European Union

The Medical Device Regulation (MDR) is a comprehensive regulatory framework established by the European Union (EU) to ensure the safety, quality, and performance of medical devices. It replaces the previous Medical Device Directive (MDD) and Active Implantable Medical Device Directive (AIMDD), aiming to enhance patient safety and streamline regulatory processes.

The primary objectives of the MDR include:

• Strengthening patient safety through stricter pre-market and post-market surveillance.
• Enhancing transparency and traceability of medical devices throughout their lifecycle.
• Promoting innovation and technological advancements while ensuring their safe and effective use.
• Improving coordination and collaboration among EU member states and regulatory authorities.

The MDR impacts various stakeholders involved in the medical device industry, including:

• Manufacturers of medical devices, including those producing software intended for medical purposes.
• Authorized representatives acting on behalf of manufacturers based outside the EU.
• Importers responsible for bringing medical devices into the EU market.
• Distributors involved in the supply chain of medical devices within the EU.

To ensure compliance with the MDR, companies should:

• Conduct a thorough review of their product portfolio to determine the classification and applicable requirements.
• Establish robust quality management systems (QMS) to meet the MDR's stringent regulatory standards.
• Compile comprehensive technical documentation, including clinical evaluation reports and risk management files.
• Implement post-market surveillance processes to monitor the safety and performance of medical devices.
• Collaborate closely with notified bodies and regulatory authorities to obtain necessary certifications.