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Introduction: scope and contents  This document aims to provide guidance on different aspects related to standards in the medical devices sector in support of the requirements laid down in the applicable EU legislation, taking into account its specificities. The contents of this document:  are not intended to be exhaustive, and must be read and used within the legal and guidance framework on EU ..

This is the third in our series of regulatory updates on the EU Artificial Intelligence Act (AIA). Since more than one month has passed since the law’s approval, we are providing this article ahead of the AIA’s publication in the Official Journal of European Union (OJEU). BackgroundOn May 21 2024, the EU AIA was approved and given the final green light by the EU Council. The AIA establishes requ..

The level of clinical evidence that is required to place medical devices on the market has been increased by the MDR, including an increased need for pre-market clinical investigations for certain higher risk devices to verify their safety and clinical performance. These increased clinical evidence requirements present a challenge for devices specifically intended for use in rare diseases/condit..

Introduction and scope This document aims to provide guidance to the authorities responsible for notified bodies (hereafter, the Designating Authorities) and joint assessment teams (JATs) when conducting: − assessments of conformity assessments bodies (CABs) that apply for designation as a notified body (NB) in the field of medical devices and/or in vitro diagnostic medical devices,− extensions ..

IntroductionThe aim of this Device Specific Vigilance Guidance (DSVG) is to harmonise vigilance reporting and provide guidance for manufacturers of Urogynaecological Surgical Mesh Implants used for Pelvic Organ Prolapse repair and Stress Urinary Incontinence. It provides further clarification for vigilance reporting of Urogynaecological Surgical Mesh Implants used for Pelvic Organ Prolapse repai..

A recent round of inspections by the Dutch Health and Youth Inspectorate (IGJ) has found that more than one-third of European Authorized Representatives (ARs) operating in the Netherlands have yet to meet all requirements applicable under the European Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR). European Authorized Representatives under supervisionE..

On April 15, 2024, the Medical Device Coordination Group (MDCG) released a new guidance document; MDCG 2024-4 Safety Reporting in Clinical Performance Studies of in Vitro Diagnostic (IVD) under the EU IVD Regulation (2017/746, IVDR). The guidance provides an in-depth look at safety reporting requirements for IVD performance studies under the IVDR. It introduces a tabular performance study Summar..

▶ Preliminary re-assessment review (PRAR) form template (MDR) - MDCG 2024-6▶ Preliminary assessment review (PAR) form template (MDR) - MDCG 2024-7▶ Preliminary assessment review (PAR) form template (IVDR) - MDCG 2024-8▶ Preliminary re-assessment review (PRAR) form template (IVDR) - MDCG 2024-9

The European Commission (EC) published its second annual overview concerning medical devices subject to the Clinical Evaluation Consultation Procedure (CECP) (Article 54) of the Medical Devices Regulation (MDR) (EU) 2017/745. This is an update to the first CECP report (April 2021-June 2022). The current report summarizes activities of expert panels to the CECP from July 2022 through June 2023. C..

Regulation (EU) 2017/746 on in vitro diagnostic medical devices (the IVDR) requires that the manufacturer shall draw up a summary of safety and performance (SSP) for class C and D devices, other than devices for performance studies. The SSP shall be validated by a notified body (NB) and made available to the public via the European database on medical devices (Eudamed). Text elements in italic i..