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[EU, MDR] Update - MDCG 2022-13 Rev.1 - Designation, re-assessment and notification of conformity assessment bodies and notified bodies - June 2024

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..

Safety reporting in performance studies of in vitro diagnostic medical devices (IVDs) shall be performed in line with the requirements of Article 76(2) of Regulation (EU) 2017/746 – In Vitro Diagnostic Medical Device Regulation (IVDR): The sponsor shall report without delay to all Member States in which a performance study is being conducted all of the following by means of the electronic system..

March in Europe The European Commission (EC) updated several medical device safety regulation documents in March 2024. This includes additional standards harmonized with the Medical Devices Regulation (2017/745, MDR) and In Vitro Diagnostics Devices Regulation (2017/746, IVDR) and published in the Official Journal of European Union (OJEU). It also includes an updated study on Notified Body appli..

Description The Commission and Member States have created MDR and IVDR tables. These tables aim to help manufacturers of medical devices and in vitro diagnostic medical devices, particularly small and medium-sized ones, understand the language requirements for the information and instructions that accompany a device in a specific country. The tables provide an overview of the language requiremen..