MDCG Guidance Clarifies IVDR Product Classification and Scope
Despite over a year having passed since publication of Version 3 of the Manual on borderline and…
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MDCG Guidance on CAPA Plan Assessment for Notified Bodies
The MDCG (Medical Device Coordination Group) has released a guidance document titled “Corrective and Preventive Action (CAPA)…
EMA Launches Pilot Program for Orphan Medical Devices in EU
The European Medicines Agency (EMA) has launched a pilot program aimed at supporting manufacturers of high-risk medical…
IGJ Report Urges Medical Device Manufacturers to Prioritize PMS
The IGJ, or the National Competent Authority of the Netherlands, published a report as a call to manufacturers to focus…
EU-Swiss Medtech Industry Supports MRA Update Negotiations
A joint statement by Swiss Medtech, SVDI, and MedTech Europe highlights the industry’s support for the ongoing EU-Switzerland negotiations…
FDA Proposed Reclassification of HBV Diagnostic Devices
On September 25, 2024, the FDA published a proposed change to the classification rules for several…
MHRA Guidance on Clinical Investigations for Medical Devices
The Medicines and Healthcare products Regulatory Agency (MHRA) has issued an updated guidance for notifying clinical investigations involving medical…
Class D IVD Certification: Updated Guidance
The MDCG 2021-4 rev.1 document, updated in September 2024, offers essential guidance on Class D IVD Certification,…
New EU Rules on Substances of Human Origin (SoHO)
The European Union has introduced new standards to enhance the safety and quality of substances of human origin (SoHO), such…
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