29th September 2018 – Revised 1st October 2020
On 31st January 2020 the United Kingdom officially left the EU at 23:00. This triggered an 11 month transition period during which time the EU laws remain in effect while the UK government agrees the future relationship with the EU.
Shortly after our exit and at a crucial time for negotiations, the COVID pandemic spread across the UK and Europe and has understandably drawn focus away from Brexit. The government however has announced there will be no extension to the transition period and there remains significant uncertainty.
As a European manufacturer of medical devices, Reliance Medical benefits from the free market and regulatory harmonisation that membership to the EU brings. This will come to an end unless a suitable trade deal is implemented and for this reason Reliance Medical are forming a subsidiary company in Ireland to enable ongoing access to the European markets.
Additionally, to ensure continued compliance with EU regulations, we engaged with a German notified body and completed the transition of products to their oversight shortly after the outcome of Brexit became clear. Our products will therefore remain in compliance with EU law after 31st December 2020 regardless of any trade negotiations.
For the UK market, the government has announced that products that comply with European requirements after 31st December 2021 can continue to be placed on the UK market for a period of time; for medical devices this will be until December 2023. From this point the UKCA mark will be necessary, however until the government designate UK approved bodies, responsible for product assessment, we can only plan the transition.
We are fortunate that the majority of goods we manufacture and source originate from our wholly owned subsidiary in Shanghai. We therefore consider the concerns around border issues to be a minor risk at this time.
For further information, please contact our Chief Technical Officer, Paul Knox, on 08456 448808.