The UK Government has decided not to extend the transition period for leaving the EU, which means that the UK will fully leave the EU on December 31st 2020. What does this mean for the industry?
For medical devices there will be a level playing field when it comes to safety and performance. UK medical device manufacturers must adhere to EU legislation if distributing products in Europe, even up to the level of EU Notified Bodies performing audits on UK territory.
In a recent notice, the European Commission (EC), European Medicines Agency (EMA) and Heads of Medicines Agencies (HMA) reminded clinical trial sponsors that they must comply with EU clinical trial rules following the Brexit transition period that expires on 31 December 2020.
Most importantly, according to Article 13(2) of Directive 2001/20/EC, the qualified person has to be established in the EU. Investigational medicinal products used in clinical trials can be imported only after their batch-release has been certified by a qualified person in the EU.
There are companies that rely on cross-Channel supplies of critical raw materials or components. Many companies have been preparing for a no-deal Brexit, and now have limited time to take final preparatory measures like building stock or contacting other sources of supply. Alternatively, they can hope for a last-minute solution that would prevent a no-deal situation.