Regulatory Open Forum

If you have ever changed the notified body you used for ISO 13485 or CE certification, I'd be interested to hear about your experience, including why you switched, for what type of certification, whether the process went smoothly or not so smoothly, and whether the end result was what you were hoping for when you decided to make the switch.

Thanks in advance,

Thanks, David.  Do you know what kinds of conformity their NB was assessing/certifying?  ISO 13485?  MDD?

If you have ever changed the notified body you used for ISO 13485 or CE certification, I'd be interested to hear about your experience, including why you switched, for what type of certification, whether the process went smoothly or not so smoothly, and whether the end result was what you were hoping for when you decided to make the switch.

Thanks in advance,

Many years ago (just before the required implementation of the IVD Directive - which tells you how long ago) the company I worked for changed from one registrar/Notified Body to another.  We did have at the time a single product that was governed by the MDD and required NB approval.  We did this because we felt that the registrar we were at the time using was excessively focused on compliance.  We wanted compliance, but we also wanted more: attention to the business benefits of a quality system.  I was the person leading the effort. 

We treated the process as for any significant decision.  We determined the "Musts" and the "Wants" for the new registrar/NB.  We did phone interviews of the candidates.  We got references and called the references.  We assessed the results and then conducted interviews in person with the top candidates to make the final decision.   We were basically happy with the outcome.  We had a new registrar/NB who not only addressed compliance but provided attention to the business benefits. 

An item that required particular attention was the timing of the labeling for the MDD product with the NB number on it.  I am sure this will be a particular concern for companies making this move nowadays.  It was our motivation in making the move prior to the implementation of the IVDD.

I seem to recall from reading an early draft of the new European medical device regulations that upon implementation of those regulations, a three party contract will be expected for such changes.  I am not sure this requirement made it into the final texts, but it makes a lot of sense.

If a client is making this kind of change, they will want to give a lot of attention to the details.

Bill

If you have ever changed the notified body you used for ISO 13485 or CE certification, I'd be interested to hear about your experience, including why you switched, for what type of certification, whether the process went smoothly or not so smoothly, and whether the end result was what you were hoping for when you decided to make the switch.

Thanks in advance,

If you have ever changed the notified body you used for ISO 13485 or CE certification, I'd be interested to hear about your experience, including why you switched, for what type of certification, whether the process went smoothly or not so smoothly, and whether the end result was what you were hoping for when you decided to make the switch.

Thanks in advance,