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Category Archive

MEDDEV 2.7/1 revision 4 released

In News, μ-Blog by F.Tolkmitt30. June 2016Leave a Comment

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, …

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MEDDEV-revisions (slowly) progressing

In News, μ-Blog by F.Tolkmitt16. January 2014Leave a Comment

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 …

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A new legislation for MEDDEV-Requirements

In News, μ-Blog by F.Tolkmitt30. May 2013Leave a Comment

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 …

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2009 – 4th version of the Medical Devices Act

In News, μ-Blog by F.Tolkmitt28. February 2009Leave a Comment

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) …

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2008 – MEDDEV 2.7.1 Annex I

In News, μ-Blog by F.Tolkmitt25. March 2008Leave a Comment

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 …

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