Manufacturer Incident Report (MIR)for Serious Incidents (MDR/IVDR) and Incidents (MDD/IMDD/IVDD)
Reporting Template Version 7.0 EU Medical Devices Vigilance SystemGuidelines and Annexes
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MME News
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18 January
2019 Revision of Manufacturer Incident Report
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16 June 2013
UDI, Eudamed and Medical Device Regulation
The European Commission published its recommendation for a common framework (...)
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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 (...)
Last News
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7 January
2019-01-04 From GOV UK : Guidance note on the regulation of medical devices if there’s no Brexit deal
BREXIT: What will happen after March 29, 2019 in case of no deal ?
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17 December 2018
Communication Campaign’ of the European Commission – factsheets and infographics supporting IVDR/MDR implementation Posted on 06.12.2018
European Commission published a series of factsheets and infographics as (...)
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10 October 2018
10 October 2018 - About Brexit and NB, EAR and distributors located in UK
From : EUROPEAN COMMISSION RELEASE - Brussels, 22 January 2018 - REV.1
NOTICE TO STAKEHOLDERS WITHDRAWAL OF THE UNITED KINGDOM AND EU RULES IN THE FIELD OF MEDICAL DEVICES
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12 September 2018
Implementation of Medical Devices EU-Regulation
MediMark Europe has made a selection of documents which may help you to (...)
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12 June 2018
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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