Marketing documents for medical devices, such as brochures, websites, videos, and advertisements, must be carefully crafted to ensure compliance with the Medical Device Regulation (MDR) (Regulation (EU) 2017/745). These documents should accurately reflect the device’s nature, performance, and safety while being supported by valid evidence.
What are the general principles to follow when creating marketing materials for medical devices?
1. Accuracy and Truthfulness
- All marketing materials must be truthful and not misleading. Any claims about the device must be backed by valid evidence that aligns with the device’s intended use and performance as outlined in its technical documentation, such as the technical file, instructions for use (IFU), and labelling.
2. Consistency
3. Evidence-Based
- Every claim made about the device should be supported by adequate scientific evidence, which may include clinical studies, preclinical testing, post-market surveillance data, or literature reviews.
4. Regulatory Compliance
- Marketing documents must comply with the MDR’s requirements and should be developed with input from the regulatory team to ensure alignment.
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