A new position paper from the Mirror-MDCG Clinical Working Group, composed of representatives from 11 Notified Bodies and approved by Team-NB, clarifies how data from off-label medical device use should be viewed and handled under the EU Medical Device Regulation (MDR) 2017/745. Distributed through the CIRCABC platform, the paper aims to harmonize understanding across Notified Bodies and manufacturers when such data emerge during clinical evaluation or post-market surveillance.

Understanding “Off-Label” Use Under MDR

The term off-label use is not explicitly defined in the MDR. However, Annex XIV, Part B—which outlines requirements for Post-Market Clinical Follow-Up (PMCF)—expects manufacturers to identify misuse or off-label use of their devices proactively as part of their ongoing data collection and analysis.
This is because off-label use, intentional or unintentional, can influence a device’s safety, performance, and benefit–risk profile.

Unlike the pharmaceutical sector—where “off-label use” is well established and tied to product labeling and authorized indications—the concept for medical devices remains less formally defined. In practice, off-label use refers broadly to a device being used outside its intended purpose as described in the manufacturer’s instructions for use (IFU) or technical documentation.

Why It Matters: Data Relevance and Clinical Evidence

The Team-NB position paper emphasizes that data generated from off-label use can sometimes offer valuable safety and performance insights—but such data cannot be directly used to support the intended purpose of a device unless carefully analyzed and justified.
Manufacturers should therefore:

• Identify and record instances of off-label use through PMCF and Post-Market Surveillance (PMS) systems.
• Assess relevance and scientific validity of such data when considering it in the clinical evaluation or trend reporting.
• Differentiate between misuse due to human factors and genuine clinical necessity or innovation.

Any insights drawn from off-label data must be clearly documented, and the rationale for inclusion or exclusion in the device’s clinical evaluation report (CER) should be justified according to MDR Annex XIV, Part A.

Implications for Manufacturers and Notified Bodies

For manufacturers, this position paper serves as a reminder that off-label use is both a risk management consideration and a potential data source. It requires active monitoring, not passive recording.
Notified Bodies, for their part, are expected to evaluate how manufacturers:

• Capture and categorize off-label usage events.
• Integrate off-label findings into PMCF and PMS activities.
• Apply conclusions from such data to risk–benefit assessments and updates to labeling or IFUs.

When recurring off-label use indicates a systematic clinical need not covered by the original intended purpose, manufacturers may need to initiate a design or labeling review and consider regulatory reassessment.

Moving Toward Harmonized Practice

By formalizing its view, Team-NB and the participating Mirror-MDCG Clinical Working Group aim to improve consistency and transparency across Notified Bodies when reviewing PMCF and CER documentation that includes off-label data.
This harmonization will help reduce uncertainty for manufacturers and contribute to more robust post-market evidence across the EU.

How MDx CRO Supports Manufacturers

MDx CRO assists manufacturers in integrating off-label monitoring into PMCF and PMS plans, ensuring that data handling and reporting align with MDR expectations.
Our team supports clinical evaluation, PMCF study design, and Notified Body submission strategy, helping you interpret real-world data responsibly—whether it originates from intended or off-label use.

Learn more about our Regulatory Affairs Services and Clinical Research Solutions, or contact us to discuss compliance strategies for MDR Annex XIV requirements.

To promote a consistent and transparent approach to EU MDR (2017/745) technical documentation submissions, Team-NB, the European Association of Notified Bodies, has published a new position paper outlining best practices for manufacturers and notified bodies.
This paper was developed collaboratively by Team-NB members to clarify expectations and reduce the most frequent causes of delay during conformity assessments.

Purpose and Scope

The position paper aligns with the requirements set out in Annex II and Annex III of the Medical Device Regulation (EU) 2017/745, which define the content and structure of technical documentation (TD) and post-market surveillance (PMS) documentation.
Its goal is to ensure that manufacturers provide sufficient, well-organized, and traceable information for notified bodies (NBs) to perform conformity assessments efficiently and without unnecessary delays.

Common Challenges Identified by Notified Bodies

Team-NB members noted two recurring issues that slow down or block the technical documentation review process:

1. Incomplete or insufficient information – key evidence or justifications for conformity with MDR requirements are often missing.
2. Disorganized or difficult-to-find information – documentation may contain all required elements, but scattered or inconsistent formatting makes evaluation inefficient.

These issues can result in requests for additional information, prolonged reviews, or even delays in certification.

Practical Recommendations from Team-NB

To improve the efficiency and consistency of submissions, Team-NB recommends that manufacturers:

• Clarify language requirements early. Contact your NB in advance to confirm acceptable languages for documentation and labeling (MDR Article 52).
• Ensure alignment between applications and TD content. Data in the application forms must match information in the technical documentation.
• Submit complete and current reports. Only finalized, unabridged test and verification reports should be included; partial or draft versions are not acceptable.
• Demonstrate conformity with each relevant GSPR. Include clear explanations showing how each General Safety and Performance Requirement (Annex I) is met.
• Maintain consistency across repeated sections. Where information appears in multiple places (e.g., device descriptions or labeling), confirm that all versions match to prevent contradictions.
• Provide justification for missing data. When evidence is unavailable, include a valid scientific or technical rationale instead of leaving sections blank.
• Reference prior NB assessments when relevant. If MDR requirements and supporting evidence are unchanged from previous directive assessments, note this explicitly to help streamline review.

Transitioning from MDD/AIMDD to MDR

Under MDR Article 52, manufacturers must submit an initial certification application to a Notified Body for devices requiring NB involvement.
While NBs may reference certain legacy assessments performed under the previous directives when appropriate, manufacturers remain responsible for providing comprehensive technical documentation that meets Annex II and Annex III in full.
Clearly identifying which evidence has changed (and which has not) can accelerate transition reviews and reduce duplication.

Key Takeaway

The Team-NB position paper reinforces that technical documentation is not only a compliance requirement but a communication tool between manufacturers and notified bodies.

Well-structured, complete, and consistent documentation supports both the manufacturer’s MDR certification timeline and the NB’s ability to demonstrate due diligence in its conformity assessment.

Manufacturers who implement these best practices will benefit from a more predictable and efficient review process, fewer delays, and greater regulatory confidence in their submission quality.

How MDx CRO Can Help

MDx CRO helps device manufacturers prepare MDR-compliant technical documentation and align it with Notified Body expectations.
Our team supports you in developing and reviewing Annex II/III files, GSPR checklists, PMS and PMCF documentation, and SSCPs—all formatted to match best practices recommended by Team-NB.

Learn more about our Regulatory Affairs Services and Clinical Research Support, or contact us to streamline your next NB submission.