Medical device manufacturers are required to comply with Medical Devices (...)
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MME News
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15 March 2010
Revising Directive’s Time-of-Use Clause May Cause Reclassification of Devices
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7 January 2010
European Commission Publishes New MEDDEV Guidelines
The end of 2009 turned out to be a very prolific period for the publication (...)
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31 October 2009
Device Directive Revisions - It is time to revise your labels and IFUs - Phtalate Symbols
In our previous edition, we published a comprehensive glossary of revisions (...)
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31 March 2009
Medical Device Directive 2007/47/EC: Changes to MD 93/42/EEC. Application date: March 21, 2010.
The most important changes are the requirements of clinical data and design (...)
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31 January 2009
Bar Coding for Medical Devices Is Becoming a Regulatory Requirement
For many years, medical device manufacturers primarily used bar codes (...)
Last News
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19 March 2019
BREXIT ISSUES - 2019-03-19 MHRA last update _ vs EU Com release dated Feb 01st
MHRA March 19th 2019 Update about Brexit Issues confronted to EU Com last release about (how to manage) Brexit issues.
Complementary points of views, even if some zones of confusion still exist due to the general historical and even more to the current context, as you may guess.
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7 March 2019
2019-03-04 EUDAMED code chosen is Italian CDN
2019-03-06 - European Commission: CND replaces GMDN for DM nomenclature
The European Commission published on March 4, 2019, a document on the nomenclature of medical devices.
_ The surprise is that the GMDN ("Global Medical Device Nomenclature") was not finally selected by the European Commission:
it is the CND ("Classificazione Nazionale dei Deviceivi medici"), a nomenclature established by the Italy, which will be used for EUDAMED. -
7 January 2019
2019-01-04 From GOV UK : Guidance note on the regulation of medical devices if there’s no Brexit deal
BREXIT: What will happen after March 29, 2019 in case of no deal ?
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17 December 2018
Communication Campaign’ of the European Commission – factsheets and infographics supporting IVDR/MDR implementation Posted on 06.12.2018
European Commission published a series of factsheets and infographics as (...)
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10 October 2018
10 October 2018 - About Brexit and NB, EAR and distributors located in UK
From : EUROPEAN COMMISSION RELEASE - Brussels, 22 January 2018 - REV.1
NOTICE TO STAKEHOLDERS WITHDRAWAL OF THE UNITED KINGDOM AND EU RULES IN THE FIELD OF MEDICAL DEVICES
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