The European Union’s Medical Device Regulations (EU MDR), governing the production and distribution of medical devices in the European Union, has been in effect since 26 May 2021, three years after the revisions were announced. It replaces the EU’s Medical Device Directive (93/42/EEC) and the EU’s Directive on active implantable medical devices (90/385/EEC). These regulations apply to the medical device industry wishing to sell in the European Union and covers:
- Manufacturers
- Importers
- Distributors
- Authorized representatives of medical device companies
EU MDR Requirements
The new regulation’s requirements for the Quality Management System (QMS), as explained in Article 10 (9), are similar to that of EN ISO 13485:2016. They require medical device manufacturers to establish systems, documents, and processes compliant with EU MDR for the continuous monitoring of the safety, efficacy, and efficiency of the medical devices being manufactured and sold in the EU.
The EU MDR, similar to MDD in many aspects, has introduced some new requirements. These include:
- A stricter classification of medical devices
- Improved traceability using a Unique Device Identification (UDI) system
Further, it has also introduced changes in the requirements for the Quality Management System (QMS). Article 10 of EU MDR requires the QMS to include post-market surveillance (PMS) protocols to clinically evaluate and operate a system. A post-market clinical follow-up (PMCF) is also mandated for all the products manufactured by the company.
Companies manufacturing medical devices under Classes IIa, IIb, or III, must get a conformity assessment done by a Notified Body. The Notified Bodies will have to work with expert panels to clear certain high-risk devices. This is especially necessary for Class III devices intended for implantation. Another EU MDR requirement is improved transparency, with information on the medical devices and the tests done being made available in the public domain.
EU MDR regulations have also tightened clinical evaluation requirements, including clinical data collection and the organization of clinical studies. Implantable medical devices and Class III devices will have to undergo clinical trials before being released in the market.
Best Practices for Meeting EU MDR Goals
One of the key purposes of the new EU MDR regulations is to make medical devices used in the European Union safer and more effective. To be able to comply with the EU MDR regulations and meet the safety and performance requirements, medical device manufacturers will need a cloud-based quality management system as traditional, paper-based or hybrid QMS Systems will be ineffective. The need for storage, security, accuracy, and traceability are higher in the new system which legacy-based systems will not be able to handle. Scalability, flexibility, and resource optimization will be challenges that can be managed with a cloud-based quality management system such as ComplianceQuest.
Medical device manufacturers will also be able to drive process optimization, product innovation, and enhanced patient outcomes by implementing a QMS that aligns with the EU MDR framework. Some of the steps to leverage the new regulatory framework include:
- Document Management: This includes creating and maintaining policy documents, standard operating procedures, process related information, labels and technical documentation. All these can be stored in a centralized repository, providing workers easy access for improving their ability to align their tasks to the new statutory requirements.
- Training Management: The employees need to be upskilled to change their approach to certain operations to improve compliance. Implementing a cloud-based solution will enable identifying gaps and creating course materials that can be delivered online to bring the workers up to speed. Tracking and continuous training will also be possible with a cloud-based system, which will help improve compliance faster.
- Traceability: A cloud-based system provides visibility into all processes and access to real-time data. This makes it easy to trace back and identify lapses in case of any nonconformance, identify the root cause and take corrective and preventive action to rectify the issue and prevent future recurrence.
- Product Life Cycle Management: From ideation to obsolescence, the ComplianceQuest quality management system also integrates with the CQ product lifecycle management solution. This helps improve the entire product design, development, manufacturing, marketing, and post-marketing phases to improve process efficiency and increase productivity.
- Automating Workflows: This helps with seamless integration of end-to-end workflows, which further improves process efficiency, manage costs, and free up resources for innovation and enhanced patient outcomes. This also reduces errors due to manual intervention.
- Management Review: The QMS solution provides decision makers with a tower of data to make informed decisions. A solution like CQ with AI infused in it further augments the decision making process and helps improve employee productivity, process efficiency, and product safety and performance.
- Reporting and Rectification: The cloud-based solution empowers employees to report errors and deviations quickly, thereby minimizing the impact and allowing rectification at the earliest. As the root cause investigation and corrective action features are also linked, the findings can be used for mitigating risks. The documents are also easily accessible to demonstrate compliance.
- Lower Cost of Manufacturing: The prevention of errors through risk management and timely action in case of deviations helps reduce wastage and lower the cost of manufacturing. Supplier management is also improved due to access to supplier-related information such as their capabilities, quality processes, etc.
- Innovation: The access to data from across different functional areas, including customer feedback, helps with continuous improvement and innovation. The customer management process is also automated and the data integrated to provide designers and management with feedback that can be used for continuous improvement and innovation.
- Enhanced Patient Outcomes: The improvement in processes, including testing, ensures the product being released in the market meets customer expectations and meets the goals it was designed to fulfill.
Further, ComplianceQuest is aligned with the ISO standards, which accelerates the compliance process and reap the benefits of aligning with the EU MDR Quality Management System requirements.
To know more about how CQ can help with EU MDR compliance, visit: https://www.compliancequest.com/
