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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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European Commission: Health Technology Assessment -Guidance on Outcomes for Joint Clinical Assessments and Reporting Requirements
The European Commission has recently published two new guidance documents on Health Technology Assessment (HTA), dated June 13, 2024....
Sharan Murugan
Jun 23, 20242 min read
21 views
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EC Guidance: Transition from Clinical Trials Directive to the Clinical Trials Regulation
The European Commission (EC) has long recognized the importance of streamlining and harmonizing the regulation of clinical trials across...
Sharan Murugan
Jul 24, 20232 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
79 views
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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
11 views
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UK MHRA: Guidance on EC Decision Reliance Procedure Extended till 31 Dec, 2023 & Nitrosamine Risk
On 18th November 2022 the UK's Medicines and Healthcare products Regulatory Agency released its updated guidance on the "European...
Sharan Murugan
Nov 19, 20221 min read
27 views
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EC MDCG Guidance on Legacy Medical Devices, Repackaging Data
The European Commission’s Medical Device Coordination Group (MDCG) released a document detailing how the newly implemented Medical Device...
Sharan Murugan
Nov 7, 20211 min read
16 views
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European Commission’s MCGD New Guidance on Classification of Medical Devices
European Commission’s Medical Devices Coordinating Group (MDCG) on 04-October-2021 issued guidance to support manufacturers classify...
Sharan Murugan
Oct 8, 20211 min read
16 views
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European Commission (EC) updated guide on Good Lay Summary Practice
The European Commission (EC) on 04-October-2021 has put out recommendations on finest practices for preparation, translation and...
Sharan Murugan
Oct 7, 20211 min read
143 views
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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
4 views
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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
47 views
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