FDAnews Device Daily Bulletin
Medical Devices / Regulatory Affairs

UK Gets Halloween Extension, But Brexit is Still Scary

April 16, 2019
A A

British Prime Minister Theresa May won yet another delay from European leaders on the UK’s exit from the EU, leaving devicemakers no clearer about the ultimate impact of Brexit on the supply chain.

May now has until Oct. 31 to come up with an agreement for a post-EU future. A hard Brexit—a divorce without any kind of agreement—would mean that device companies used to testing their products in the UK will find themselves on the outside looking in, because EU law requires testing in member countries.

On April 10, ahead of the extension, the European Commission did its best to calm nerves saying that most medical products would likely be compliant with EU regulations if the UK crashes out of the union without a formal agreement.

“It is possible, however, that despite best efforts some medicinal products and medical devices may not be compliant in time,” the commission added. “There is, therefore, a risk of shortages if economic operators do not act swiftly to remedy the situation.”

View today's stories