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Medical Devices - Sector - Latest updates (157)
RSSInformation session on MDR/IVDR for international regulators – 4 July 2024
MDCG 2020-16 Rev.3 - Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746 - July 2024
Update - MDCG 2021-5 Rev.1 - Guidance on standardisation for medical devices - July 2024
New guidance on the clinical evaluation of orphan medical devices published
MDCG 2024-10 - Clinical evaluation of orphan medical devices - June 2024
Update - SCHEER guidelines phthalates
Update - MDCG 2022-13 Rev.1 - Designation, re-assessment and notification of conformity assessment bodies and notified bodies - June 2024
MDCG 2024-1-5 - Urogynaecological Surgical Mesh Implants used for Pelvic Organ Prolapse repair and Stress Urinary Incontinence (June 2024)
Revision 2 of MDCG 2022-4 on MDR Appropriate surveillance
MDCG 2024-6, 7, 8 and 9 - Preliminary (re-)assessment review form templates
MDCG 2024-5 - Guidance on the Investigator’s Brochure content - April 2024
Update - MDCG 2022-9 rev.1 - Summary of safety and performance template - April 2024
MDCG 2024-4 - Safety reporting in performance studies of in vitro diagnostic medical devices under Regulation (EU) 2017/746 - April 2024
A Study and dashboard on reprocessing and reuse of single-use-devices in the EU
Overview of language requirements for manufacturers of medical devices
MDCG 2024-3 - Guidance on content of the Clinical Investigation Plan for clinical investigations of medical devices (March 2024)
Expression of interest open – Possible second call for EU reference laboratories for high-risk in vitro diagnostic medical devices
MDCG 2024-1 - Device Specific Vigilance Guidance (DSVG) Template - January 2024
MDCG 2024-2 - Procedures for the updates of the EMDN - February 2024
Commission proposes to extend transition periods for certain IVDs, gradual roll-out of Eudamed and an information obligation in case of interruption of supply