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Iso13485 certification vs CE technical audit

#1
We work on a class 1m device, We have implemented iso13485.

We would like to know Is it mandatory to get our system certified as a proof for demonstrating conformity or wait for the entire product lifecycle to be completed and go for design dossier file audit along with iso13485 ? Will we be audited again as a part of CE technical audit for which we have to spare the same cost again ?

Which would be a better strategy and what will be the implications ?
 
#2
Dear vishnums,

please clarify the question:
Is the quality management system (QMS) only implemented or is it already certified?
Where do you want to register the class 1m device?
What do you mean with "wait for the enitre product lifecycle to be completed"?

Kind regards
thinqbetter
 
#3
Is the quality management system (QMS) only implemented or is it already certified?
QMS is only implemented but not certified.
Where do you want to register the class 1m device?
In Europe
What do you mean with "wait for the enitre product lifecycle to be completed"?
We are in the process of completing our production process validation and do a pilot production.
 

Ronen E

Problem Solver
Staff member
Super Moderator
#4
We work on a class 1m device, We have implemented iso13485.

We would like to know Is it mandatory to get our system certified as a proof for demonstrating conformity or wait for the entire product lifecycle to be completed and go for design dossier file audit along with iso13485 ? Will we be audited again as a part of CE technical audit for which we have to spare the same cost again ?

Which would be a better strategy and what will be the implications ?
Is the quality management system (QMS) only implemented or is it already certified?
QMS is only implemented but not certified.
Where do you want to register the class 1m device?
In Europe
What do you mean with "wait for the enitre product lifecycle to be completed"?
We are in the process of completing our production process validation and do a pilot production.
Hi,

If you work at a (relatively) new company or on a new class 1m device which you'd like to introduce in Europe, you might be in trouble until at least the end of 2020. You'll need a Notified Body (NB) intervention and currently it seems that they're all overbooked (and overwhelmed) and not taking on new customers / projects.

Once you manage to engage with a NB they'll need to audit you on-site, addressing the measurement aspects (only) of your device. In that regard they will also audit your QMS - ISO 13485 certification is NOT mandatory for EU certification, but it's the most straightforward path for proving QMS complaince with the EU MDR, and NB's preferred path. So theoretically no, it's not mandatory, but practically pretty much...

For ISO 13485 certification you don't have to have "the whole product lifecycle completed" - you will be audited on having all the required QMS infrastructure in place (even parts you're not using yet - assuming they're going to become relevant in, say, the 12 months following certification), and on the implementation of the parts that are already set in motion. However, for getting your device EC certified by the NB (probably what you refer to as "CE technical audit" or "design dossier file audit"), its design and manufacturing setup must be complete to an extent. I would say you'd need to complete design validation and design transfer, and be already running commercial pilot production, at least. In the EU, you can't get certified for a "theoretical" device (like clearing a 510k in the USA regardless of production).

When you're ready (and a NB is available) you can have a single audit that covers the QMS and the device (the technical file) - again, for a class 1m device only the measurement function aspects will be audited; other than that it's a class 1 device and your compliance is self-certified for all OTHER aspects.

Cost-wise it's obviously better to do everything in one go (unless you're active in other markets as well where some value can be gained from a stand-alone ISO 13485 certification, while you're waiting for a NB to become available).

Good luck (you will need it),
Ronen.
 
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