News & Views - March, 2019

2019.03.04

• Brexit: MDSS UK Subsidiary

Brexit: MDSS UK Subsidiary

Brexit – the never-ending story. The UK MHRA has published additional documents in case of a Brexit without a deal.

Here is the excerpt from the UK official site what is planned:

“How devices will be regulated from 29 March 2019
The EU AIMDD, EU MDD and EU IVDD will continue to apply to the UK through the UK MDR 2002.
The Medical Devices (Amendment etc.) (EU exit) Regulations 2019 (UK MDR 2019) will amend the UK MDR 2002 in part by fixing deficiencies in those Regulations to reflect the new regime for our departure from the EU.
The UK MDR 2019 will also transpose all the key elements contained in the EU MDR and EU IVDR, which will be brought into force in line with the transitional timetable being followed by the EU for the full application of those two Regulations.
These new requirements can be found in Part VIII of the UK MDR 2002 (for medical devices) and Part IX of the UK MDR 2002 (for IVDs).”

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!