With the previous News & Views, we highlighted that the proposed Brexit regulation mandated a UK RP, which by definition would be the importer. The latest news is that this is now obsolete!
A UK RP will be required and may be independent of the Importer.
We would like to conduct a survey; which manufacturers would need a UK RP. Due to the staggered registration transition, we ask for further information.
In general, trade with the UK will be different when the UK leaves the EU Single Market for good in about 11 weeks (December 31, 2020).
The EU and the UK government are preparing for this and are building border controls. The UK must also ensure the supply of goods, in particular medicines and medical devices. It is expected that trade in general will be disrupted for quite some time, and therefore it may make sense to deliver products to the UK now – if possible. Only for a few weeks/months, to bypass the initial difficulties.
The consequences for medical devices are even more significant, since those will be regulated differently in the future. Here is the link to the guidance as provided by the UK MHRA.
A few main points:
- Medical Devices may be marketed with the CE mark for the time being, as the current law is based on the directive. This regulation will be updated.
- A UKCA Mark may immediately be applied and will be required by 2023. A UK conformity assessment body will need to be involved with a required conformity assessment.
- A UK RP will be required most likely on day one. Therefore, a contract with an UK RP must be in place by January 1, 2021 or at the latest with your next shipment in 2021.
- The registration will have to be performed by the UK RP on behalf of the manufacturer within 4, 8 and 12 months. The timeline is based on the risk class.
- The labeling will need to be updated in due time to show the UKCA Mark and the UK RP, most likely at the latest by 2023.