Medical Devices and in vitro diagnostic tests must have a CE Mark before you can place them on the European (including UK) market. This includes digital health products and Apps, if they meet the definitions in the regulations.
We will advise you whether your product requires a CE Mark. If it does, we will help you develop a strategy and plan to comply with the the new Regulations (in force May 2017), device classification and conformity route.
We will also help you compile your Technical File and, if you haven’t got them already, help prepare and implement the Quality Management Systems and Procedures demanded by the regulatory authorities to demonstrate compliance.
We support you through the process of obtaining a CE Mark for your medical device or in vitro diagnostic device where this is required.
So, if you are unclear about your regulatory obligations, why not drop us a line for a free consultation.
Full details on our Contact page