What happened to the European Single Market?
The United Kingdom left the European Union and is now a Third Country. As a result, the UK has developed its own regulatory system for medical devices and IVDs. However, causing further complexity, only three of the four UK countries will follow this new system. One of them will continue to require CE Marking.
The Mutual Recognition Agreement between Switzerland and the EU lapsed for medical devices. As a result, Switzerland was forced into a last-hour update of its legislation, due to now being a Third Country.
The above changes have caused tremendous confusion in the regulatory world, including questions such as:
How does the European Economic Area (Iceland, Liechtenstein and Norway) and Turkey fit into this new version of the European Single Market?
Are there still common requirements between the EEA/EU, Turkey, UK and Switzerland?
What is staying the same and what has changed?
POWERPOINT: Requirements Throughout Europe