Is using Annex V of 93/42/EEC for CE Certification incorrect for a Class IIb Device?

[SteveK]

Hi All,

This question has come up after reviewing a competitor CE Certificate.

They have used the Annex V Section 3.2 route (Production Quality Assurance), where as ours is the Full Quality Assurance System (Annex II). Common devices in our ranges are medical gas regulators which we have classified using rule 11 (Annex IX). As such these are classified as Class IIb devices, not IIa because of their hazardous nature (see MEDDEV 2.4/1 rev8). Our CE marking route applies to both Class IIa & IIb – so we are correctly covered (Annex II, Section 7). However, our competitor’s route only applies to Class IIa (Annex V, Section 6).

Am I right in thinking that therefore they have followed an incorrect route for their overall CE certification (and their NB also) or have I misunderstood something in the MDD (note: I have not been able to find out what classification they actually use IIa or IIb i.e. for a DoC)?

Steve

[Persson - 2010]

In Reply to Parent Post by SteveK

Hi All,

This question has come up after reviewing a competitor CE Certificate.

They have used the Annex V Section 3.2 route (Production Quality Assurance), where as ours is the Full Quality Assurance System (Annex II). Common devices in our ranges are medical gas regulators which we have classified using rule 11 (Annex IX). As such these are classified as Class IIb devices, not IIa because of their hazardous nature (see MEDDEV 2.4/1 rev8). Our CE marking route applies to both Class IIa & IIb – so we are correctly covered (Annex II, Section 7). However, our competitor’s route only applies to Class IIa (Annex V, Section 6).

Am I right in thinking that therefore they have followed an incorrect route for their overall CE certification (and their NB also) or have I misunderstood something in the MDD (note: I have not been able to find out what classification they actually use IIa or IIb i.e. for a DoC)?

Steve

Every road leads to Rome!
Several routes lead to CE-marking!

For Class IIa:
"Annex VII + Annex V" can certainly be used as one of the correct Conformity Assessment Routes; Please refer below for futher info.
http://www.ce-marking.com/medical-de...class-IIa.html

For Class IIb:
"Annex III + Annex V" can also be used as one of the Conformity Assessment Routes; Please refer below for futher info.
http://www.ce-marking.com/medical-de...class-IIb.html

[SteveK]

Hi Persson,

Thanks for the links - very useful reference material to have on file. So for class IIb as you indicate it needs to be both Annex III and V. Therefore if the certification (CE certificate) does not indicate compliance to Annex III as well, then it is incorrect/non-compliant with respect to representing a class IIb device. Is this a correct interpretation?

Steve

[LievenDW]

Yes, that is right. For Class IIb it is either Annex II (excl. clause 4) or Annex III together with Annex IV, Annex V or Annex VI.

[Marcelo Antunes]

Not saying that anyone is right or wrong...i would take care with certificates...i´ve seen problems in certificates issued by different NBs, in which the problem was in the way the certificate itself was written, not that the manufacturer was non-compliant.

[Rob Udo]

Indeed several routes lead to CE mark. Be aware that it does impact the freedom that you have as manufacturer.

An Annex V + ... means in most cases less freedom. All (substantial) changes needs Notified Body approval before they can be implemented.

If you have an Annex II route you have more freedom to modify your products and you may act as an internal 'notified body'. Sure the Notified Body will review it during their next assessment, but you need less approvals before you can introduce the modified product in the market.

Rob.

[Persson - 2010]

In Reply to Parent Post by SteveK

Hi Persson,

Thanks for the links - very useful reference material to have on file. So for class IIb as you indicate it needs to be both Annex III and V. Therefore if the certification (CE certificate) does not indicate compliance to Annex III as well, then it is incorrect/non-compliant with respect to representing a class IIb device. Is this a correct interpretation?

Steve

For Class IIb, the manufacturer will need
both
Product Certification (i.e. an EC Type Examination Certificate per Annex III)
and
Quality System Assessment (i.e. an EC Production Quality Assurance Certificate per Annex V).

[arios]

The following text was taken from the M5 version of the MDD 93/42/EEC, Article 11 :

3. In the case of devices falling within Class IIb, other than devices
which are custom-made or intended for clinical investigations, the
manufacturer shall, in order to affix the CE marking, either:
(a) follow the procedure relating to the EC declaration of conformity
set out in Annex II (full quality assurance); in this case, point 4 of
Annex II is not applicable; or
(b) follow the procedure relating to the EC type-examination set out in
Annex III, coupled with:
(i) the procedure relating to the EC verification set out in Annex
IV;
or
(ii) the procedure relating to the EC declaration of conformity set
out in Annex V (production quality assurance);
or
(iii) the procedure relating to the EC declaration of conformity set
out in Annex VI (product quality assurance).

As you can see it includes the different conformity assessment routes.