‘No-deal' Brexit preparedness: European Commission provides practical guidance on medical devices



These areas include citizens' residence and social security entitlements, data protection, medicine and medical devices, police and judicial cooperation in criminal matters, and fisheries. The aim of today's guidance is to ensure the smooth practical implementation of EU and national contingency measures, if the United Kingdom were to leave the EU without a deal on 12 April, or at a later date, ­and to maintain a coordinated approach throughout any such ‘no-deal' phase. A ‘no-deal' withdrawal will cause disruption and is not desirable, but the EU is fully prepared for it.

As outlined by President Juncker in the European Parliament on 3 April 2019, should a ‘no-deal' scenario occur, the UK would be expected to address three main separation issues as a precondition before the EU would consider embarking on discussions about the future relationship. These are: (1) protecting and upholding the rights of citizens who have used their right to free movement before Brexit, (2) honouring the financial obligations the UK has made as a Member State and (3) preserving the letter and spirit of the Good Friday Agreement and peace on the island of Ireland, as well as the integrity of the internal market.

Guidance in 5 areas

1. Citizens' residence and social security entitlements

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2. Police and judicial cooperation in criminal matters

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3. Medicinal products and medical devices

The medical sector has been a priority of the Commission's preparedness work from the very beginning, with guidance being issued already in July 2017. Thanks to preparedness measures, the majority of medicinal products concerned by the UK's withdrawal should now be compliant with EU legislation as of the UK's withdrawal date. It is possible, however, that despite best efforts some medicinal products and medical devices may not be compliant in time. There is, therefore, a risk of shortages if economic operators do not act swiftly to remedy the situation. Today's guidance highlights how the Commission will work with the European Medicines Agency (EMA) and national medicines regulators to monitor the situation closely and address any potential problems. It also outlines the possibilities for making use of exemptions and derogations available from the existing rules, in order to mitigate the risk of shortages of medicinal products and of critical medical devices in case of a ‘no-deal' scenario.

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