A lot of clarification is needed, but an immediate requirement is the implementation of the UK Responsible Person. A legal entity is now being installed by MDSS for our clients, as indicated in the January News and Views: 1. Open up the legal entity within the next days 2. Establish local presence to ensure availability for the MHRA 3. Perform notification of products according to the MHRA plan * Highest risk class within 4 months * Medium risk class within 8 months * Low risk class within 12 months
The UK Responsible Person (UK RP) contract will be similar to the contract you already have with MDSS, but outlining the UK specifics. We recommend for all clients to place additional products on the UK market with your customers before March 29 to ensure sufficient supply for a few weeks! Please note UK entities working in the health care industry are being asked to store additional products since delays are anticipated in all areas due to a Brexit without a deal (Chaos Brexit). An example will be border control for all goods from the remaining 27 EU Member States, which will most certainly require resources to release your products.
Please inform your MDSS main contact in case you have business in the UK.
And contact us for our In-house workshop which will be tailored to your requirements!