMC Directives, your appropriate EP must comply with those directives.
For the case of EMC and LVD, you have to have a technical file for that directive to submit to the testing services lab to get the Safety markings on your product label. But to the European Notified Bodies, you will submit the European Technical File to comply with the EP of IVD Directive to obtain CE Marking. So the Bluetooth/LVD/EMC Directives (or technical files) will be sub-set of your EU PRODUCT (IVD) TECHNICAL FILE.

Hope this helps!

Regards,
Sreenu
 

CharlieUK

Involved In Discussions
#3
Re: CE marking: RTTE directive & IVD Directive

The R&TTE Directive needs to be applied in full, irrespective of IVD - they are independent of one another

R&TTE Directive compliance can be fully achieved without using a Notified Body as there are appropriate standards for articles 3.1a, 3.1b and 3.2 that are applicable for Bluetooth
 

CharlieUK

Involved In Discussions
#5
RED is replacing R&TTE in 2016, but with the exception of Telecommunication Terminal Equipment (phones, facsimiles etc.) all products within scope of R&TTE will move into RED with similar requirements.

The main changes are related to NLF alignments and add requirements for importers, distributors and others in the supply chain.
 
T

ThomasLee

#6
I agree RED is replacing R&TTE in 2016 and until 2017 you are still allowed to use R&TTE instead of RED.
Can you apply RED also for today's products in 2015 already?
 

CharlieUK

Involved In Discussions
#7
>Can you apply RED also for today's products in 2015 already?

No - you cannot use the RED until 13 June 2016 - as per article 49.

Charlie
 

QAengineer13

Quite Involved in Discussions
#8
The R&TTE Directive 1999/5/EC has been repealed on June 13,2016 . However, the RED stipulates a transition period of one year from the date of adoption, which gives the following dates for when manufacturers should use either directive in their Declaration of Conformity:

• Products placed on the market before June 13, 2016: R&TTE
• Products placed on the market between June 13, 2016 and June 12, 2017: R&TTE or RED
• Products placed on the market after June 12, 2017: RED
 
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