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MDR Eu-UDI summary
MDR European UDI summary by BSIDear Partners,Please find here attached a summary of the European UDI process, From UDI-DI that will have to feature on DoC asap, and be obtained even for "Legacy...
View ArticleApril 17th EU parliament voting MDR postponing
MDR 2017/745 postponed till May 2021Dear Partners,You will share with us the news available from https://www.europarl.europa.eu/plen... that confirms proposal C9-0098-2020 (Medical Devices) has been...
View ArticleNew ISO 9001-2015 Certificate for MediMark Europe
MediMark Europe is re-certified to ISO 9001:2015 by DNV-GL for its European Authorized Representative activities for medical devices and in vitro diagnostic devices. This certificate is valid until 07...
View ArticleMid April 2020 - MDCG Guidances release
April 15 - MDCG GuidancesDear Members, Here are thereafter and attached in PDF format four MDCG (not binding) guidances released last mid April regarding subjects you might find of interest. 2020-04-23...
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May 2020 - 17th Notify Body designated by NANDO
May 2020 - 17th Notify Body designated by NANDOMDR : 14 Notified Bodies..Specific fields for accredition can be found on NANDO website (hlm and PDF are available) :...
View ArticleMay 19, 2020 - Official Journal of the European Union
Official Journal of the European Union 2020 | C 171 | 1 May 19, 2020COMMUNICATION FROM THE COMMISSION Guidelines on the adoption of Union-wide derogations for medical devices in accordance with Article...
View ArticleSearching for a NANDO designated NB ?
NANDO is publishing a list of NBs designated for MDR and IVDR auditing.Lists are available from EUROPA (GROWTH) website and permanently updated. Here below are the useful e-address where to start your...
View ArticleJanuary 2020 MIR form rev 7.2 and its Annexes
Starting January 01, 2020, the management of vigilance event made the use of a new form compulsory, which is so far MIR rev. 7.2.And to use it, publishing was made too of an updated "Help Text" (list...
View ArticleMDCG Guidances releases
Latest releases - MDCG Guidances from DOC ROOM EUROPEDear Members,.Here are thereafter and attached in PDF format four MDCG (not binding) guidances released last May and June 2020, regarding subjects...
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VIGILANCE forms and annexes - May 2020 releases
May 01, 2020 - Changes in Manufacturer Incident ReportingMIR 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...
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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 ArticleIn Vitro Diagnostic Medical Devices
In order to give flexibility to the IVD manufacturers for a progressive introduction of their product lines into the European Market, the fee structure is constituted of an annual administrative fee...
View ArticleMedical Devices
In order to answer to the different levels of risks of Incidents associated with the various types of Medical Devices, MediMark® Europe proposes two different options for US Manufacturers.Services...
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...
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