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Top 5 Steps for Medical Device Companies for MDR compliance
Preparing for Medical Device Regulation (MDR) certification is a multifaceted process that involves careful planning and comprehensive adherence to regulatory requirements. Here are five main steps to guide manufacturers in preparing for MDR certification:
1. Understand MDR Requirements:
Thoroughly familiarize yourself with the MDR text, understanding its intricacies, and the specific requirements applicable to your medical device.
Identify the classification of your device, applicable conformity assessment routes, and the corresponding technical documentation obligations.
2. Update Technical Documentation:
Review and update your technical documentation to align with MDR requirements.
Ensure that it includes all necessary information related to device design, performance, risk management, clinical evaluation, and post-market surveillance.
Address any gaps in documentation, and pay attention to new requirements introduced by MDR.
3. Engage with Notified Bodies (NBs):
Early engagement with a Notified Body is crucial.
Identify a competent NB that aligns with your device's classification and characteristics.
Establish open communication with the NB, seeking guidance on MDR requirements, conformity assessment procedures, and specific expectations for your device.
4. Implement or Enhance Quality Management System (QMS):
Strengthen your Quality Management System to meet the heightened standards set by MDR.
Implement or enhance processes related to risk management, post-market surveillance, clinical evaluation, and change control.
Ensure that your QMS aligns with the new MDR requirements and is consistently applied throughout the product lifecycle.
5. Plan for Post-Market Surveillance (PMS) and Clinical Evaluation:
Develop a robust plan for post-market surveillance that includes active and systematic data gathering, analysis, and reporting.
Establish procedures for handling complaints, identifying trends, and implementing corrective actions.
Similarly, plan for clinical evaluation, ensuring that it is based on sound scientific principles and includes relevant clinical data.
6. Digitalise your QM and Technical Documentation System:
Seek for systems that allow single items as multiple reusable and traceable information objects, and also provide means for dynamic document creation.
Ensure the system provides real traceability as a core requirement for compliance under MDR, for both process and product documentation.
Select a system that is configurable according to your needs without external consultancy
Check risk management capabilities to allow various methods of risk evaluation to consider various aspects like safety of patients, users, data, and others
Check out MatrixRequirements as example of a combined eQMS and eTD system proven for successful MDR compliant documentation capabilities and customer success stories.
These steps provide a foundational framework for MDR preparation, but it's essential to note that each step involves multiple subtasks and ongoing activities. Regularly review and update your progress to adapt to any changes in regulations or industry standards. Additionally, consider seeking the expertise of regulatory consultants or professionals with experience in MDR compliance to navigate the intricacies of the certification process effectively.