Glossary
EU MDR: The European Medical Device Regulation
What is the EU Medical Device Regulation (MDR)?
The EU Medical Device Regulation (MDR), officially known as Regulation (EU) 2017/745, is a comprehensive regulatory framework established to ensure the safety and effectiveness of medical devices in the European Union. It replaced the previous Medical Devices Directive (MDD) and came into force on May 26, 2021.
What are the main objectives of the EU MDR?
The primary objectives of the EU MDR are to enhance patient safety, improve the quality and reliability of medical devices, ensure transparency in the market, and strengthen post-market surveillance and vigilance regarding devices in use.
What are the key changes introduced by the EU MDR?
Key changes include stricter requirements for clinical evaluations, enhanced scrutiny of notified bodies, increased transparency in device information, and more rigorous post-market surveillance obligations. Manufacturers must also provide detailed technical documentation and ensure compliance with new labelling requirements.
What are the consequences of non-compliance with the EU MDR?
Non-compliance with the EU MDR can lead to significant penalties, including fines, withdrawal of products from the market, and damage to a company’s reputation. It may also result in legal actions and increased scrutiny from regulatory authorities.
