May 01, 2020 - Changes in Manufacturer Incident Reporting
MIR rev. 7.2.1 release.
January 2020 "Help Text" (list of Annexes A to F codes) is still applicable,
but Annex G (components) has also been released from IMDRF website last May.
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MME News
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15 June 2020
VIGILANCE forms and annexes - May 2020 releases
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15 June 2020
MDCG Guidances releases
Latest releases - MDCG Guidances from DOC ROOM EUROPE
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27 May 2020
May 19, 2020 - Official Journal of the European Union
Official Journal of the European Union 2020 | C 171 | 1 May 19, 2020
COMMUNICATION FROM THE COMMISSION Guidelines on the adoption of Union-wide derogations for medical devices in accordance with Article 59 of Regulation (EU) 2017/745 (2020/C 171/01)
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8 May 2020
Mid April 2020 - MDCG Guidances release
April 15 - MDCG Guidances
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21 January 2020
MIR 7.2 and its A to F completed annexes
2020-January VIGILANCE _ MIR 7.2 and its A-to-F complete annexes
Last News
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1 August
The new transitional deadlines for medical devices
REGULATION (EU) 2023/607 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 15 March 2023 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices
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12 April 2022
EC Commission on April 11, 2022: The EUDAMED UDI/Devices module updated technical documentation is available
MEDIMARK EUROPE LAST NEWS: New announcement from the EC Commission on (...)
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15 February 2022
2022-01-25 Regulation 2022_112 amending IVDR - transitional provisions
IVDR : Amendment on transitional measures published on January 28, 2022.A (...)
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18 October 2021
2021-10-14 EU Commission proposal for the gradual roll-out of the IVDR.
The European Commission has proposed a gradual roll-out of the new IVDR (...)
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11 October 2021
MDCG 2021-24 Guidance on classification of medical devices
The Medical Device Coordination Group (MDCG) has just published in October (...)
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