Why accurate product data is a compliance imperative in the MedTech world

Medical device recalls and certification delays are increasingly linked to issues stemming from incomplete or inconsistent product data.

In 2024, Boston Scientific was forced to revise usage instructions for its POLARx catheter after safety concerns led to a Class I FDA recall. ZOLL Medical had to correct documentation on MRI safety for its ventilators to avoid misuse.

Across the EU, companies submitting MDR (Medical Device Regulations) are reporting stalled approvals due to missing or mismatched data in their technical files.

These incidents highlight a growing trend: regulators now expect every data point, from labeling to digital identifiers, to be current, accurate, and traceable.

In the medical technology sector, product data has become a compliance requirement, not a supporting asset.

What is the role of product data in MedTech compliance?

In medical technology, product data includes all the structured information needed to classify, approve, and safely use a device. This spans:

• Technical specifications
• Materials and composition
• Dimensions and packaging details
• Labeling content and claims
• Usage instructions and warnings
• Digital UDI (Unique Device Identifier) information

This data must remain consistent across regulatory submissions, internal systems, and public-facing materials.

Why does accuracy matter for compliance

Global regulations increasingly depend on the integrity of product data. When fields are missing, inconsistent, or outdated, approvals can stall, or devices can be pulled from the market.

Key compliance systems that rely on this data include:

FDA UDI (21 CFR Part 830)

The FDA requires medical device makers to assign UDIs and submit product details to the Global Unique Device Identification Database (GUDID). Any errors in device identifiers, descriptions, or status updates can trigger compliance issues and lead to market disruption.

EU MDR and IVDR

Under EU regulations, manufacturers must maintain detailed technical documentation and labeling that match specific classification and safety rules. Every data point, such as device description, packaging, or claims, must be complete and traceable to gain and keep CE marking.

GS1 standards

GS1 provides global rules for how product identifiers, such as GTINs and barcodes, are structured and used. These standards ensure interoperability across systems, helping manufacturers manage regulatory and commercial data consistently across borders and trading partners.

EUDAMED

EUDAMED (European Database on Medical Devices) is the European Commission’s central platform for medical device registration. It collects structured product data tied to device risk, usage, manufacturer details, and certifications. Submissions must meet strict format and content rules to be accepted without delays.

When product data is flawed, it creates risk across both compliance and commercial channels. What’s submitted to regulators must align with what hospitals, clinicians, and partners see on screen or in print.

When product data goes wrong: Real-world examples

Mistakes in product data don’t always cause a device to fail, but they often shape how regulators respond when something goes wrong. Several recent recalls show how essential it is to have accurate, complete, and up-to-date product documentation in place.

Boston Scientific POLARx Catheter

In late 2024, Boston Scientific issued a Class I recall for its POLARx Cryoablation Balloon Catheters following reports of atrio-esophageal fistulas, a rare but serious complication.

The company responded not with a product redesign, but with an update to the instructions for use, adding new safety guidance.

The root issue wasn’t flawed hardware. It was the need to revise the information that accompanied it.

Abiomed Impella Heart Pump

Abiomed faced a Class I recall for its Impella left-sided blood pumps after reports of left ventricular perforation. In response, the company updated its instructions for use and training materials to include new warnings about the risk of perforation.

This corrective action centered on product documentation, specifically how critical safety information was communicated to clinicians.

Exactech Joint Replacement Device

Exactech issued a recall of certain knee, ankle, and hip replacement devices due to defective packaging that failed to protect the plastic inserts from oxidation. This oxidation could lead to premature wear, device failure, and the need for revision surgery.

According to the FDA, the issue stemmed from non-conforming vacuum bags that did not contain a necessary oxygen barrier layer.

Although the core problem involved physical packaging, it raised broader concerns about quality control and documentation. Identifying which devices were affected required traceable product data and detailed packaging records.

These cases show a clear pattern: even when the device itself isn’t defective, regulatory responses often rely on data corrections, documentation updates, and traceability to resolve the issue.

The high cost of poor data governance

Medical technology companies operate in one of the most regulated and high-trust industries. When product data is inaccurate, outdated, or scattered across systems, the consequences are costly and far-reaching.

Regulatory and financial risk

• Missed fields or mismatched records can delay approvals or trigger warning letters.
• Incomplete submissions may result in product holds or market withdrawals.
• Non-compliance with UDI or MDR requirements can lead to severe consequences, including hefty fines, seizure, significant revenue loss, and other penalties.

Reputational damage

• Incorrect labeling or usage of documentation damages trust with regulators, clinicians, and partners.
• Even a single documentation error can raise concerns about quality and oversight.

Operational inefficiencies

• Disconnected systems often lead to duplicate records and version control issues.
• Manual updates across teams increase the risk of inconsistent submissions.
• Time and resources are wasted resolving preventable errors under regulatory deadlines.

Today, many companies continue to manage essential product data across disconnected tools and teams. Without a reliable, centralized data model, teams face mounting pressure during audits and submissions.

Strong data governance reduces risk, streamlines operations, and supports faster access to global markets, where accuracy is not just expected but required.

How does accurate product data create a competitive advantage?

Accurate product data drives growth, improves time to market, and strengthens performance across global and digital channels.

Companies that invest in high-quality data can move faster, scale more efficiently, and reduce friction throughout the product lifecycle.

Speed to market

Well-managed data helps teams avoid delays during the approval and launch phases.

• Submissions meet requirements the first time, avoiding resubmissions or rework.
• Approval cycles are faster when regulators receive complete, properly formatted documentation.
• Cross-functional teams spend less time tracking down or fixing product details.

Global scalability

Accurate data supports smoother registration and market entry across countries.

• Localized versions of product records are easier to produce and maintain.
• Compliance with country-specific labeling and classification is simpler when the base data is structured correctly.
• Central oversight helps manage changes across all regions consistently.

Seamless syndication

Product data is not only shared with regulators. It also needs to be published across sales and internal systems.

• EUDAMED and GUDID platforms require precise, structured inputs.
• Distributors and retailers depend on up-to-date specs and labeling information.
• Internal users, from marketing to regulatory, can rely on a single, approved version.

How a PIM platform like Inriver solves these challenges

Managing product data across multiple systems and teams can lead to inconsistencies, delays, and compliance risks.

Inriver’s Product Information Management (PIM) platform addresses these challenges by providing a centralized solution that ensures data accuracy, streamlines workflows, and facilitates seamless integration with regulatory and commercial endpoints.

Centralized product information

• Single source of truth – Consolidates all product data, ensuring consistency across departments and channels.
• Data accuracy – Reduces errors by maintaining up-to-date and validated information accessible to all stakeholders.

Efficient workflow management

• Change tracking – Monitors modifications, providing a clear audit trail for compliance purposes.
• Version control – Maintains historical records of product data, aiding in traceability and regulatory reporting.
• Workflow automation – Streamlines approval processes, reducing time-to-market and minimizing manual intervention.

Seamless integration

• Regulatory compliance – Facilitates direct integration with systems like EUDAMED and GUDID, ensuring timely and accurate submissions.
• Commercial syndication – Enables real-time distribution of product information to retailers, distributors, and internal platforms.

Customer success story: Michelin

Global manufacturer Michelin implemented Inriver’s PIM solution to overcome challenges in maintaining accurate and compliant product data across various contributors.

The platform simplified internal and external collaboration, ensuring the latest and most accurate product information was readily available.

This transformation enhanced their digital growth and streamlined the distribution of data to third-party channels and distributors.

Inriver’s PIM platform empowers organizations to manage complex product data efficiently, ensuring compliance, enhancing operational efficiency, and supporting global scalability.

“We wanted people from our company, not too technical, to go inside the PIM and do easy things. That was one of the reasons we chose Inriver.”

– Lucile Logel

PIM/DAM Leader at Michelin

Strengthen MedTech compliance through better product data management

As regulatory demands grow and data complexity increases, medical technology companies need reliable systems to manage it all. Now is the time to assess your product information workflows, identify gaps, and strengthen your data governance.

Inriver’s PIM platform helps manufacturers streamline compliance, reduce risk, and prepare for global expansion. Learn how Inriver can support your team in building a strong foundation for product data accuracy. Get in touch to start the conversation.