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Sharan Murugan
Jul 10, 20242 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
Jun 23, 20242 min read
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....
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Sharan Murugan
Jul 24, 20232 min read
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...
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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
Nov 19, 20221 min read
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...
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Sharan Murugan
Nov 7, 20211 min read
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...
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Sharan Murugan
Oct 8, 20211 min read
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...
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Sharan Murugan
Oct 7, 20211 min read
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...
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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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Sharan Murugan
Jul 14, 20211 min read
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...
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