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Veterinary Devices - CE Marking Categories

M

MDDRegAffairs

#1
Dear all,

I am looking to affix a CE mark to a piezo electric electromechanical actuating device (non-medical) of which the indications for use will be in veterinary services. To the best of my understanding, the applicable CE marks are:

1. 2001/95/EC : General product safety

2. 2006/42/EC : Machinery

3. 2004/108/EC : EMC

4. 85/374 / EEC : Liability for defective products

My questions are:

1. Are these the appropriate applicable directives, and if not, what should be added/removed?

2. How do I identify the appropriate conformity assessment?

3. How can I determine if a notified body is needed; would a notified body involved with medical products of a similar use be appropriate?

Any comments would be greatly appreciated,

Regards,

Tom
 
Elsmar Forum Sponsor
S

Sarah Stec

#2
Re: Veterinary Devices - CE Marking

I'm not sure about your first question, but for your second question, the conformity assessments are in the regulations/directives themselves. The article numbers across the different directives don't correspond (not all Article 17s talk about CE marking, for example) so the information may be in a different place than where it would be in the MDD. But if you go through the Directives, the conformity assessments and when and for which products they apply will be there.

For your third question, whether or not a notified body is needed is also in the regulation/directive. You would use a notified body that's notified to those specific directives. You can figure out which notified bodies are notified to the EMC and Machinery directives on NANDO (http://ec.europa.eu/enterprise/newapproach/nando/index.cfm?fuseaction=directive.main).

Here's a link to where you can figure out if a notified body is needed: http://ec.europa.eu/enterprise/poli...nals/manufacturers/notified-body/index_en.htm

Here's a link to an EU Commission guidance document on the EMC Directive: http://ec.europa.eu/enterprise/sectors/electrical/files/emc_guide__updated_20100208_v3_en.pdf

I hope that this helps. :D
 
M

MDDRegAffairs

#3
Re: Veterinary Devices - CE Marking

Dear Sarah,

Thank you kindly for the detailed response, the information is very helpful.

Regards,

Tom
 

Ronen E

Problem Solver
Staff member
Moderator
#4
Dear all,

I am looking to affix a CE mark to a piezo electric electromechanical actuating device (non-medical) of which the indications for use will be in veterinary services. To the best of my understanding, the applicable CE marks are:

1. 2001/95/EC : General product safety

2. 2006/42/EC : Machinery

3. 2004/108/EC : EMC

4. 85/374 / EEC : Liability for defective products

My questions are:

1. Are these the appropriate applicable directives, and if not, what should be added/removed?

2. How do I identify the appropriate conformity assessment?

3. How can I determine if a notified body is needed; would a notified body involved with medical products of a similar use be appropriate?

Any comments would be greatly appreciated,

Regards,

Tom
Hi Tom,

I believe a lot of answers are in the Blue Guide 2014. If you read the 1st chapter (pp. 6-14 inclusive - not too much) you will get a good handle of your situation. The rest is very informative as well.

Good luck,
Ronen.
 

CharlieUK

Quite Involved in Discussions
#5
Just to add to the above:

85/374 / EEC is not a CE marking Directive

GPSD does not apply to products within scope of Machinery Directive

Also look at RoHS Directive 2011/65/EU and see if your product is within scope.

A Notified Body cannot be used for Machinery unless your product is within Annex IV - and yours is not.

A Notified Body can be used for EMC, but is entirely optional
There a no Notified Bodies for RoHS.

Charlie
 
M

MDDRegAffairs

#6
Ronen,

Thank you for directing my attention toward the Blue Guide, it is a very informative resource.

Tom
 
M

MDDRegAffairs

#7
Charlie,

Thank you for your comments and insight, they are very helpful and much appreciated.

Tom
 
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