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 …
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) …
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 …