The UK never ending story comes to an end!
We published a Brexit News & Views beginning of October for our clients to react, if needed, should a hard Brexit occur, which was on the horizon at that time.
Since then the core message has not changed. The importer in the UK is the UK responsible person (UK RP) by definition. Given the current draft regulation it is NOT foreseen to appoint an independent UK RP. As it seems the MHRA is aware of this difficult situation and communicated with some industry associations that they were indeed not very happy about it. Their guidance still has a few inconsistencies and does not necessarily reflect the proposed law. Also, the law has some inconsistencies and in some instances does not make sense.
What has changed since our last News & Views regarding Brexit:
The UK will leave on January 31, 2020 the EU and this will be done in a somewhat orderly manner (!?) with a withdrawal agreement.
Our current understanding of orderly means a transition period is in place until December 31, 2020. This transition means that all EU rules and regulations will continue to apply, but the UK will be allowed to install their own laws. The Medical Device law is expected to be implemented in due time (March?!).
The timeline outlined in the above News & Views, which are derived from MHRA guidance may no longer apply.
The UK and the EU are supposed to reach a trade agreement by December 31, 2020.
However, that is very unlikely and a delayed hard Brexit may still be possible.
In June, the UK may ask for an extension of this transition beyond 2020 to complete the trade negotiation. However, the UK has already determined not to seek an extension.
The proposal for an agreement must be in place by November to get it presented to the European Parliament in order to be ratified by the end of December.
Having stated the above, what needs to be done:
It is important to review and maybe adjust the UK distribution. Anyone who receives your product in the UK, whether directly from a manufacturer or from any of the remaining EU countries is the importer and can only import if he also takes on the requirements of the UK RP. There are a number of consequences:
- It may be needed to organize the UK distribution differently. For instance, it may be beneficial to have only one single distributor, who is the importer/UK RP, you can rely on.
- A solid agreement must support that role (required anyway for the importer).
- MDSS may be installed for record keeping etc. However, this can only be done if the importer/UK RP allows it. A three way agreement should be in place.
From our UK clients we hear that the MHRA is trying to give advice to the lawmaker to change the proposed law in order to allow for an independent UK RP. However, we have checked and there is no update - yet.
It is currently difficult to recommend a clear solution for the UK RP since the law is not finalized. Any agreement we would sign today most likely will have to be adjusted. Should there be the possibility of an independent UK RP then in that case a contract with MDSS is ready except for the any last minute changes.
In any case should December 31, 2020 become the deadline – again for a hard Brexit, then we recommend to stock products in the UK since in such an instance, trade will be significantly disrupted for a few months due the implementation of customs and border control.
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UK Responsible Person6 Wilmslow Road, Rusholme, Manchester M14 5TP, UK
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Comments (1)
Please clarify - if the EC Rep under MDD is based in UK, can the Rep continue in the same way until Dec 31, 2020 (notwithstanding the changes required by MDR)?
Dear Jonathan,
Thank you for the question.
From the EU Commission website:
“During the Transition Period, the United Kingdom is no longer a Member State of the European Union or of the European Atomic Energy Community. As a third country, it will no longer participate in the EU’s decision-making processes.”
However, “All EU law, across all policy areas, is still applicable to, and in, the United Kingdom(…)”
Therefore, it is our understanding that the EC REP in the UK is still a valid EC REP for now. An EC REP located in the UK according to the MDR should be possible as well until December 31.
Ludger