The Impact of Post-EU MDR Compliance on Medical Device Manufacturers

The extended EU MDR transition deadline is just around the corner for manufacturers looking to sell their medical devices in the European Economic Area (EAA). Effective May 26, 2024, companies must submit a conformity assessment application and implement a quality management system (QMS) according to the latest EU MDR guidelines to obtain their product certification.

Here, we review the key requirements for maintaining product certifications under the EU MDR. We also explore some of the post compliance hurdles facing manufacturers and highlight how an enterprise QMS solution can help.

NAVIGATING A NOT SO SMOOTH EU MDR TRANSITION

Since the EU MDR’s introduction in 2017, organizations have had to navigate a slew of changes which significantly impact how they bring new products to market. They include:

• Increased supervision over notified bodies
• More focus on the entire product lifecycle as opposed to just the pre-approval stage
• Four new medical device classification rules and reclassification of some medical devices to higher risk categories
• Inclusion of a unique device identifier (UDI) on product labeling
• Expanded technical file documentation
• Greater emphasis on clinical data and post-market surveillance
• Registration with the European Database for Medical Devices (EUDAMED)

Despite the extended transition deadline, there are still some wrinkles to iron out. For instance, EUDAMED data requirements are not yet finalized. The European Commission developed EUDAMED to help improve transparency of medical device information across the EU market. As of today, the modules pertaining to clinical data, serious incidence reports, and post-market surveillance (i.e., modules 4-6) are still in development. Additionally, there is a shortage of accredited notified bodies which may lengthen manufacturers’ certification timelines.

Regardless of these setbacks, manufacturers should start planning how they will maintain compliance evidence after completing the certification process.

POST CERTIFICATION REQUIREMENTS UNDER THE EU MDR

Upon receiving their CE certification, medical device manufacturers must maintain extensive post-market documentation to demonstrate compliance. These records are living documents that require updates as feedback is gathered, and plans for device monitoring evolve. The technical file encompassing device specifications, labeling, supplier information, design verification and validation, etc., must be updated continually. Clinical evaluation reports (CERs), periodic safety update reports (PSURs), summary of safety and clinical performance (SSCP), and other key documents that support the technical file must be updated within specified frequencies based on the device classification. Changes to these documents will trigger revisions to other supporting documentation such as the risk management report.

Notified bodies are required to review the technical file during a certification cycle (i.e., within five years). Also, they will review SSCPs and PSURs for implantable and Class III devices annually.

EU MDR Documentation Maintenance Requirements¹

*Although all reports have different submission schedules depending on the device classifications, it is the PSUR that will trigger the updates of the other documents.

OPERATIONAL CHALLENGES WITH POST-EU MDR COMPLANCE

There are several operational challenges facing companies after EU MDR certification as they deal with expansive document maintenance and reporting requirements.

Increased Workloads

Departments across the entire organization are hit with heavier workloads. Regulatory affairs must handle more document submissions and UDI updates. They also need to maintain product certificates and communications with notified bodies. Clinical and medical teams are now tasked with increased literature searches and clinical report updates. In turn, manufacturing and R&D teams must keep up with risk management reports.

Information Silos and Communication Gaps

Companies that rely on paper and other manual systems encounter even more hurdles when trying to maintain documentation. Because different groups are responsible for updating records, and information is disconnected, there’s often a data discrepancy across different business units. The lack of real-time cross-functional collaboration and transparency leads to improper planning and inefficient use of resources.

REDUCING THE BURDEN OF EU MDR COMPLIANCE WITH CLOUD QMS

In a survey conducted by Rimsys¹, 70% of regulatory affairs professionals reported that they spend most of their time on repetitive, administrative tasks. Furthermore, 50% of their time is spent simply searching for information. These figures will only be exacerbated with the additional EU MDR workload. To lessen the burden of compliance, companies will have to weigh their options. Do you hire additional resources (i.e., permanent employees, external consultants), reduce the number of products in the EU market, or adopt digital technology?

Investing in a Cloud-Native Enterprise QMS Solution

An ideal long-term option is to invest in an enterprise QMS solution. Cloud-native platforms like Arena QMS provide a centralized hub for organizations to efficiently manage all their product and compliance information throughout the entire lifecycle. With access to a single, unified system, everyone across the organization can collaborate in real time and stay aligned on the latest document updates.

Streamlining Compliance With Automated Documentation Management

Technical records, CERs, PSURs, and other compliance evidence link directly to the product bill of materials (BOM). Arena’s automated change processes and approval routings ensure updates are released promptly. By managing linked relationships between these records and any associated changes, Arena helps organizations gain better control of their documentation and ensure that everything is always accurate and up to date.

With information readily accessible in Arena, regulatory teams can quickly compile compliance evidence and expedite their audits. Ultimately, Arena QMS helps organizations spend less time managing documents and searching for files as they work toward EU MDR compliance.

Interested in learning more about EU MDR compliance? Read this white paper.

References

1. Rimsys and PA Consulting. Post-EU MDR Compliance: Key Insights and Activities to Maintain Compliance After Device Certification.