Glossary: EU Glossary

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EUDAMED: European Database on Medical Devices

EUDAMED will be an information system for exchanging legal information related to the application of European Union Directives on medical devices between the European Commission’s Enterprise and Industry Directorate General and the Competent Authorities in the European Union Member States. Its legal basis is laid down in Directives 90/385/EEC, 93/42/EEC, 98/79/EC and 2000/70/EC.

European Commission (EC)

The European Commission is the EU’s executive body. It represents the interests of the European Union as a whole and not individual countries.

The Commission’s main roles are to:

  • propose legislation which is then adopted by the co-legislators, the European Parliament and the Council of Ministers
  • enforce European law (where necessary with the help of the Court of Justice of the EU)
  • set a objectives and priorities for action, outlined yearly in the Commission Work Programme and work towards delivering them
  • manage and implement EU policies and the budget
  • represent the Union outside Europe (e.g. negotiating trade agreements between the EU and other countries)

ISPOR

International Society for Pharmacoeconomics and Outcomes Research (ISPOR), an international organisation promoting the science of pharmacoeconomics and health outcomes research.

Marketing Authorisation Holder (MAH)

The MAH is the company in whose name the marketing authorisation has been granted. This party has responsibility for all aspects of the product, including quality and compliance with the conditions of the marketing authorisation.

Notified Body

A notified body, in the European Union, is an entity that has been accredited by a Member State to assess whether a product to be placed on the market meets certain preordained standards.

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