CE Certificate Expiring and NB unable to extend / renew as not in their scope as a NB

[AlanPG]

We are a small company that holds an OBL Medical Device EC Certificate for some class IIa and IIb devices. Our certificate is due to expire shortly and we have been trying to renew / extend it. Unfortunately our NB (AMTAC / Intertek) has been ignoring our correspondence since April.

We then recently wrote to the MHRA who contacted our NB and all of a sudden the NB emailed to say that they could not issue a new certificate as this was no longer within their scope of designation as a NB but " We are working closely with MHRA to determine the way forward for the transition."

Has anyone had experience of this? We are now stuck trying to migrate to a new NB with only a few weeks before our current certificate expires.

Many thanks

Alan

 

[RobertvanBoxtel]

Re: CE Certificate Expiring and NB unable to extend / renew as not in their scope as

Not sure on the specifics here with Amtac/intertek, but it is known that UK NB's are treating OBL constructions very black and white, meaning: OBL is not a term under the MDD and we will treat you as a regular manufacturer. This will require you to have all technical documentation on the product available. Any formerly issued certificates that identify wording along the way of "under OBL construction" will not be re-issued anymore.

Sorry, I realize my answer does not help you in your situation, you will have to move anyway if they are not responding.

 

[SteveK]

Re: CE Certificate Expiring and NB unable to extend / renew as not in their scope as

I wonder if this relates to the new Medical Device Regulations i.e. the reference to “the transition”. These have not been officially published, but will now require an OBL company to have full Technical Files (as Robert indicated), which I suspect you do not have (not a requirement for an OBL currently). Even when official published in the EU journal (2017?) there will be a three year transition period, so under the current MDD93/42/EEC you should still comply with the requirements for having a new certificate issued (assuming your last audit was OK). This does therefore seem very odd - though Roberts' insight about UK NBs is not something I am aware of. I would suggest you get back to the MHRA as I think your NB is not meeting its current obligations to you as a company.

Steve

 

[RobertvanBoxtel]

Re: CE Certificate Expiring and NB unable to extend / renew as not in their scope as

Most likely indeed there is a link to what is being negotiated in the MDR at the moment, CA's already imposing it on their NB's. The MHRA intended to write a guidance document on OBL and got "corrected" by the European Commission on this. As a result, they moved to the other extreme, strictly enforcing the Commission Recommendation 2013_473_EU on how NB should assess compliance.
And they follow it strictly resulting in no more OBL constructions.

 

[AlanPG]

Re: CE Certificate Expiring and NB unable to extend / renew as not in their scope as

Thank you Robert and Steve for your messages.

The MHRA have informed us that our NB should get back to me this week with further details.

Are all NBs not extending these types of OBL certificates?

Should they have not given us reasonable notice of this?

Many thanks

Alan

 

[AlanPG]

Re: CE Certificate Expiring and NB unable to extend / renew as not in their scope as

Further to my last post, I have just reviewed our last audit and it appears to be following 2013/473/EU recommendations including technical file review and unannounced audits of our subcontractors etc. It was following this audit that we had to make some changes in our QMS to allow for these recommendations eg amending our agreement with our subcontractor to allow for unannounced audits and providing further manufacturing details in our technical file.

It appears to me that there is more to this and it relates specifically to our NB rather than the NBs in general.

Many thanks in advance.

 

[SteveK]

Re: CE Certificate Expiring and NB unable to extend / renew as not in their scope as

If you haven't already seen this you might find this recent article of interest:

https://embed.topra.org/sites/defau...regulatory-rapporteur_own-brand-labelling.pdf

Also although the MHRA did not publish its OBL Guidance, the draft is available here (again if not already seen):

http://www.medilinkem.com/docs/defa...-april-2016-(new-format)---draft.pdf?sfvrsn=2

Steve

 

[Ronen E]

Re: CE Certificate Expiring and NB unable to extend / renew as not in their scope as

You can check to see if your devices are still within their notification scope (scroll down to p. 2):

http://ec.europa.eu/growth/tools-da...tion=notification.pdf&dir_id=13&ntf_id=260028

 

[AlanPG]

Re: CE Certificate Expiring and NB unable to extend / renew as not in their scope as

Thank you Steve and Ronen.

What is strange is that the devices are still listed within their scope. But the MHRA wrote to us yesterday with regards to AMTAC and said:

Dear Alan,

You should hear from them this week. All will be clear once they contact you.

You may deal with a new Notified Body to progress on that front but also await feedback from your existing notified body regarding your certificate.

Kind regards

So we will have to wait and see.

 

[SteveK]

Re: CE Certificate Expiring and NB unable to extend / renew as not in their scope as

Hi Alan,

As pointed out in another forum last year, the European Commission reported that not everything in NANDO is up to date as it should be. If you have not done so already, check out NBOG Best Practices Guide 2006-1 on changing NBs.

http://www.nbog.eu/resources/NBOG_BPG_2006_1.pdf

Regardless, I hope things work out for you.

Steve