CE Mark Part 1, Selecting A Notified Body
Canada, CE Mark, EU, Notified Body, Technical File
In order for a Medical Device to be sold in the EU, the device needs a CE Mark. In order to get a CE Mark for a Medical Device, the company needs a Notified Body to review the Technical File in accordance with the European Medical Device Directive. I get often asked, “can you recommend a Notified Body” or “what do you think of <Notified Body> xyz?”. I prefer to not answer these questions directly because a) my experience with any given Notified Body is limited and b) the staff and organization at Notified Bodies can change in ways that would make my answers either inaccurate or irrelevant. So rather than answer these questions directly, I recommend (and here’s the tip):
Select a Notified Body that fits your strategic and practical business objectives.
To help with this, I recommend asking a series of key questions to determine whether a candidate Notified Body fits with your business. Here are a few key questions:
- Where are the NB’s offices?
- Are they a CMDCAS QMS Registrar?
- Do you plan to ever sell in Canada?
- What language do they speak at the Headquarters?
- Do they also have a Test House?
- If so, do they provide the CB Full Certification Scheme (CB-FCS)?
- Does the Notified Body accept test reports from other Certified Test Houses?
- Do they handle non-Medical Devices?
For a more detailed description of how these questions can help you evaluate a potential Notified Body.
More Details
The location of the NB’s offices can help you evaluate:
- Is there a local office near your company?
- Is their Headquarters a place you might want to visit?
- Do you plan to sell in the Country where their Headquarters is located?
If you plan to sell in Canada, you will need a QMS Registrar that is on the list of approved QMS Registrars under the Canadian Medical Device Conformity Assessment System (CMDCAS), or has a cross-licensing agreement with a Registrar who is.
The language spoken at the Headquarters can sometimes be a barrier to communication. Or if you plan to sell in the country where the Headquarters is located, the language spoken at the Headquarters can sometimes be an advantage to communication.
Test House
If a Notified Body has a Test House, this can limit or expand your options for Standards Compliance testing, depending on several factors.
If you plan to sell worldwide, you may likely want to utilize the CB Full Certification Scheme (CB-FCS). If the Notified Body also has a Test House:
- If their Test House is not Certified to provide testing under the CB Scheme, you’ll need to find a different Test House from the Notified Body’s.
- If their Test House IS Certified to provide testing under the CB Scheme, it may be sticky to use a different Test House from the Notified Body’s.
Theoretically, the Notified Body is completely separate from their Test House. However, some Notified Bodies do not accept test reports from other Certified Test Houses. This can be costly and time-consuming.
Many “Test Houses” now do Conformity Assessment for Standards that are not “test” Standards (such as EN ISO 14971). This can potentially result in conflicts between how the Notified Body evaluates these “non-test” Standards.
Many devices that are classified as Medical Devices in one country (such as the US) are not Medical Devices in the EU. If the Notified Body does not handle non-Medical Devices, either these non-Medical Devices may be subjected to Medical Device requirements, so may not be able to get a CE Mark from that Notified Body. Since a company can only have one Notified Body, well I think you can see the dilemma.