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In November 2017 the 2016 edition of EN ISO 13485 was harmonized edition under the European Directives 93/42/EEC on medical devices and 98/79/EC in vitro diagnostic medical devices. Therefore this...

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The current version of the guidance document MEDDEV 2.7/1 was published as Revision 4 on the website of the European Commission end of June 2016. This document includes the methodology to conduct a...

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After negotiations that extended over years, the new regulations for medical devices (Medical Device Regulation, MDR) and in-vitro diagnostic medical devices (In-Vitro Diagnostic Medical Devices...

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In March 2016 the new revision of ISO 13485 was published. In contrary to ISO 9001:2015 the ISO 13485:2016 does not follow the ISO high level structure. In addition no reduction of requirements was...

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After the publication of ANSM now Swissmedic published a procedure in order to give manufacturers located in Switzerland, whose Notified Body terminated his activities due to de-notification or other...

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According to an information sheet and a list of questions and answers issued by the French Competent Authority ANSM there is a possibility for manufacturers, whose Notified Body terminated his...

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Publication of the german Federal Ministry of Health (2016-06-15) and special rule of the Land authorities responsible for medical devices and the Central Authority (2016-06-24)

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