Under the Medical Device Regulation (MDR) (Regulation (EU) 2017/745), marketing claims made about medical devices must be carefully documented to ensure compliance with the regulation, protect consumer safety, and ensure the accuracy of information. Proper documentation is critical to support the validity of the claims and demonstrate that they are truthful, substantiated, and consistent with the device’s intended use and regulatory approval.
Here’s how marketing claims should be documented under the MDR:
1. List of Marketing Claims
- What It Is: A comprehensive and detailed list of all marketing claims made about the medical device. This includes every claim that will be communicated to the public or healthcare professionals, such as those in brochures, advertisements, websites, and product labeling.
- What Should Be Included:
- Description of each claim: A clear and precise statement of the marketing claim being made (e.g., “The device reduces healing time by 20%”).
- Supporting evidence: A reference to the documentation or scientific evidence that supports the claim (e.g., clinical trial results, preclinical studies, literature reviews, etc.).
- Limitations or clarifications: Any caveats or qualifications necessary to avoid misleading or exaggerated claims (e.g., “Results may vary depending on patient condition”).
- References: Citations or links to relevant supporting documents, such as clinical studies, risk assessments, or performance testing results.
2. Evidence Supporting the Claims
- What It Is: All claims must be backed by appropriate scientific evidence, such as clinical studies, performance testing, preclinical data, or post-market surveillance. Documentation of this evidence should be easily accessible and referenced for each claim.
- What Should Be Included:
- Clinical studies: The results from clinical trials or studies supporting safety, efficacy, and performance claims (e.g., “Clinical trials demonstrated a 25% faster recovery time using the device”).
- Preclinical data: Bench testing, animal studies, or in vitro data that support claims made about device functionality or performance (e.g., “Preclinical testing showed the device performs as intended under stress conditions”).
- Post-market surveillance data: Real-world data collected after the device has been marketed, such as user feedback or reported adverse events (e.g., “No adverse events reported in 1,000 units used in the field”).
- Literature reviews: Summaries of peer-reviewed articles or other published research that support the device’s claims (e.g., “Studies show similar devices have a 10% greater success rate”).
3. Approval Process for Marketing Claims
- What It Is: Before any marketing materials containing claims are released to the public, they must undergo a formal approval process to ensure they are scientifically substantiated and comply with the MDR.
- What Should Be Included:
- Review and approval through the Quality Management System (QMS): Claims should be reviewed by relevant departments (e.g., regulatory affairs, legal, and quality management) to ensure that they are supported by appropriate evidence and do not violate any regulatory requirements.
- Approval hierarchy: Clear documentation of the internal process that leads to the final approval of claims, with designated reviewers and decision-makers.
- Version control: Tracking of the various versions of marketing materials and claims, ensuring that outdated claims are updated or removed.
4. Documentation of Images and Visual Claims
- What It Is: Any visual representation (images, diagrams, videos) used in marketing materials must be supported by the same level of documentation as written claims.
- What Should Be Included:
- Accurate representation: Documentation should confirm that any images used accurately reflect the device and its performance characteristics as outlined in the technical documentation (e.g., “The image accurately represents the device size and functionality”).
- Evidence to support the image: If the image or visual representation makes a claim (e.g., “The device reduces infection risk”), it must be supported by the corresponding scientific data or studies.
- Version control for images: Just like textual claims, images should be tracked for updates or changes to ensure consistency with the most recent data or device features.
5. Consistency with Technical Documentation
- What It Is: All marketing claims must be consistent with the information in the device’s technical documentation, including the technical file, instructions for use (IFU), and labeling.
- What Should Be Included:
- Cross-referencing: Ensure that every marketing claim aligns with the intended use, performance characteristics, and indications for use as described in the technical documentation.
- Regulatory alignment: Marketing claims should reflect the regulatory status of the device, ensuring that no claims are made outside of what has been approved by regulatory bodies (e.g., the CE marking or FDA clearance).
- No misleading claims: Ensure that claims made in marketing materials do not go beyond the device’s approved indications or exaggerate its capabilities.
6. Post-Market Surveillance and Monitoring
- What It Is: Marketing claims should be continuously monitored after the device is on the market to ensure they remain accurate and aligned with real-world data.
- What Should Be Included:
- Ongoing surveillance: Collect and review feedback from users, healthcare professionals, and other stakeholders to detect any potential issues with claims or unintended consequences.
- Update and revision process: If new data becomes available that affects the validity of a marketing claim, the claim should be updated or removed from marketing materials. This process should be documented.
- Corrective actions: If any misleading or incorrect claims are identified, corrective actions must be taken, such as issuing updated marketing materials or notifying regulators, depending on the severity of the issue.
7. Regulatory Compliance Documentation
- What It Is: Marketing claims must be developed in accordance with the requirements set forth in the MDR. Documentation should show that the claims were created with input from the regulatory affairs team to ensure full compliance.
- What Should Be Included:
- Regulatory review: The marketing claims must be reviewed by the regulatory affairs team to ensure they comply with MDR requirements.
- Clear identification of relevant regulations: The claims should refer to specific provisions of the MDR that justify or validate the marketing statement (e.g., claims related to safety or performance).
To ensure compliance with the MDR, medical device manufacturers and marketers must document all marketing claims thoroughly, ensuring that they are scientifically supported, aligned with regulatory requirements, and accurate. This documentation process should include maintaining comprehensive lists of claims, referencing appropriate evidence, obtaining internal approvals, and continuously monitoring marketing materials post-market for ongoing compliance.
Click here to read the supporting evidence that you can use to prove your medical device marketing claims.