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Sharan Murugan
Nov 302 min read
MDCG Guidance: Implementation of the Master UDI-DI Solution for Contact Lenses
In November 2024, the Medical Device Coordination Group (MDCG) released " MDCG 2024-14 - Guidance on the implementation of the Master...
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Sharan Murugan
Jul 102 min read
WHO: MeDevIS Platform and EU MDCG Guidance: Classification Rules for IVDs
WHO MeDevIS platform: The World Health Organization (WHO) has established the first global open access clearing house for medical device...
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Sharan Murugan
Jul 52 min read
MDCG Med Dev Guidance: Standardisation for Medical Devices
The Medical Device Coordination Group recently updated the guidance"Standardisation for Medical Devices" include points on topics...
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Sharan Murugan
May 312 min read
EU MDCG: Revised Device Surveillance Guidance
Medical Device Coordination Group (MDCG) released a second revision to its Surveillance Guidance for Medical Devices, aligning it with EU...
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Sharan Murugan
Apr 202 min read
MDCG Guidance: In-Vitro Diagnostic Medical Device Safety Reporting
The European Commission’s Medical Device Coordination Group (MDCG) released updated guidance "Safety reporting in performance studies of...
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Sharan Murugan
May 13, 20231 min read
EC MDCG: Med Dev Guidance on Significant Changes regarding the Transitional Provision MDR
The European Commission’s Medical Device Coordination Group (MDCG) released updated guidance "Guidance on significant changes regarding...
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Sharan Murugan
Feb 14, 20231 min read
EC-Med Dev.CG - Guidance on Classification Rules for In-vitro Diagnostic Medical Devices
The Medical Device Coordination Group (MDCG) released an updated guidance on "Classification Rules for In-vitro Diagnostic Medical...
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Sharan Murugan
May 24, 20221 min read
Q&A Guidance on Unique Device Identification system - Medical Device Coordination Group
On 20 May 2022 MDCG, the Medical Device Coordination Group of the European Commission has released a question and answer guide for the...
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Sharan Murugan
Aug 25, 20211 min read
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...
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Sharan Murugan
Aug 6, 20211 min read
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...
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