The EU regulatory system for medical devices outlined in the Medical Device Regulation (MDR) and In-Vitro Diagnostics Regulation (IVDR) represents an important evolution over the previous legislation, seeking to ensure appropriate levels of protection of public health are in place for European citizens, creating an environment to allow access and innovation of new technologies and affording a predictable, consistent and sustainable regulatory framework.
The Regulations were proposed to update, address gaps and better define the regulatory requirements, particularly in relation to notified bodies, post-market requirements and clinical data, with the backdrop of several high-profile safety issues relating to implanted medical devices.
The medical device competent authorities believe that these Regulations are essential to improve confidence and provide a solid basis for enhancing and protecting public health by ensuring safety while supporting development and access to new technologies in Europe.
It is clear however that there are challenges in applying the Regulations for all stakeholders and the competent authorities are strongly committed to work to resolve issues, develop and secure the regulatory system.
Medical device competent authority statement on the status of the EU regulatory system