Information on Brexit for manufacturers, importers and distributors of medical devices

The United Kingdom submitted on the 29th of March 2017 the notification of its intention to withdraw from the European Union. This means that, unless a ratified withdrawal agreement establishes another date or the period is extended by the European Council in accordance with article 50(3) of the Treaty on European Union, the United Kingdom will become a 'third country' and all Union primary and secondary law will cease to apply to the United Kingdom from the 30th of March 2019, 00:00h (CET), the withdrawal date. If there is an extended date of withdrawal from the EU, the information is applicable from that date.

In view of the considerable uncertainties, in particular concerning the content of a possible withdrawal agreement, economic operators as well as healthcare institutions are reminded about the legal repercussions for medical devices, which need to be considered when the United Kingdom becoming a third country.

For medical devices this will specifically have an impact on medical device manufacturers with an authorised representative in the United Kingdom, medical device manufacturers in the United Kingdom that intend to place devices on the EU market and medical device manufacturers with EC certificates issued by notified bodies located in United Kingdom but all medical devices could be affected due to customs, supply of components etc.

Legal consequences if the United Kingdom leaves the EU with no deal

Medical device manufacturers outside of EU need to have an authorised representative within EU to place a device on the EU market.

  • Medical device manufacturers that have an authorised representative in the United Kingdom need to change to an authorised representative in EU to place devices on the EU market
  • Medical device manufacturers in the United Kingdom need to have an authorised representative in EU to place devices on the EU market

Medical devices in higher risk classes need to have an EC certificate issued by a notified body located within the EU to be placed on the EU market.

  • Medical device manufacturers with a notified body in the United Kingdom need to change to a notified body within EU to place devices on the EU market.

Operators who were previously considered distributors when the importer or distributor was in the United Kingdom might become importers and will have to adhere to all importer obligations.

Medical devices already placed on the market with an authorised representative or a notified body in the United Kingdom before the withdrawal of the United Kingdom from the EU can continue to be made available on the EU market after the withdrawal.

When is it necessary for a manufacturer with a notified body and/or an authorised representative in the United Kingdom to have changed to a notified body/authorised representative in the EU?

If the United Kingdom leaves the EU after the 29th of March manufacturers need to have an authorised representative and a notified body in the EU the 30th of March to place devices on the EU market. If the period for withdrawal is extended manufacturers need to have changed authorised representative/notified body to the new withdrawal date. Be aware of that a withdrawal agreement or any other results of the negotiations between the United Kingdom and the EU could lead to other legal consequences.

Actions to be taken by manufacturers

  • Manufacturers located outside of the European Union with an authorised representative in the United Kingdom should prepare for a possible change to an authorised representative located within the European Union to be in compliance with the EU medical devices directives. As the new medical device regulations soon will be applicable manufacturers should take into account the new requirements set up in article 11 of the medical devices regulations 2017/745/CE and 2017/746/CE.
  • Manufacturers of medical devices or in vitro diagnostic medical devices placed on the market with certificates issued by notified bodies in the United Kingdom should prepare for a possible transition to a notified body located in the European Union.
  • Manufacturers in the United Kingdom should prepare for a designation of an authorised representative located within the European Union to be in compliance with the EU medical devices directives.
  • Develop a “Brexit impact scan” to assess dependencies in own “supply chain”
    • Which products, materials, resources etc. have origin in the United Kingdom?
    • Which alternatives are available?
    • Other dependencies: service contracts, data storage, registries
  • Proactively inform customers, clients and patients on possible delays/shortages and proactively check with supplier on possible disruptions and alternatives.
  • Investigate the possibility to build up stocks on the EU market. Devices placed on the EU market before the withdrawal of the United Kingdom can continue to be made available on the EU market.
 
 
 

Swedish Medical Products Agency, P.O. Box 26, SE-751 03 Uppsala, SWEDEN | +46 18 17 46 00 | registrator@lakemedelsverket.se | Contact information