The European Commission releases the first MEDDEV 2.7.1 document in cooperation with representatives of authorities, notified bodies and industry.
The guideline lists the requirements for clinical evaluations/clinical trials. The document has no legally binding character
but becomes quickly golden standard concerning clinical evaluations.
The European Commission or EU Commission is a supranational institution of the European Union. In the political system of the EU the Commission plays the executive role, which means being in charge of decision-making process of EU legislative acts (guidelines, regulations, resolutions of the European Parliament). The Commission’s right of initiative entitles the body to draw up proposals for a new legislation.
The MEDDEV-document is based on a document of the GHTF – an international organization – which results in the adoption of terms and definitions determined by the GHTF and is often reflected literally in several passages. However the documents have a different focus: whereas the MEDDEV-document provides a guidance for manufacturers and notified bodies on documenting and reviewing the clinical evaluation based on clinical data, the GHTF-document concentrates primarily on how to conduct clinical evaluation including practical help.