New and revised guidance documents available in Europe

The following new guidance documents for device manufacturers placing devices on the European market have been published in recent weeks:

MDCG 2024-1-5: Urogynaecological Surgical Mesh Implants used for Pelvic Organ Prolapse repair and Stress Urinary Incontinence
MDCG 2022-13 Rev.1: Designation, re-assessment and notification of conformity assessment bodies and notified bodies
MDCG 2024-10: Clinical evaluation of orphan medical devices
MDCG 2021-5 Rev. 1: Guidance on standardisation for medical devices
SCHEER: Update of the guidelines on the benefit-risk assessment of the presence of phthalates in certain medical devices covering phthalates which are carcinogenic, mutagenic, toxic to reproduction (CMR) or have endocrine-disrupting (ED) properties