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MDCG Med Dev: Guidance on Classification Rules for In-Vitro Diagnostic Medical Devices (IVDs)
The Medical Device Coordination Group (MDCG)Â has released the 2020-16 rev.4Â guidance document, " Guidance on Classification Rules for in...
Sharan Murugan
5 days ago2 min read
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MDCG Guidance: Implementation of the Master UDI-DI Solution for Contact Lenses
In November 2024, the Medical Device Coordination Group (MDCG) Â released " MDCG 2024-14 - Guidance on the implementation of the Master...
Sharan Murugan
Nov 30, 20242 min read
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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...
Sharan Murugan
Jul 10, 20242 min read
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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...
Sharan Murugan
Jul 6, 20242 min read
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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...
Sharan Murugan
May 31, 20242 min read
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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...
Sharan Murugan
Apr 20, 20242 min read
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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...
Sharan Murugan
May 13, 20231 min read
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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...
Sharan Murugan
Feb 14, 20231 min read
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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...
Sharan Murugan
May 24, 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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