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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...

Jun 282 min read

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...

Jun 232 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....

Aug 24, 20221 min read

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...

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...