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Fourth NANDO Designation - IVDR NB
TÜV SÜD designation for IVDRDear All,We are pleased to announce the notification of TÜV SÜD under the number NB 0123, as a Notified Body for IVDR.The 4 IVDR ONs are now : DEKRA DE BSI NL BSI UK TÜV SÜD...
View ArticleEU 2020/1207 rules for 2017/745 - specifications for the reprocessing of...
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...
View ArticleSeptember-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.Dear All, A new NB had lastly been notified under EU Regulation 2017-745, which is GMED...
View Article2020-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 2021Dear Partners, UK MHRA has just released last September 01, 2020, with additional...
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2020-SEPTEMBER-29 - Day of Free Webinar offered by BSI about Brexit and MHRA...
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...
View Article2020-SEPT-17 _ A 17th NB accredited for MDR
2020-SEPT-16 _ 3EC International, Slovakia, becomes the 17th NB accredited for MDR under ref NB-2265Dear Partners and friends,.We are glad to be able to announce almost the day it was published that a...
View ArticleMDCG 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 Please follow-up guidance and helptext in your private members area ! Best, MME team - Last News
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MME obtained its EAR SRN !
AR SRN just granted to MediMark EuropePlease don't hesitate to visit the dedicated webpage in your Private Members Area to know how it will help you with : your own application(s) - one per role your...
View ArticleEU DG SANTE about Brexit
Jan 15 2021 EU DG SANTE position about BrexitEurope's sante Newsroom - Brexit Jan 15 last newsDirect website access is : https://ec.europa.eu/newsroom/sante...Last December 31 MHRA releases...
View ArticleHistoric, references, key people
MEDIMARK® EUROPE has been created early 1995 by René Clement in order to fulfil the need for non- European Manufacturers of Medical Devices to designate an official European Authorized Representative...
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