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15 July 2019

July 2019 - More about NBs

2019-07-15 - More about Notified Bodies out or in the run for MD/IVDR...
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
22 June 2019

About MDR NBs and others

About NBs
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
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

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20 July 2021

UDI : Two New Guidances for Manufacturers

UDI : The two last MDCG Guidances for implementing the UDI into your (...)
15 January 2021

EU DG SANTE about Brexit

Jan 15 2021 EU DG SANTE position about Brexit
16 December 2020

MME obtained its EAR SRN !

AR SRN just granted to MediMark Europe
16 December 2020

MDCG 2020-16 : 7 rules of classification for IVD 4-risk classes devices

2020-NOV MDCG 2020-16 Guidance on Classification Rules for ivd MDs under 2017-746_en
17 September 2020

2020-SEPT-17 _ A 17th NB accredited for MDR

2020-SEPT-16 _ 3EC International, Slovakia, becomes the 17th NB accredited for MDR under ref NB-2265

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