Declaration of Conformity - MDD (Medical Device Directive) 2007/47/EC or 93/42/ECC

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Russbigbelly

Hello,

New to the forum...:) I am currently tidying up a technical file for a type 1 medical device (non measuring) so no notifying body to audit. I am unsure on a small point of my declaration of conformity. My issue is on the declaration I have the usual layout but I am unsure what MDD to refer to. On most of our older tech files (pre March 2010) it is 93/42/ECC but there is the 2007/47/EC which has amended 93/42/ECC.

What directive should I put on the declaration? In my draft I have " Compliance with directives 93/42/ECC as amended by 2007/47/EC" in guidelines it says that it is automatically deemed to refer to the revised version so it would be just 93/42/ECC?

A long post for a basic question ! Any help would be appreciated.

Thanks

Rus
 

pkost

Trusted Information Resource
Re: Conformity of declaration ... 2007/47/EC

Although I am not legally trained, my understanding is that 2007/47/EC amends 93/42/EC and therefore you can just say that you conform to 93/42/EC and if it is signed after the amendment it is assumed that you comply with 2007. We manufacture class IIa,b, and III and I have spoken to our notified body, they are happy for us to do this.

That being said, we own label one product and the original manufacturer kicked up a stink that we didn't refer to it as 93/42/EEC as amended by 2007/47/EC

If you are really pedantic, I believe you should refer to the statutory instrument (Statutory Instrument 2002 No. 618: The Medical Device Regulations 2002) in the UK as 93/42/EEC is merely a direction to the member states and not the manufacturers, but I'm sure someone can clarify that.

I think the general consensus is that it is not too important ;)
 
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Russbigbelly

Re: Conformity of declaration ... 2007/47/EC

Thanks... I could spend a long time being very pedantic.

Thanks for your input.
 

somashekar

Leader
Admin
Re: Conformity of declaration ... 2007/47/EC

Thanks... I could spend a long time being very pedantic.

Thanks for your input.
Manufacturers are required to declare the conformity of their product with the applicable directive in form of a Declaration of Conformity (irrespective of the class of the device and the fact if a Notified Body is involved in the conformity assessment or not). If manufacturers place products on the market or put them into service which comply with the new requirements prior to 21 March 2010, they should document that their Declaration of Conformity states compliance with Directives 90/385/EEC or 93/42/EEC, respectively, as amended by Directive 2007/47/EC. If the involvement of a Notified Body in the conformity evaluation is required, the responsible Notified Body must have checked compliance with the new legislation.
Declarations of Conformity issued as of 21 March 2010 are automatically deemed to refer to the relevant directive in its revised version. As of that date the manufacturers must be in a position to provide prove of compliance with all requirements of the revised directives which are applicable to their respective product.


The above is the clear way about DOC from below INTERPRETATIVE DOCUMENT. So it is now the 93/42/EEC. Hope it clarifies.

INTERPRETATIVE DOCUMENT OF THE COMMISSION'S SERVICES.
IMPLEMENTATION OF DIRECTIVE 2007/47/EC AMENDING
DIRECTIVES 90/385/EEC, 93/42/EEC AND 98/8/EC

For more details read THIS.
 
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pkost

Trusted Information Resource
Re: Conformity of declaration ... 2007/47/EC

I've never seen that document ... thanks
 

renenatasha

Involved In Discussions
Re: Declaration of Conformity - MDD (Medical Device Directive) 2007/47/EC or 93/42/EC

Welcome, Russ!

This is how we write part of our declaration concerning the amended version.

We herewith declare that the above mentioned product meets the provisions of the Council Directive 93/42/EEC for medical devices as amended by 2007/47/EC.

BTW, is anyone aware of the proposal to amend the directive? Check this out:
http://ec.europa.eu/health/medical-devices/documents/revision/
 
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aeropel

Re: Declaration of Conformity - MDD (Medical Device Directive) 2007/47/EC or 93/42/EC

It has been mentioned to me that I need to add the GMDN code for my medical device.
The device is a class IIa medical device. Do I need this code? It seems that there is a cost involved in getting this code.
Any ideas?

Thanks.
 

pkost

Trusted Information Resource
Re: Declaration of Conformity - MDD (Medical Device Directive) 2007/47/EC or 93/42/EC

There is no requirement to have a GMDN code on the DoC. Some countries may require GMDN or a local alternative, to register the product in their country (Italy springs to mind)

edit: I have a vague recollection about something different with GMDN and IVD's someone else might be able to clarify in this case if that is what you need
 
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aeropel

Re: Declaration of Conformity - MDD (Medical Device Directive) 2007/47/EC or 93/42/EC

Thanks. Ialso could not find a specific requirement for this code.
 

CharlieUK

Quite Involved in Discussions
Re: Declaration of Conformity - MDD (Medical Device Directive) 2007/47/EC or 93/42/EC

The Declaration should be against Directive 93/42/EEC - that is (still) the current Medical Device Directive#
List of Harmonised Standards, http://ec.europa.eu/enterprise/poli...onised-standards/medical-devices/index_en.htm, summarises it, and for comparison look at, say, EMC and LV where the older directives were Replaced by newer ones, and not just modified.

Also, declaration is always against Directive, not against any particular National Implementation (such as UK SI)

Charlie
 
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