The European Commission published its recommendation for a common framework (...)
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MME News
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16 June 2013
UDI, Eudamed and Medical Device Regulation
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27 April 2013
The 2013 Revision Of The EU Vigilance Guidelines
Revision 8 of MEDDEV 2.12-1, the new European Medical Device Vigilance (...)
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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 (...)
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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 (...)
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27 September 2012
EU Medical Device Directive Revision - What’s going on ?
The publication of the Commission’s revision proposal to the Council and (...)
Last News
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12 June
France Simplifies Regulations for Implantable and Class III Devices
Decision of the Council of State: The RCD decree concerning the need to send to ANSM, the French NCA, a summary of the characteristics for Class 2b implantable and 3 devices, has no legal basis and can only be canceled.
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4 May
Class 1 Reusable Surgical Instruments : Mandatory Conformity Assessment by a Notified Body
The article 52 ( 7) of the new EU Medical Device Regulation 2017/745 requests the involvement of notified bodies for Class 1 Reusable Surgical Instruments.
The involvement of a NB was only mandatory under the current MD Directive 93/42/EEC for Class 1 sterile and Class 1 with a measuring function.
For Class 1 Reusable Surgical Instruments, the NB will deliver a CE Certificate for the aspects relating to the reuse of the device, in particular cleaning, disinfection, sterilization, maintenance and functional testing and the related instructions for use
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15 February
New adverse event terminology to be implemented in Europe starting from 2Q 2018
The European Competent Authorities are keen to receive codified information (...)
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15 November 2017
November 2017 : Team-NB Notified Bodies members’ intention to submit application to be designated against the new MDR and/or IVDR
In the framework of the new Medical Device Regulations, you will find (...)
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13 June 2017
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
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