Very first elements of the EMDN (European Medical Device Nomenclature)
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MME News
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21 January 2020
2020-01 More about The European Medical Device Nomenclature (EMDN)
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21 January 2020
End 2019 - NB notified for MDR and IVDR
End 2019 Final Stage of designations in NANDO - 9 NBs designations were published for MDR and 3 NBs for IVDR
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17 October 2019
MDR Eu-UDI summary
MDR European UDI summary by BSI
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10 October 2019
2019-10-10 IVDR-MDR NB Designation to date
At the best of our knowledge, today, October 10th : IVDR-MDR_NB designation
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1 October 2019
UDI - One page memo
Memorandum EU-UDIs (UDI-DI and UDI-PI) ; labelling
Last News
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16 December 2020
MME obtained its EAR SRN !
AR SRN just granted to MediMark Europe
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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
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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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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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