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16 June 2013

UDI, Eudamed and Medical Device Regulation

The European Commission published its recommendation for a common framework (...)
27 April 2013

The 2013 Revision Of The EU Vigilance Guidelines

Revision 8 of MEDDEV 2.12-1, the new European Medical Device Vigilance (...)
15 February 2013

EU Medical Device Regulation’s Scrutiny Procedure Could Hinder CE Marking Process

As soon as the European Commission published the proposed new European (...)
27 November 2012

The new French Decree: Advertising visa for high risk medical devices

The French decree regarding the list of medical devices for which (...)
27 September 2012

EU Medical Device Directive Revision - What’s going on ?

The publication of the Commission’s revision proposal to the Council and (...)

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13 June

July 1st 2017: New Notification Rules in France for Class 3 and 2b implantable Medical Devices

Modalities for the transmission of the Summary of the Characteristics of the Device Medical to ANSM
6 April

5 April 2017 - EU Parliament adopts new medical device and diagnostics regulations

5 April 2017 – The final vote of the European Parliament has endorsed the (...)
27 February

The Last Versions of the Future EU Regulations published on February 22, 2017

The Council has published on February 22, 2017 the last consolidated texts (...)
6 February

Additional information to provide to ANSM for Class III and Implantable MDs - July 1st 2017

Starting July 1st, 2017, ’When Class III and Implantable medical devices are (...)
20 June 2016

The consolidated negotiated texts for the medical device and the IVD regulations are available

The trilogue negotiations are completed and the proposal regulations (...)

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