Although there is less than 3 months to go until the Brexit date, conditions have not yet been agreed upon and it is likely that a no-deal will be reached.
MHRA notice on No-Deal Brexit
The current no-deal Brexit notice from the UK government states that businesses retailing devices in the UK require a ‘UK Responsible Person’ to be actually situated in the UK and not just have an address there if the business is not based there.
The government’s notice explains that if there is a no-deal outcome manufacturers outside the UK will have to have a ‘UK Responsible Person ‘ located in the UK. The function of this person would be akin to those of the European Authorized Representative under the EU medical device legislation.
The UK Medicines and Healthcare products Regulatory Agency (MHRA), which published the guidance note, says that where a device manufacturer is not based in the UK, the registration of a product with the MHRA must be taken on by a ‘UK Responsible Person’ recognized in the UK and having a UK registered address who will be accountable for the product in the UK. This person has to be in attendance at the address and has to provide particular information for the MHRA if requested, for example, declarations of conformity and technical documentation.
The European Commission on the other hand stipulated in an earlier notice to stakeholders that if there was a no-deal Brexit situation, companies with an authorized representative based in the UK would have to find a new Authorized Representative in an EU country if they want a representative to perform tasks on their behalf in the EU.
mdi Europa is aware that the situation is confusing. Should you require further details, please don’t hesitate to get in touch.
Sources: Medtech Insight (an Informa product), MHRA