Competent Authorities for Medical Devices

Informal meeting of regulatory authorities from European Economic Area-EEA countries (EU Member States, Iceland, Liechtenstein and Norway) competent for medical devices.

The sector for medical devices of the European Commission is also invited to the meeting. The meeting is an effective and important way to improve cooperation between national authorities in order to meet this goal.

Four issues that will be on the agenda:

• Issues related to the implementation of the revised medical devices directives.
• Borderline and classification issues regarding medical information systems.
• We seem to need a declaration of content for medical devices that are designed for intimate contact with human tissues.
• The need for exchange of views with other sectors having a regulatory structure analogous to the medical devices sector.