Brexit and Medical Devices
UK RESPONSIBLE PERSON = IMPORTER
What we already evaluated was strongly confirmed by a representative of the UK MHRA.
And more importantly it was stated that no independent UK RP is possible.
Please see the latest UK law here to verify this for yourself. In order to come to that conclusion, someone should not only read the requirements for the UK RP (schedule 77). In particular, the definitions for importer, UK RP and the definition for placing products on the market are needed. Then by nature the importer is placing products from a third country on the UK market, and in Schedule 95 states: “… the person placing products on the market is to be regarded as the UK responsible person…”
It was indeed intended that the importer is the UK RP, without leaving the possibility for an independent service provider to take over this role.
This will not only change the regulatory landscape significantly, but more importantly, the overall business approach to selling products in the UK needs to be thoroughly reviewed.
For example, the importer (your distributor, your precious customer) is now the UK RP and shall act on your behalf, with you being the manufacturer. However, the interest of a distributor may NOT coincide with the interest of the manufacturer. It starts already with the pricing, and how often was it necessary to change the distributor because you were not happy with their performance or demands?
It was clearly indicated that the manufacturer should act in order to prepare for this Brexit situation, but it was confirmed that the time line for implementing will be granted (4, 8 and 12 month).
A more thorough evaluation will follow shortly, and there is only one really safe solution to secure the business. However, these are not only regulatory decisions any longer. This is now an overall business aspect. This means other departments of the company must be informed and should participate in the discussion – NOW.
Please contact MDSS for further details and the possible solution on this scenario. Our office in the UK could support your solution.
- Brexit without a deal on October 31, 2019.
- Further extension for a few weeks or until January 2020 and then Brexit without a deal.
- Further extension with a deal. Transition until December 31, 2020 and then:
a. No agreement with the EU
b. Agreement with the EU and then:
i. Existing law as referenced above (only trade agreement but no Mutual recognition agreement (MRA) of approvals)
ii.New law and MRA.
And certainly, anything else may as well be possible.