Why a NB change from Annex II of MDD 93/42/EEC to Annex V?

[SteveK]

We have a full quality system for our class IIa and IIb devices and as such our CE certification indicates compliance with Annex II of MDD 93/42/EEC. A while back; based on very similar products on the market, I realised that one of our IIa products should really be a class I device with a measuring function (Im). I notified our NB about this re-classification with the appropriate background/evidence for this change. Eventually (two years later!) they indicated that this product would require a separate certificate under Annex V (production quality system). If we have what seems to be a ‘higher’ level QMS why would this be necessary?

Steve

 

[RobertvanBoxtel]

Re: Why a NB change from Annex II to Annex V?

Class I devices which are sterile or have a measuring function can be CE certified under Annex II. There is no need to change to Annex V only for those products.

 

[Chrisx]

Back before the last recast of the MDD, class Im devices were not eligible for Annex II, but this was changed. Something to keep in mind, Annex II requires design controls, so you need to have the appropriate design documentation for this conformity assessment route. This is not the case for Annex V.

 

[SteveK]

The organisation and content of my technical files regardless of class is the same – i.e. design documentation is in place for the Im device. I have raised the point with our NB but as yet I have received no feedback. It could be related to Annex V based certificates they have issued to other companies for similar products and consistency of format – since they appear to be having what I can only describe as ‘issues’ with their CB.

Steve