‘CE marking of conformity’ or ‘CE marking’ means a marking by which a manufacturer indicates that a device is in conformity with the applicable requirements set out in this Regulation and other applicable Union harmonisation legislation providing for its affixing;

Jul 10, 2024 · Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) establish that Notified… Latest updates News announcement

They are regulated at EU Member State level, but the European Medicines Agency (EMA) is involved in the regulatory process. Manufacturers can place a CE (Conformité Européenne) mark on a medical device once it has passed a conformity assessment.

MDR Guidances and Tools. Download the free MDR Gap Analysis Tools. Check latest MDCG. Check guidance documents from EU and Notified Bodies. Review the list of Meddev Guidances. Reach out for support. Learn more about UDI/EUDAMED. Check …

Commercializing medical devices in the European Union (EU) requires a CE marking demonstrating compliance with the medical device regulations. The CE marking indicates that the legal manufacturer has assessed the device and that it meets the General Safety and Performance Requirements under the MDR 2017/745.

Are you looking for the latest consolidated text of the EU MDR? Click here. Listed below are some of the most recent publications supporting the implementation of the EU MDR. Update of MDCG 2019-6 rev.5 - Questions and answers: Requirements relating to notified bodies.

Do you know the requirements and your responsibilities for medical device vigilance reporting? What are the requirements for vigilance reporting and post-market surveillance? What does the future look like for the medical devices industry?

Dec 16, 2024 · Manufacturers are encouraged to draw up an action plan and prepare the MDR. Useful Information. Factsheet for Manufacturers of Medical Devices; Implementation Model for Medical Devices Regulation - Step by Step Guide

Apr 14, 2023 · Get your CE marking under the new requirements of EU MDR for the commercialization of your medical device in the European marketplace in 5 steps.

Oct 31, 2023 · Explore the crucial steps for obtaining CE approval for your medical device under MDR. Learn more about the key aspects of conformity assessment tailored to each device class.