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EMA Guidance for Applicants seeking Scientific Advice and Protocol Assistance
This guidance document addresses a number of questions that users of the scientific advice or protocol assistance procedures may have and...
Sharan Murugan
Jan 16, 20221 min read
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MDCG Guidance for NBs, importers, & distributors: QMS certification for relabelling & repackaging
The MDCG Guidance provides an overview of activities, requirements, auditing, surveillance and changes and minimum content of the...
Sharan Murugan
Aug 25, 20211 min read
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MDCG Guidance on UDI Integration -European Comission
Medical Device Coordination Group Document (MDCG) published a guidance (MDCG 2021-19) note integration providing recommendations on how...
Sharan Murugan
Aug 6, 20211 min read
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MDCG 2021-14 - Explanatory note on IVDR codes - European Commission
European Commission’s Medical Device Coordination Group (MDCG) released a new document on 13-July-2021, detailing the use of codes under...
Sharan Murugan
Jul 14, 20211 min read
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Five Drugs as Preferred for COVID-19 Therapeutics - listed by EMA
The European Medicines Agency (EMA) has issued a list of five preferred therapeutics for COVID-19 patients, including four monoclonal...
Sharan Murugan
Jul 1, 20211 min read
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MDCG offers Guidance on Clinical Investigations – Europe
The European Commission’s Medical Device Coordination Group (MDCG) last week issued guidance providing a set of templates that will be...
Sharan Murugan
May 28, 20211 min read
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EU IDMP Implementation Guide - version 2.0
EMA published the current version, version 2.0 (EU IG v2.0), in February 2021. It mainly serves to support the European medicines...
Sharan Murugan
May 3, 20212 min read
674 views
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