EU MDR Readiness FAQ
Q: What steps should be taken to prepare for compliance with EU MDR?
A:
- Assess your situation.
- Formulate a project plan.
- Review your Quality Management System (QMS).
- Review alignment with Technical Document structure in Annex II and III.
- Consider needed validation and standards.
- Evaluate product compliance.
- Formulate an action plan.
Q: How do you formulate a project plan?
A: Conduct a gap assessment checklist to identify areas needing attention and then formulate them into a project plan. If you’re unsure where to start or lacking capacity, consider partnering with a consultancy to conduct a comprehensive gap assessment and provide necessary support and materials for the project team. Recognize that transitioning from MDD to MDR can be complex and time-consuming. Establish a project plan early and allocate sufficient resources. Seek advice or assistance as needed to navigate the transition effectively.
Q: How do you review your QMS?
A: Ensure compliance with ISO 13485:2016 by reviewing key elements such as Management Controls, Design and Development, Corrective and Preventative Actions (CAPA), and Clinical Evaluation. Consider streamlining operations for continuous clinical evaluation during both design and post-market surveillance phases. Your QMS should also facilitate identification and management of key risks associated with EU MDR compliance.
Q: How do you review Technical Documentation structure for EU MDR (or IVDR)?
A: Confirm alignment with specified Technical Documentation structures in Annex II and III of the MDR (or IVDR) to meet conformance requirements. Ensure Notified Bodies can enforce alignment to these structures, and initiate transition plans for legacy products.
Q: How do you know which validation and standards are needed?
A: Utilize common and harmonized standards, ensuring compliance with the latest versions. Incorporate validated industry methodologies into Quality Management Systems and Technical Documentation updates. Plan for external testing where necessary, considering timelines and resource allocation.
Q: How do you evaluate product compliance?
A: Understand the new General Safety and Performance Requirements (GSPR) and convert existing Essential Requirements into GSPRs. Conduct a side-by-side comparison of MDD and MDR requirements to identify deficiencies and ensure compliance during design and development phases.
Q: How do you formulate an action plan?
A: Develop an action plan encompassing alignment with Technical Documentation structures, QMS updates, reclassification needs, third-party lab protocols, regulatory planning, post-market surveillance, and audit revisions. Translate gaps into deliverable items with clear timelines, responsibilities, and budget considerations. Obtain top management support for project plan approval and interdepartmental buy-in.
Q: Do you need to conduct a literature search for EU MDR?
A: Ensure adequate clinical evidence to demonstrate compliance with essential safety and performance requirements by conducting systematic literature searches as part of Clinical Evaluation processes.
