New IVD Registration Update Under MHRA

Under a new guidance document the EU provided new guidance for the EU IVDR transition extension under Article 110. This guidance specifically changes the registration of IVD devices with the MHRA. Additionally, there were minor updates for medical device registration, specifically for devices captured under the EU MDR transition extension under Article 120.

Additional Updates on IVD Registration

Additional key updates include:

• • New MHRA IVD registration update that includes expired or expiring CE certificates that remain valid under the EU IVDR.
  • Addresses the validity of certain EU IVDD CE certificates for specific IVD devices, allowing their placement on the markets of Northern Ireland and Great Britain for a limited time.
  • IVD devices that are up classified under the EU IVDR from General IVD to Class B, C, or D will now require Notified Body assessment.

 Learn more:

• • Regulating medical devices in the UK – GOV.UK
  • Registration of in vitro diagnostic devices with expiring CE certificates – GOV.UK
  • Registration of reusable or upclassified Class I devices and/or expiring CE certificates – GOV.UK

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• • EUDAMED Registration
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