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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...

Jul 52 min read

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...

May 312 min read

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...

Apr 202 min read

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...

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...

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...

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...

Aug 25, 20211 min read

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...

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...