Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hi, all!

 

Would a notified body like BSI would be willing to issue a certificate under IVDD for our devices that don't fall in a risk category that would require NB (self-certified devices)?  I'm wondering whether we could get the 2-year extension described in IVDR Article 110 ("Transitional Provisions") by getting NB certificates even if we aren't required to do so under IVDD.  Any direction on this matter would be appreciated.  Thanks!

Hello Anon,

I can see where you are going with this thought process, with the way Conformity Assessment is set up, most likely not.  There are also legal implications for Notified Bodies to issue CE Certificates which not being a solicitor could not comment on, but from experience tried to do this before unsuccessfully.  You would have to prove why your IVDD device is a higher classification requiring conformity assessment through List A or List B, because otherwise all other products are on the General List.  You can not just ask for a CE Certificate because you want one, the device classification has to be supported through the Articles and conformity assessment routes.  You could try and ask for one, but have asked for CE Certificates on Class I medical devices unsucccessfully.

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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 14-Sep-2020 13:00
From: Anonymous Member
Subject: NB-issued IVDD certificate for Class II devices

This message was posted by a user wishing to remain anonymous

Hi, all!

 

Would a notified body like BSI would be willing to issue a certificate under IVDD for our devices that don't fall in a risk category that would require NB (self-certified devices)?  I'm wondering whether we could get the 2-year extension described in IVDR Article 110 ("Transitional Provisions") by getting NB certificates even if we aren't required to do so under IVDD.  Any direction on this matter would be appreciated.  Thanks!

Hi
In a past life I was Head of IVD for BSI so I hope this will help.  NBs can only issue certificates within the scope they are designated to on the NANDO website https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=20
As a result they could not issue a certificate for TSH assay for example. This is the real issue with the IVDR over 80% of devices have a hard stop of 26 May 2022.  Industry is pushing hard for an extension or a modified approach for different classes of devices; however, as discussed at the Convergence opening panel some Competent Authorities are concerned because SARS-CoV-2 assays are self declared under the IVDD and they would like to see the new regulations in operation.   
So don't bank on an extension it is still in the lap of the Gods and even if there is one it may not apply to your products!

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Sue Spencer
IVD Lead/ Principal Consultant
London
United Kingdom
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Original Message:
Sent: 14-Sep-2020 13:00
From: Anonymous Member
Subject: NB-issued IVDD certificate for Class II devices

This message was posted by a user wishing to remain anonymous

Hi, all!

 

Would a notified body like BSI would be willing to issue a certificate under IVDD for our devices that don't fall in a risk category that would require NB (self-certified devices)?  I'm wondering whether we could get the 2-year extension described in IVDR Article 110 ("Transitional Provisions") by getting NB certificates even if we aren't required to do so under IVDD.  Any direction on this matter would be appreciated.  Thanks!