The year 2017 was distinguished by change—the U.S. inaugurated its 45th president, the U.K. presented the start of Article 50, and the recovery of global growth from the Great Recession rebounded. Another significant event and change was the introduction of two regulations in Europe—the new Medical Device Regulation (MDR) and the In Vitro Diagnostic Medical Device Regulation (IVDR).
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Technician Repairing an Operating Microscope
The goal was to replace decades-old legislation with regulations that are more in line with the latest technological advances and medical science while creating a more transparent regulatory framework that helps improve patient safety. The regulations also provide stricter oversight in many areas as compared to the European Union’s (EU’s) previous Active Implantable Medical Device Directive (AIMDD) and Medical Device Directive (MDD) and In Vitro Diagnostic Medical Device Directive (IVDD).
In general, the objectives of EU MDR and IVDR are to improve traceability, significantly boost post-sale surveillance during the lifecycle of the product and increase the safety of medical devices.
The new regulations require manufacturers to revisit their quality management system (QMS) and update core processes. This can be daunting without the proper preparation and systems in place to effectively manage product information and keep everyone on the same page.
Here, we review some key changes under the MDR and IVDR that have the greatest impact on manufacturers and discuss how a QMS can help navigate these changes and streamline compliance.
Notworthy changes under MDR and IVDR
Notified Bodies
Notified Bodies have taken on more responsibility in enforcing regulations through annual on-site assessments as well as unannounced audits of manufacturing processes, subcontractors, and suppliers. Their focus is on evaluating the manufacturer’s QMS and reviewing technical documentation for the different classes of devices.
Device Classifications
Some medical devices (e.g., active implantable devices) have been reclassified to higher risk categories under the new MDR. In turn, in vitro diagnostic devices have been assigned an entirely new risk-based classification structure (i.e., Class A, B, C, and D) under the IVDR. These reclassifications may warrant collecting additional clinical data or implementing new clinical studies to validate the device’s performance.
Technical File
Unlike previous EU directives, the MDR and IVDR outline more specific requirements for technical file documentation such as product design and supplier information, product verification and validation, pre-clinical and clinical data, and post-market surveillance (PMS) plan and reports.
Clinical/Performance Evaluations
More scrutiny is placed on manufacturers to proactively collect and evaluate clinical data throughout the product lifecycle. This involves planning, conducting, and documenting a clinical/performance evaluation. The evaluations must be thorough and consider both favourable and unfavourable data. The extent to which data is collected should be in line with the nature, classification, intended purpose, and risk of the device as well as safety and performance claims.
Post-Market Surveillance
Post-market surveillance (PMS), which aims to continuously monitor a device’s quality, performance, and safety throughout its entire lifecycle, is given more importance in the new MDR/IVDR. PMS gives manufacturers the ability to swiftly spot problems with the device’s design, manufacturing, or application, ultimately improving patient safety.
Quality Management System (QMS)
To market and sell medical devices in the EU, manufacturers must set up and maintain a QMS. Under the MDR and IVDR, several new QMS requirements have been included. These new specifications apply to both newly released devices and those already on the market.
Device certification will be revoked for failure to install a strong QMS, making it illegal to sell the device in nations that require certifications.
Here are some key QMS requirements under the new MDR/IDVR regulations:
- Defined strategy for regulatory compliance, including compliance with conformity assessment procedures and procedures for the management of device modifications
- Designated “person responsible for regulatory compliance"
- System for identifying all applicable general safety and performance requirements
- Product realisation—planning, design, development, production, and service provision
- Management of resources (i.e., infrastructure and equipment) and supply chain
- Development of a risk management plan
- System for serious incidents and corrective action reporting
EU MDR vs EU IVDR comparison
MDR/IVDR Checklist Preparation:
- Establish an MDR/IVDR transition team.
- Confirm medical device classification under MDR/IVDR.
- Contact notified body to confirm scope of designation and timeline for assessment.
- Develop MDR/IVDR transition plan, budget, and timeline.
- Designate “person responsible for regulatory compliance.”
- Develop a risk management plan.
- Prepare plans for clinical evaluation, post-market clinical/performance follow-up (PMCF/PMPF), and post-market surveillance.
- Update QMS, technical file, and device labelling per MDR/IVDR requirements.
- Conduct company-wide training on new MDR/IVDR and QMS.
- Conduct internal audit to verify that all requirements are met.
A regulatory framework to ensure safety and performance of devices—are you ready?
Implementing the MDR/IVDR poses various challenges, but it also presents opportunities for businesses to streamline their supply chains, rationalize and optimize their product portfolio, and implement more robust design and QMS procedures to ensure safer products and ongoing sales in the EU.
How Arena can help
You might find it challenging to manage as you begin to review your present quality processes and gather all the essential product data for MDR/IVDR compliance, particularly if you are using manual, paper-based, or siloed systems.
By connecting all of your product information and quality processes in one central platform, a product centric QMS like Arena’s can make compliance easier.
Arena QMS manages linked relationships between device master records (DMRs), design history files (DHFs), bills of materials (BOMs), approved manufacturer/vendor lists (AMLs/AVLs), technical documentation, product history, and any changes or quality issues, in contrast to traditional document-based systems that are unable to manage the entire product record.
With Arena, your team can concentrate on producing safe and effective products and spend less time maintaining documents. To learn more about Arena QMS, visit arenasolutions.com.
