The GHTF releases a new version of the document from the previous year: GHTF SG5 – Clinical Evaluation – May 2007. The document has a similar structure to MEDDEV 2.7.1 …
2006 – GHTF-document of the Study Group 5
The GHTF releases the document SG5(PD)N2R7 of the Study Group 5 which deals with clinical evaluations.
2004 – ZLG-document for evaluation of clinical data
The German Central Federal Agency for Health Protection (ZLG) releases a document concerning evaluation of clinical data by the notified bodies. This document is also based on MEDDEV 2.7.1-„Goldstandard“. This means …
2003 – ISO 14155
The standard ISO 14155 Part I and II are going to be released and replace by that way the standard EN 540. The first part of the ISO 14155 describes …
2003 – response of the notified bodies
The notified bodies focus on the recommendations of MEDDEV 2.7.1 Guideline by verifying clinical evaluation as a part of technical documentation.
2003 – MEDDEV 2.7.1
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 …
Until 2003 – a need for interpretation concerning clinical data
It will become evident in the following years that different interpretations might occur concerning the requirements of the Directive 93/42/EEC with respect to various approaches of collecting and evaluating clinical …
1998 & 2002 – Amendments to the Act on Medical Devices
The Act on Medical Devices is being adapted by the first and second Amending Act on Medical Devices. The paragraphs 17 to 19 primarily continue to focus on the performance …
1990s – implementation of the Directive 93/42/EEC
The Medical Devices Directive 93/42/EEC (MDD) has been published by the Council on 14 June 1993 and is intended to harmonise the laws relating to medical devices within the European Union. …
1995 – Act on Medical Devices
The German Act on Medical Devices (MPG) will enter into force on 1 January 1995 and implements the European Directive 93/42/EEC on medical devices into national law. As a consequence …