Registration of legacy devices in the UK: The EU MDR transitional arrangements have been amended to extend the validity of EU MDD and EU AIMDD CE certificates, subject to meeting certain conditions. The validity has been extended to 31 December 2027 for higher risk devices (Class III and IIb implantable devices) and 31 December 2028 […]
We expect many developments within our field of expertise for 2023. These are the main developments of which we are certain that they will impact you. In this blogpost we will briefly explain what changes will occur, how this will impact you, and how we can help you handle them. You can expect more detailed […]
Last week’s blogpost discussed what an Authorised Representative (AR) does and what they can do for a manufacturer who is based outside of the EU. Because this was rather specific to EU context, this blogpost will look at the concept of an AR within UK context. For the UK market, the term AR is not […]
With Brexit officially being enforced from 1 January 2021, any product importers from the European Union were originally due to apply the UK Conformity Assessed (UKCA) Marking to all products by the end of 2021. The UK government announced on 24th August 2021 that businesses will have an additional year to apply new product safety markings for most products placed on the market in England, Scotland and Wales.