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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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EC MDCG: Guidance on Clinical Evaluation of Orphan Medical Devices
The European Commission Medical Device Coordination Group (MDCG) has issued a new guidance "Clinical Evaluation of Orphan Medical...
Sharan Murugan
Jun 29, 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
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Gilead: First Regulatory Approval of HIV Sunlenca® (Lenacapavir) the Only Twice-Yearly HIV Treatment
On 22-August-2022, Sunlenca (lenacapavir) is an injectable HIV medication developed by Gilead Sciences that has been approved to market...
Sharan Murugan
Aug 24, 20221 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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