Using MDD Annex III + V Conformity Assessment Pathway

Sam Lazzara

Trusted Information Resource
I have only used MDD Annex II (Full quality assurance system) to obtain CE marking.

Any experience with using Annex III (EC-Type Examination) combined with Annex V (Production quality assurance)?

Advantages? Disadvantages?

Any differences between thresholds for having to submit a Change Notice to the Notified Body when using Annex III as compared to Annex II?
 
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Ronen E

Problem Solver
Moderator
I have only used MDD Annex II (Full quality assurance system) to obtain CE marking.

Any experience with using Annex III (EC-Type Examination) combined with Annex V (Production quality assurance)?

Advantages? Disadvantages?

Any differences between thresholds for having to submit a Change Notice to the Notified Body when using Annex III as compared to Annex II?

Hi Sam,

I also never went through certification to annex III+V. My impression, based on discussions with peers, manufacturers and NB staff, is that annex III certification has the following (serious) downsides:

1. Initial certification might involve lengthy and expensive testing by the NB (or outsourced by the NB).

2. Every significant change of the device, post-certification, must be communicated with the NB, and might trigger another round of lengthy and costly examination and testing.

Regarding notification of "significant changes" of the QMS, I'm not aware of the threshold being different for annexes II and V.

Cheers,
Ronen.
 

RobertvanBoxtel

Involved In Discussions
Hi Sam,

Please refer to http://www.nbog.eu/resources/NBOG_BPG_2014_3.pdf for a comparison on notification requirements between Annex II and Annex III/V.

In case you are a start-up with only one device type, Class III, in practice there is no difference in the post CE phase regarding notification. To obtain CE marking, the Notified Body might require witness testing or perform it's own testing conform Annex III. Or they will review the documents of testing done, depending on the NB. As a start-up, it is sometimes difficult to cover all the requirements of Annex II and expectations of NB's related to Annex II. IF during the Design Dossier review many questions are to be answered that demonstrate that Annex II is not really understood and covered by the manufacturer, the NB can decide not to issue Annex II and Annex II.4 certificates, but allow the product on the market (after answering all questions adequately) under Annex III/V.

For the situation above, if your device is Class IIb, the initial assessment under Annex II will not be much different (again in practice), but once in the market, you have less prior approval requriements. Under Annex III/V those still exist as described above.

Greetings, Robert
 
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