UKCA marking | A Regulators Perspective on Clinical Evaluations and Investigations

Accessing the European and UK markets bring challenges that can lead to delays in your product launch. Such delays can be costly for the manufacturer, and for patients who require care. However, there are stringent requirements in place to ensure patient and user safety, as well as the performance of the device. 

Learning Objectives 

• A regulator’s thought on the new clinical evaluation requirements – does it solve the problem? 

• What are the key challenges for the regulator in implementing the new requirements? 
• The UK – a regulator with ‘two halves’. What are the implications for the UK, and what happens in 2023