A revision of MEDDEV!
MEDDEV 2.7.1 Rev.3 is going to be released on the website of the EU Commission. The amendments announced were implemented and the document is completely revised.
Thereby it can be considered as a new version.
The new document includes many more specific aspects than the previous one and is largely identical to the recommendations of the SG5 from GHTF
(see GHTF SG5 – Clinical Evaluation – May 2007).
In addition to the requirements for clinical evaluation we also find a description of the demands on the notified body and consistent terminological definitions being used.
Furthermore the annexes of the document contain examples of how requirements are implemented.
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 which have been taken over often verbatim 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.