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Brexit Statement from Bee Robotics

01/02/2019

Bee Robotics Ltd

Unit 32-33, Cibyn Ind. Estate

Caernarfon, Gwynedd LL55 2BD

Tel: + 44 (0)1286 672744

Fax: + 44 (0)1286 678322

Brexit Statement from Bee Robotics

 

Dear Colleagues

During this difficult time of uncertainty, we would like to reassure our Distributors that Bee has taken measures to understand as best as possible any impact Brexit may have on our business relationship and will continue to monitor the situation as developments transpire.

We sell our IVD instruments extensively into the EU either under our brand name or under an OEM agreement.

Under the existing IVD Directive, our instruments are classed as low risk, therefore, do not need a Notified Body (i.e. self-declaration) therefore the “CE” mark will still be valid (and also the instrument it’s self hasn’t changed).

Since we are able to self-certify our products for CE marking our CE Declaration of Conformity will still be valid for all our instruments and should the UK and the EU decide on a “no deal” it will be necessary for Bee to appoint an EU representative in order to register our products in the EU (it is likely that our EU representative will be based in Ireland and have already identified a representative should this become necessary).

Under our OEM agreements the Distributors are the legal manufacturers of the products and in accordance with the current IVDD regulations clients who purchase our products under our brand name are still classed as our Distributors until the IVDR regulations become applicable (due to come into force in May 2022) where they will then be classed as importers (with additional responsibilities).

Bee have also spoken to several of its suppliers who have in turn taken some steps to minimise any potential disruption and as far as we know to date we have not come across difficulties in sourcing components for our manufacturing process but will continue to monitor the situation very closely.

In the meantime should you have any specific concerns or questions please feel free to contact myself or Andrew Bradley our Quality and Regulatory Affairs Manager (andrew.bradley@beerobotics.com)

We hope that the final outcome of the Brexit negotiation will allow us to continue our valued business collaboration without too much disruption and we thank you for your support during these unchartered times.

Yours Sincerely

Steve Jones

Managing Director

 


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