Spanish Customs Claim: Has the MDD class to be mentioned in the DoC?

S

SUCRAM

#1
Hi all,

Just e quick and urgent question:

Our US provider does issue DoC for each order. It used to include all ordered articles in it, indepently of its device class. It only refers to the QS and 93/42/EEC w/o mentioning the notified body, product device class or the applicable Annex or Rule. Spanish health board inspector requests DoCs with this information included. Provider says that this is enough. I have attached an example of one of the affected DoC.
Could anyone give me advice?

Thanks in advance

Sucram
 

Attachments

Elsmar Forum Sponsor
S

SteveK

#2
I think there is a bit of a mix up here – I could be wrong, but the attached document is a “Certificate of Conformity”, not a DoC as defined by the MDD. My understanding is that a CoC is a document for confirming conformity between supplier and customer i.e. not for regulatory purposes. A DoC will have to have the information requested.:2cents:
 
S

SUCRAM

#3
Good point, SteveK. Thanks. I had included the wrong file. Please see the one in this post. The layout seems to by correct, but the content is incomplete acording customs. I thinks so, too. Greetings
 

Attachments

xcanals_tecno-med.es

Involved In Discussions
#4
Dear all

the SteveK answer is correct the annexed document is not a Declaration of Conformity with the directive 93/42/EEC

The Spanish Health Authorities asks for a DoC with the class of the medical devices because if the medical devices are not class I they need the certificate of a Notified Body

As you may know the new Royal Decree 1591/2009 which incorporates the directive 2007/47/EC to the Spanish legislation was changed and from 21 mars 2010 the products class IIa are also required to communicate to the AEMPS

Best regards

Xavier
 
S

SUCRAM

#5
Hi Xavier, please see my second post where I have included the respective DoC. In the first one I mistakenly put the wrong doc. Could u please revise the second one? Regarding the 1591/2009, yes I am aware of this. We had been informed by our consultant via email and are currently preparing the registering of our IIa articles we are distributing in Spain. Thanks
 
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xcanals_tecno-med.es

Involved In Discussions
#6
Hi Sucram

The reason of the claim is due to the type of products "electrodes for electrosurgery" which are sometimes not classified as class IIb and that is the issue which the AEMPS is looking for

See the guidance on borderline classification:
http://ec.europa.eu/enterprise/sect...ber_lists/version1_5_borderline_manual_en.pdf

which states:

8.8. Neutral electrodes for high frequency surgery
- Background
The issue relates to the classification of neutral electrodes which are accessories for High
Frequency (HF) surgery. In general there are two types of electrodes used in high frequency
surgery: those which are ‘active’ concentrate the energy and convert it into heat and those
which are ‘neutral’ and simply transfer the energy between two points.
The MEDDEV does not make this distinction and places both electrodes active and neutral
under rule 9, consequently they are both considered to be in Class IIb. This is the result from
discussions a few years ago, and that is why the MEDDEV puts both electrodes in the same
Class IIb. However, manufacturers do make this distinction.
- Outcome
Current guidance (MEDDEV 2.4/1 under rule 9) indicates that all such electrodes should be
considered as Class IIb products, irrespective of their nature (active or neutral) as they may be
potentially hazardous. It is concluded that the neutral electrodes are medical devices which
involve potentially hazardous exchange of energy and should be Class IIb medical devices.
 
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