2019-07-15 - More about Notified Bodies out or in the run for MD/IVDR...
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MME News
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15 July 2019
July 2019 - More about NBs
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11 July 2019
2019-07-11 Updated EU Vigilance general guidelines
Additional Guidance Regarding the Vigilance System as outlined in MEDDEV 2.12-1 rev. 8
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22 June 2019
About MDR NBs and others
About NBs
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1 March 2019
2019 FSCA Management and Meddev FSN forms
Meddev guidelines and templates for the management of FSCA and recalls in Europe Application : 2019
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18 January 2019
2019 Revision of Manufacturer Incident Report
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
Last News
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3 September 2020
September-03-2020 Updated list of NANDO NBs
September-03-2020 Updated list of NBs notified under EU Regulations on MD and IVD and their detailed framework.
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21 August 2020
EU 2020/1207 rules for 2017/745 - specifications for the reprocessing of single-use device
Commission Implementing Regulation (EU) 2020/1207 of 19 August 2020 laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards common specifications for the reprocessing of single-use device.Released 20 August 2020
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22 June 2020
Fourth NANDO Designation - IVDR NB
TÜV SÜD designation for IVDR
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27 May 2020
May 2020 - 17th Notify Body designated by NANDO
May 2020 - 17th Notify Body designated by NANDO
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7 May 2020
New ISO 9001-2015 Certificate for MediMark Europe
Company:MEDIMARK EUROPE Sarl / Site Name:MEDIMARK EUROPE SarlAddress:11 Rue Emile Zola, Grenoble, France (Metropolitan)
Certificate #:10000244364-MSC-COFRAC-FRAAccreditation:COFRAC
Standard:ISO 9001:2015
Status:Issued/Current
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