BREXIT and the supply of medical devices: if you’re not prepared, take action now

On Jan. 1, 2021, the time finally came, and BREXIT – or the United Kingdom’s exit from the EU – came into effect, hard and inexorably. Suddenly, everyone involved realized how difficult it was to get previously simple shipments of medical devices across the channel. While importing into the UK in the first half of 2021 was still subject to a certain level of “technical ignorance” of applying the tough rules to UK imports, now both sides have set up their structures and as a result, all shipments between the two customs territories are now strictly held up if the accompanying documents are not correct, missing or incomplete.

And all this actually still happens. Many companies on both sides of the channel are not yet set up, or are set up very inadequately, to shorten the longer delivery times of products as much as possible. This applies on both the shipper and the recipient side. While Swiss hospitals have been aware of the import VAT problem for decades and also include the additional amount of time for a customs inspection in their orders from EU partners, many British hospital customers are still surprised that an overnight order is hardly possible anymore or only with very good preparation on both sides and significant extra effort.

This “Brexit-ignorance” of some parties has consequences for the entire European handling of shipments. UPS Small Package Germany, for example, handles all express shipments leaving or arriving in Germany in its Cologne hub. Due to many mishandled UK parcels, almost all express shipments have been delayed the last few months, and there is even a higher number of total losses, as the Brexit meets a massive increase in the volume of shipments due to stronger online trade.

How to handle this situation?

Set up your shipping processes and associated customer communications to either meet or manage customer expectations. Check your processes for Brexit readiness:

  • Are your products prepared for UKCA/CE mark?
  • Have you installed Authorized Representatives and IOR (Importer of Record) in both jurisdictions?
  • Has the labeling been adjusted?
  • Do you have all customers’ EORI numbers available in the other jurisdiction?
  • Have all customers been informed about any extended delivery times and thus the need for an increased in-house inventory?
  • Do you have a clear strategy for communication to your sales representatives and updated your sales team training protocols ?

Kalms Operations – your strong and experienced partner

Kalms Operations is an experienced third-party logistics and fulfillment provider specializing in small, medium and high-growth shipment volumes. Our consultancy-based background helps you deal with Brexit challenges in your supply chain. We are your strong fulfillment partner for your medical devices in the EU and beyond. Contact us to see how we can help you succeed.

Author's Photo

Gerald Schröder is an Executive Vice President and Head of the Kalms Operations Business Unit at Kalms Consulting GmbH. He has also completed an additional qualification as “Manager Regulatory Affairs Medical Devices International (TÜV Rheinland & Ulm University of Applied Sciences)”.

Gerald Schröder

Head of Business Unit Kalms Operations

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