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Hi Risk management may have been around for years but is a real weak spot for IVD manufacturers and gives rise to NB questions under the IVDR. Many do not consider harm to the patient at all but stop at false positive or negative and do not consider what impact this could have on the patient. The guidance ...

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 ...

Hi I'm guessing that this is an instrument.  If so consider the expectations for fully refurbished.  You can replace parts like for like, even if they are not identical; however, if you upgrade or add a new feature/ intended purpose you will be caught.  The IVDR does not apply to secondhand instruments. ...

When looking at a file you want to know what components are included and what is required but sold separately. For example; a manual kit with separate bottles of solid phase, conjugate, standards and controls these are all components.  If a wash buffer is required but sold separately you would want ...

Brilliant Heather thanks this will be really useful! ------------------------------ Sue Spencer IVD Lead/ Principal Consultant London United Kingdom ------------------------------