Long awaited news from the #MHRA regarding #CE marking for Medical devices – previously it was communicated that there would be an indefinite recognition of CE marking. The update was lacking on clarity for which specific products this was relevant to.
However, (yesterday) on the 1st August, confirmation that this does NOT apply to Medical Devices or IVD’s
A quick refresher:
– Medical devices with a CE mark under the #MDD can be placed on the UK market until June 30th 2028 or until certification expires
– Medical devices with a CE mark under the #MDR can be placed on the UK market until June 30th 2030 or until the expiratory on the certificate
-IVD Medical Devices compliant with the EU IVD devices directive (EU IVDD) can be placed on the UK market June 30th 2030 or until the expiratory of the certificate
This is a refreshing and long awaited update for the clarity of the CE marking for those manufacturing devices. If you’d like to discuss CE marking and/or UKCA marking, please get in touch and our friendly team will respond.
