Preparations for Leaving the EU – Advice note for EU-based customers
As the end of the transition period of the UK leaving the EU on 31 December 2020 is fast approaching, I wanted to update you on the preparations The Binding Site Group Limited and its global subsidiaries have continued to ensure we maintain the high levels of supply, service and support to our customers in Europe and across the world.
The Binding Site has its principal manufacturing and distribution facilities located in the UK. As an organisation we have undertaken various actions to ensure that any impact of the end of the Brexit transition period to customers is mitigated to the greatest extent possible. We have analysed our potential exposure and have put in place the following measures to ensure supplies to EU based customers are maintained.
Manufacture of Products and Supply Logistics – We have significantly increased our raw material stock holding levels to provide an additional buffer against supply issues for any raw materials sourced from outside of the UK or any delays at the borders. For customers based in the EU all finished products are supplied directly from our German and French warehouse locations, this model has been successfully operating since March 2019. Both facilities have been refurbished with significant increases in the cold storage capacity to ensure they can hold enough stock to service the EU customer base. We utilise air freight to transport our products to minimise transport times and avoid any potential border delays. Our ‘Authorised Economic Operator’ status shows the importance we place on demonstrating supply chain strength and security.
Regulatory compliance – Brexit will impact on products that are CE marked according to the In-Vitro Diagnostics Directive (IVDD). The CE mark allows free movement in the 30 EEA states which currently include the UK. From 1st January 2021, this will change as the UK exits the EU. The UK Government has agreed with the MHRA to recognise CE marking under the IVDD until the 30th June 2023. The Binding Site GmbH has been appointed as the Authorised Representative in Europe to allow The Binding Site to continue the placing of CE marked products in Europe under the IVDD. The Authorised Representative will also be responsible for vigilance for all products sold in the EEA states. All labelling for IVD assays has been updated to ensure regulatory compliance for 2021 and beyond. BSI Netherlands were appointed as our Notified Body within the European Union in 2019 as part of our preparation for introduction of the IVDR in 2022.
The analysis and preparations are correct as at the date of this and subject to change dependent on future EU/UK decisions relating to Brexit. The information provided is intended as a high-level summary only, and if you need more specific information please contact your usual Binding Site representative.