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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13 September 2020
2020-SEPTEMBER-29 - Day of Free Webinar offered by BSI about Brexit and MHRA guidance released last Sept 01 & 04 2020
Free one-hour webinar offered by BSI experts on MHRA last early September released guidance and UK "brexiting issues" regarding all medical devices to be ready for no later than next January 01, 2021 !
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4 September 2020
2020-SEPT MHRA - NEW RULES FROM 01 JANUARY 2021
2020-09-01 and 04 - MHRA UK - post-transtion period -Medical, Clinical and medicinal - NEW RULES FROM 01 JANUARY 2021
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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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