The EU Medical Device Regulation (EU MDR) requires more than a few new SOPs. A profound overhaul of the regulatory approach in one of the world’s largest medical device markets, the EU MDR demands new procedures, evidence development, documentation, relationships, reporting, data management, and a reevaluation of legacy portfolios. Senior management should be involved in strategic planning for changes that can significantly affect a company’s business.
The following points must be completed in detail with employee training and Medpoint can help in achieving and meeting the following EU MDR requirements:
- EU MDR provisions and timeline
- Strategic considerations and priorities
- The business impact of compliance
- New clinical evidence requirements
- Changes in postmarket surveillance
- Requirements for economic operators
- Supply chain considerations
- Labeling, IFU, and UDI requirements
- Risk management provisions
- Eudamed database reporting requirements
- Remediation of legacy devices
- Materials of Concern (MOC)
The European Medical Device Regulation (EU MDR) ensures high standards of quality and safety for medical devices being produced in or supplied into Europe. EU MDR had a fundamental revision in 2017 to better identify medical devices products and improve transparency through standard data, technological advances and the establishment of an EU database (Eudamed). Similar to the FDA’s UDI, EU MDR will establish a robust, transparent, predictable and sustainable regulatory framework for medical devices to ensure a high level of health and safety whilst supporting innovation. Medpoint can help to achieve these goals.
EU MDR is relevant to any organization producing or supplying medical device products to Europe. Medpoint can help your organization every step of the way or can cater to your unique needs in this area. Our expert consultants can help you navigate the process from start to finish. To learn more, contact us today at hello@medpoint.com.
