By the end of June 2016 the 4th revision of MEDDEV-Guideline for clinical evaluations was released on the Webseite of the EU-Commission. There is no transition time mentioned in the document. However, …
MEDDEV-revisions (slowly) progressing
The working group “Clinical Investigations and Evaluation (CIE)” has been working on updates of the MEDDEV-Dokuments for the past months. While there was no progress on MEDDEV 2.7.2, a draft …
A new legislation for MEDDEV-Requirements
A new legislation for MEDDEV-Requirements Since mid-2012 the draft version of the new EU regulation is being controversially discussed. Besides the time frame for implementation of the regulation, it is …
Must we face a serious of regulations for clinical evaluation report soon?
Lawyer Susanne Valluet from the office Simmons & Simmons LLP about the Medical Device Regulation MDR Must we face a serious of regulations for clinical evaluation report soon?
2012 – GHTF documents about IVDs
By the end of 2012 the last GHTF documents of the SG5 are going to be published. These are: GHTF SG5 Clinical Evidence for IVD Medical Devices – November 2012 …
2012 – GHTF moves to disband
By the the end of the year 2012 the Global Harmonization Task Force GHTF suspends its activities. Prior to that there will be released a series of GHTF documents. The …
2012 – GHTF reports during clinical investigations
In 2012 just before the end of the GHTF a document with recommendations for further steps handling reports during clinical investigations is going to be published. source of image: University …
2012 – ISO 14155
In 2012 the renewed revision of the standard DIN EN ISO 14155:2012 for planning and conducting clinical trials is released. Formerly Part I and II are now combined in one …
2011 – foundation of IMDRF
By the end of 2011 the IMDRF (International Medical Device Regulators Forum) was founded as successor body of GHTF. The body consists only of authorities representatives.
2010 – GHTF clinical investigations
The draft-document towards clinical investigations of 2008 is going to be finalized and published in 2010. GHTF SG5 – Clinical Investigations – February 2010