As you all know, the UK is set to leave the European Community on 31 October 2019. And the outcome of this decision is still uncertain, but rest assured Medline is working hard to make sure all of our customers remain unaffected. There are two main issues at hand: availability of products in the UK due to potential issues at the border, and the validity of CE-marked products for the UK and mainland Europe alike.
As a key supplier to the NHS and private healthcare providers in the UK, Medline has put plans in place to ensure continuity of supply. Our warehouse in Bicester, Oxfordshire, is stocked with 98 per cent of all UK products, and since April, we have been fulfilling orders and shipping to customers from this location. All UK orders will ship from Bicester for as long as there remains a risk of delays at the border.
There are no changes to the ordering process itself, and customers should continue to send orders to Medline Customer Services via the normal route. Should customers require further information or details on a specific order, they can contact our Customer Services team on 0800 151 3587 or via email on [email protected].
Medline will continue to monitor the situation closely and will provide further updates as and when appropriate.
CE marking is a certification mark that indicates conformity with health, safety and environmental protection standards for products sold within the European Economic Area. In the event of a no-deal Brexit, CE certificates issued in the past by UK notified bodies will no longer be valid in the UK or in the EU for placing products on the market. Companies will need to transfer their CE certificates to notified bodies designated by one of the EU 27 member states.
Medline has already started to implement some actions to ensure our products are properly certified in the UK and the rest of Europe:
For product sales in mainland Europe
- Firstly, our notified body changed from BSI UK to BSI Netherlands; therefore, the notified body number changed from 0086 to 2797 for medical devices. Medline has updated their certifications, and device labels will be updated over a period of two years. Customers can already see some product labels with the logo CE 2797.
- The certifications for personal protective equipment that are currently with BSI UK will be issued by BSI Netherlands in the coming weeks. The labels will be updated over a period of two years as well.
- Medline has contacted all our suppliers and distributors who have UK notified bodies asking them to start the migration process to another notified body.
For product sales in the UK
- Medline is currently working on obtaining an Authorised Representative in the UK (UK Rep). Medline devices will have to go through a separate registration process in order to maintain sales in the UK.
We will keep this information updated on a regular basis.