Legacy device manufacturer's urgency for MDR - Key Steps for last minute action
Legacy device manufacturers are currently facing a critical juncture as the last call for transition under the Medical Device Regulation (MDR) approaches within the next five months. While products already in the market can continue to be sold during the transition period until December 31, 2027, or December 31, 2028 (for devices with a valid CE mark expiring until May 26, 2024, or custom-made devices), manufacturers must ensure eligibility for this extended period. To achieve this, a written agreement with a notified body and a valid application for MDR conformity assessment must be in place by May 26, 2024, as detailed in EU publications.
This article explores the challenges faced by legacy device manufacturers due to the extended scope of the MDR transition phase and outlines steps to prepare for a successful MDR application.
Challenges for Legacy Device Manufacturers
Limited Transition Period Benefits
The extension of the MDR transition phase primarily grants Notified Bodies (NBs) more time to evaluate applications for conformity assessment for legacy devices. To benefit from this transition period, manufacturers must submit an application for MDR conformity assessment and receive a confirmation ("written agreement") from the notified body.
It is essential that this application already is acceptable from the Notified Body - basically this requires that this application documents the product and applied processes according to MDR requirements at least demonstrated with the checklists of the Notified Body.
Technical Documentation Modification
Manufacturers must sustainably modify their technical product documentation and Quality Management Systems (QMS) to align with MDR requirements. This involves thorough adjustments to demonstrate compliance with the new regulations.
Especially clinical data and ongoing evaluation of market performance will have to be included and demonstrated.
Improval of risk management for all product lifecycle phases, and traceability to the clinical evaluation and post market surveillance activities is crucial for the MDR compliant documentation.
Unawareness of Transition Duration
Many manufacturers are unaware of the time required for a smooth transition to the new MDR regulations. Lack of early planning leaves them without a valid certificate for products that have been on the market for decades, posing a risk to their ability to sell within the EU after May 26, 2024.
This leads to the need for either instant action, or adopt business plans to allow for a complete new application cycle for the legacy products. However, products that have already been sold can still be used even after their CE mark became invalid, as long as the product lifetime allows.
Potential Market Reduction
Predictions suggest that up to 30% of medical devices could disappear from the market due to non-compliance with the EU MDR. Manufacturers who fail to adapt in time may face market reduction and potential financial implications. In here lay chances for innovative products to fill the gap, but there is a potential that certain products will be missed.
Legacy device manufacturers should prioritize their product strategy also regarding the risk for patients when the product is not available anymore.
Safety and State-of-the-Art Demonstrations
Devices successfully used for decades may now need to prove their safety and compliance with current standards. Manufacturers may struggle to demonstrate the state of the art of their products, especially if they have not actively collected and evaluated user feedback.
Manufacturers should get in close contact with their users to gather current experience and make them base of thourough risk management of the current state, and future monitoring activities to set up post market surveillance plans. Experts in medical writing and clinical evaluation will be necessary to achieve sufficient evidence regarding state-of-the-art and safety of the product in use.
Steps for Legacy Device Manufacturers to Prepare for MDR
Risk Class Determination and Conformity Pathway Selection
Determine the risk class of devices according to MDR and choose the appropriate conformity pathway. Conduct a gap analysis of legal requirements based on the selected pathway.
If the risk class changed to a higher level, even design changes might be necessary to achieve risk mitigation accordingly.
A re-documentation from scratch might be an alternative to extensive change of existing documentation.
clinical evaluation needs to be re-started together with the gap analysis to include state-of-the-art consideration, and allow time for clinical data research and evaluation.
Engage with Notified Bodies
Initiate communication with the notified body to express the intention to submit an application soon. Keep them informed of the progress in preparing for MDR compliance.
Expand Quality Management Systems (QMS)
Expand QMS to include processes required by MDR. Clearly articulate how clinical evaluation and market surveillance are conducted to ensure a comprehensive understanding of device performance.
Since almost all other processes may be affected from the MDR needs for a more thorough and safety oriented product lifecycle management and documentation, this may be a chance to revise the QMS as such.
Take exchange of QMS tooling into consideration - digitalised QM systems will support correct implementation and monitoring of QA activities, and support the massive changes required from the MDR transition.
Transitioning of your QMS to a more up-to-date technology will be a positive aspect for auditors and demonstrate manufacturers dedication to fulfil the increased regulatory requirements.
Schedule QMS Audit Under MDR
If not done already, schedule a QMS audit under the MDR. Showcase progress in preparing the QMS and device documentation to the notified body during the audit.
Have external consulting organisations to conduct pre-audits to get insights to gaps and how to overcome them.
Adapt Product Documentation to MDR
Modify product documentation to align with MDR requirements and the chosen conformity pathway. Ensure that all aspects, including design, manufacturing, performance, and safety considerations, are adequately addressed. This will involve updating existing documents and creating new ones as needed.
Focus on clear definition and identification of requirements, specifications, and test, and their traceability as base for enhanced risk analysis including use errors and handling procedures.
Tools that convert paper-based documentation into structured data items can facilitate the creation of new documentation, risk analysis, and traceability, helping to ensure compliance with MDR.
Digitize clinical validation processes, Post-Market Surveillance (PMS), and Post-Market Clinical Follow-up (PMCF). Ensure that the clinical data collected supports the safety and performance claims of the device throughout its entire lifecycle.
If needed, seek external expertise, including consultants or regulatory affairs professionals, to provide guidance on MDR compliance and documentation adoption. External experts can offer valuable insights and help expedite the adaptation process.
Generate new product documentation and, at the very least, draft plans for clinical evaluation. Submit these documents to the notified body for assessment.
utilize checklists for MDR requirements and the general safety and performance requirements to map you document content
using digital tools that keep traces between regulatory requirements, notified body checklists and manufacturers documentation will extremely support the process, especially when built upon a document management system that is able to manage and evaluate these relations.
Utilize Digital Tools for Documentation Analysis
Employ digital tools and skilled experts to analyze existing documents.
Tools that convert paper-based documentation into structured data items facilitate the creation of new documentation, risk analysis, and traceability.
Implementation of AI based systems can be of great value for this task.
Collaborate with Matrix Requirements
Leverage solutions like MatrixRequirements to streamline the preparation of documentation for MDR compliance and adopt the QMS system and processes.
MatrixRequirements can help automate the creation of new documents, risk analysis, and traceability, easing the burden on manufacturers.
MatrixRequirements has an eQMS and a eTD solution that allow full traceability from standards via process documentation through document templates to process implementation and product lifecycle information like requirements, specifications, tests, risk analysis and allows evaluations of product safety by various aspects and process effectiveness. Creation of required documentation like the technical documentation, clinical evaluation report, Post-Market Surveillance Plan, Post-Market Follow-Up Plan, Summary of Safety and Clinical Performance, and the Quality Management System Documentation is well supported using the item-based approach for information management of Matrix Requirements.
As the last call for transition under MDR approaches, legacy device manufacturers must act promptly to secure eligibility for the extended transition period. Adapting to the stricter clinical evidence requirements and other regulatory changes demands careful planning and comprehensive efforts. By following the outlined steps and utilizing digital tools, manufacturers can enhance their preparedness for MDR compliance and continue to market their legacy devices within the EU. The team at MatrixRequirements is ready to provide support throughout this crucial process.