The European Union is in transition now due to some regulatory changes. EU MDR will be applicable by May 26th, 2021, but in the meantime, other political situations may impact this timeline.
Manufacturers that would like to register their product in Europe need to understand the potential situations that could happen and how this can change your regulatory strategy.
Brexit will apply by January 1st, 2021. Swixit and Turkxit will depend on the EU commission, but this may happen by May 26th, 2021.
This presentation takes a dep dive into the implications of Brexit, Swixit, Turkxit for the European Medical Device Market.