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CE Marking Requirements MDD & MDR - new product development covered under same scope

#1
Hi
We are developing a new product, that will be covered under our existing CE Scope (the product is the same Classification - Class IIb), will our Product Technical File require a review by the Notified Body.
Also, our current CE is only just recently under MDD (Annex II w/o 4), however, will we need to apply MDR to this new product.

I've been getting conflicting information on various websites, so not entirely sure.
Thank you in advance.
 

Ronen E

Problem Solver
Staff member
Moderator
#2
I've been getting conflicting information on various websites, so not entirely sure.
If your strategy is asking around online, how can you ever be sure?... Why place more (or any) importance on what we'd say here?...
The only authority on this should be your NB. You are an existing customer, so they *should* respond ("should" because if you are a small customer, currently only with an MDD scope (not MDR), they probbly have higher priorities).
will our Product Technical File require a review by the Notified Body.
Definitely; the only question is whether it should happen before placing the new device on the market, or as part of the next audit. Being a class IIb device and with the next audit not anytime soon (?), I'd say you need to be proactive and approach your NB, telling them you have a new device in the pipeline, and proceed according to their instructions.
Also, our current CE is only just recently under MDD (Annex II w/o 4), however, will we need to apply MDR to this new product.
I'll take a guess that regardless of how agile you and your NB are, it's likely to be too late for MDD certification; hence it'll probably be handled under the MDR (is your NB MDR designated?).
 
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