The GHTF is publishing recommendations for conducting Post-Market Clinical Follow-up (PMCF) Studies: GHTF SG5 – Post-Market Clinical Follow-Up Studies – November 2009.
2009 – MEDDEV 2.7.1 Rev. 3
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. …
2009 – ISO 14155 revision
The ISO standard 14155 part I and II will be released in a new version and replace the latest versions of 2003.
2009 – announcement of MEDDEV revisions
It has been announced, that the MEDDEV documents are going to be revised in order to comply with the requirements of the directive 2007/47/EC. This also concerns the MEDDEV 2.7.1 …
2009 – replacement of the MEDDEV documents
Insiders believe that MEDDEV documents will be soon replaced by GHTF documents.
2009 – 4th version of the Medical Devices Act
The Act on Medical Devices is going to be released in its 4th version. (s. MPG) and supports the implementation of the directive 2007/47/EC. Medizinproduktegesetz The Medical Devices Act (abbr. MPG) …
2009 – NBOG-document for evaluation of technical documentations
The Notified Body Operations Group (NBOG) has released the document for evaluation of technical documentation (NBOG BPG 2009-4) which refers back to evaluation of clinical data. Picture Source: Pilgrim Software They …
2008 – draft version for clinical studies by the GHTF
The GHTF releases a draft version of the document SG5(PD)N1R7. In this document the GHTF takes position to the performance of clinical studies/clinical trials for the first time.
2008 – MEDDEV 2.7.1 Annex I
The EU Commission has released MEDDEV 2.7.1 Annex I, which is especially about coronary stents. The requirements for stents are considered separately because of technical advances which need a different …
2007 – Council Directive 2007/47/EC
The Council Directive 2007/47/EC has recently been released by which the Council Directive 93/42/EEC is amended. The amended directive becomes effective on 21 March 2010. The amendments shall be implemented into …