The new EU Medical Device Regulation (MDR) goes into effect in less than six months, leaving little time for medical device manufacturers to bring products into compliance. The new law represents a sweeping overhaul of how Europe regulates medical devices, demanding changes in quality processes across the entire product life cycle.
What are some of the biggest EU MDR compliance problems that companies are running into, and what should they be doing now to ensure a smooth transition?
For most companies, two elements are top of mind: data and documentation.
From new requirements around post-market reporting to traceability and technical documentation, EU MDR is driving a need to analyze and store more information than ever.
To outlast these challenges, companies must find ways to link quality processes and data within the QMS. Creating these essential connections is critical not just to efficiency, but the ability to survive in a post-MDR world.
Preparing for MIR Changes
One striking change in the new EU MDR requirements is the sheer volume of data required. The manufacturer incident report (MIR) form is a key example of the emphasis on data in post-market vigilance and reporting.
The new form for reportable events—with nearly 200 data fields (up from the previous 90) —requires medical device companies to submit detailed information on:
- Event classification: The new MIR form forces manufacturers to choose from a significantly expanded number of International Medical Device Regulators Forum (IMDRF) codes. That includes up to eight categories of causes and multiple sub-codes, with the first one the most relevant.
- Historical data: Companies must provide three years of prior sales and distribution information, as well as the current year, and data on other events associated with the device.
- Risk assessment: EU regulators now require manufacturers to conduct a risk assessment to differentiate between chronic problems versus one-off events.
As if these increased data requirements were not enough, the initial form must be submitted in just two to 15 days. Automated MIR submission via the quality management system (QMS) can help companies cope with these changes, improving the efficiency of complaint tracking while improving data integrity and data quality.
With this approach, the QMS automatically populates data from the complaint and other sources to the MIR form, generating an XML or PDF output for review and submission. Companies can also use decision trees based on business rules to identify where to report the event and route it through the applicable steps to streamline compliance.
Learn about AssurX’s automated process for EU MIR submissions.
Managing New UDI Requirements
After May 26, 2021, all implantable and Class III medical devices sold in the EU must have a unique device identifier (UDI) in line with MDR requirements. The deadlines are as follows for the final attachment to the product (UDI carrier) itself:
|May 26, 2021||Class III Medical Devices and Implantable Devices|
|May 26, 2023||Class IIa and IIb Products|
|May 26, 2025||Class I Products|
|Two Years After the Respective Product Class Date||Reusable Products Where the UDI must be placed on the product itself|
The best place to organize product data from product registration through complaints (including adding the required UDI fields) is a quality management system (QMS). This strategy ensures control at the product level, so products are compliant in the US, EU, and any countries using UDI for patient safety and product traceability in the future.
Updating Technical Documentation and Risk Assessments
EU MDR compliance expectations around technical documentation have changed significantly. For example, the technical documentation now exceeds current requirements in the FDA design history file (DHF) and device master record (DMR). Data requirements are increased throughout the product life cycle. MDR goes even further; the regulation is more prescriptive in terms of risk.
More than just performing a risk assessment, companies must demonstrate that they have reduced risk as far as possible (AFAP), providing evidence that all risks were considered, and controls were implemented. In addition, companies must now:
- Provide information on how they assess and mitigate risks
- Detail how they evaluate whether mitigation is effective
- Predict how patients may misuse products
- Mitigate potential misuse and communicate risks to users
Creating and Compiling Technical Documentation
It is not just the increased scope of technical documentation giving medical device quality managers headaches. MDR requires manufacturers to submit a wide range of product life cycle documents with increased data requirements, including:
- Periodic safety update report (PSUR)
- Periodic evaluation report (PER)
- Summary of safety and clinical performance (SSCP)
- Post-market surveillance (PMS) plans and reports
It’s worth noting that these documents all provide source data for the MIR. That means companies struggling with documentation are likely to have problems with MIR submission, increasing risks, and costs.
The quality management system is crucial to managing technical documentation and life cycle documents, with document management software allowing device manufacturers to:
- Assess gaps in documentation
- Keep document creation and revision moving forward on schedule
- Control revisions and editing permissions
- Route and track approvals
- Prevent versioning errors
Conducting a Product Portfolio Assessment
Given these changes—and the fact that there is no grandfathering of devices—manufacturers must assess their product portfolios to prioritize which devices to continue marketing in the EU.
Some products may not be as profitable after accounting for compliance costs, driving manufacturers to remove them from the market. In other cases, however, companies may not want to give up their hard-won gains in the EU market, especially if they can recoup the revenue in other product areas.
Assessing Gaps in the QMS for EU MDR Compliance
In addition to evaluating their product portfolio, device manufacturers need to make sure their QMS is up to the task of MDR compliance. Specifically, they will want to evaluate processes and identify gaps in:
- Document management
- Complaint tracking
- Corrective and preventive action (CAPA)
- Supplier quality management
- Risk management
Companies with an automated QMS have an advantage in terms of resource efficiency, allowing them to integrate processes, streamline compliance, and automate many regulatory submissions.
Even with the one-year delay in the MDR deadline, the learning curve is steep for many companies. However, the changes also mean more transparency across the entire product life cycle, resulting in better product quality, improved patient safety, global product traceability, and fewer product risks.
How to Meet New EU MDR Requirements for Vigilance and Reporting