The Working Group on Technical Barriers to Trade, assisted by the Expert Group on Medicinal Products and Medical Devices, is responsible for legislation on medical devices contained in Annex II, Chapter XXX of the EEA Agreement.
The Expert Group delegates participate in the Commission’s Medical Device Coordination Group (MDCG).
The medical devices sector covers approximately 8000 types of products, ranging from simple bandages and spectacles, life-saving implantable devices, equipment for screening and diagnosing disease and health conditions, to the most sophisticated diagnostic imaging and minimal invasive surgery equipment. The EEA EFTA States are mainly involved in the regulatory framework for market access, international trade relations and regulatory convergence, and the competitiveness of industry. The legislation defines the essential requirements that medical devices must meet before being placed on the market, the conformity assessment procedures and mechanisms available to national competent authorities to manage implementation or to intervene on the market when reasons of public health so require.
In order to establish a modern and robust framework which ensures better protection of public health and patient safety, the EU has adopted progressive rules on medical devices (Regulation (EU) 2017/745 and Regulation (EU) 2017/746).
DG Internal Market, Industry, Entrepreneurship and SMEs (DG GROWTH) - Medical devices