CE Mark with same NB (Notified Body)?

[Dobby1979]

Morning All,

Does anyone know whether your CE Mark has to be with the same accreditation board as your ISO 13485 for example? For example, could I get ISO 13485 certification with LRQA but apply for CE Mark (when ready) through BSI?

 

[chris1price]

Yes, there is nothing to stop you using different bodies for ISO13485 and CE Marking.

However you may have additional inspections and extra costs.

Chris

 

[divyag]

Certainly, you can use different notified bodies for product certification, however the time and cost involved for the audit will double up. You may spend more time in facing the audit rather than working on product efficiently. Suggestion is to always consider having a single NB to smoothen up the process and work efficiently.

 

[Marcelo]

Just a reminder, as I always try and note: for CE Marking, you use a Notified Body, which is designated by a Competent (regulatory) Authority following CE Marking requirements, based on the conformity assessment "route" chosen.

QMS certification such as ISO 13485 are performed by Certification Bodies, which follows different rules.

A lot of bodies are both a certification body and a notified body, but notified bodies do not certify QMSs nor any other thing.

 

[Lorenzo]

As already mentioned, you are free to choose where you want to carry out the CE approval. I would also recommend that you commission a company for both procedures.
Many notified bodies have different opinions and views on numerous points.
What you get certified by one Notified Body can be rejected by another Notified Body. Therefore, always stick to one election.