EU and U.S. Regulatory Considerations for Post-Market Advertising and Promotion of IVDs
Authorized in vitro diagnostic medical device (IVD) claims must be supported by a defined and appropriate body of evidence. However, the evidence base for an IVD’s clinical use often evolves over time. Peer-reviewed clinical literature, post-market studies, or real-world data may identify new potential applications for a test or additional patient populations in which it may be used safely and effectively. Regulatory frameworks in both the European Union and the United States make clear that such emerging evidence cannot be incorporated into advertising or promotional claims unless the associated use has been formally reviewed and cleared, approved, or authorized by the relevant regulatory authority. Manufacturers should still assess whether any new statements introduce a new intended purpose or intended use, even if the original claims were not subject to premarket review; the absence of prior review does not permit expansion of claims beyond what is supported in the device’s technical documentation or permitted under the applicable EU or U.S. regulatory framework.
Because the regulatory landscape continues to evolve, manufacturers should verify current requirements in both the EU and the US when developing advertising or promotional materials.
1. IVDR: Intended Purpose and Claims in Advertising
Under Regulation (EU) 2017/746 (IVDR) the concept of “intended purpose” is central to assessing whether advertising may mislead a user or patient. Article 2(12) defines intended purpose as:
“…the use for which a device is intended according to the data supplied by the manufacturer on the label, in the instructions for use, and in promotional or sales materials or statements, as well as in the performance evaluation.”
In practice, advertising is not ancillary to a device’s intended purpose, it is part of how the intended purpose is interpreted by regulators, including Notified Bodies.
Article 7 IVDR – Prohibited Claims
Article 7 prohibits the use of text, trademarks, pictures, or other signs that may mislead users or patients regarding the device’s intended purpose, safety, or performance. Prohibited practices include:
- ascribing functions or properties to the device that it does not have.
- creating a false impression regarding treatment or diagnostic functions or properties the device does not have.
- suggesting uses for the device outside the intended purpose for which conformity assessment was carried out.
Although the IVDR defines “label” (Article 13) and “instructions for use” (Article 14), it does not define advertising or promotional material. In practice, however, websites, brochures, slide decks, social media content, and congress booth materials are treated as advertising for purposes of Article 7.
If an IVD’s technical documentation and CE certificate do not encompass a particular intended purpose, marketing that use—even if supported by credible scientific evidence—will generally be considered misleading and outside the scope of the conformity assessment.
2. National Advertising Rules for IVDs in the EU
In addition to the IVDR, EU Member States retain authority over advertising and consumer-protection law. Many have specific requirements governing medical device and IVD advertising. These national provisions operate alongside the IVDR and may be more restrictive, particularly for consumer-facing materials.
Manufacturers must therefore consider both EU-level requirements and the national frameworks of each Member State in which the IVD is marketed.
The following examples illustrate national approaches but are not exhaustive.
2.1. Italy
On 21 July 2025, the Italian Ministry of Health issued “Guidelines on Healthcare Advertising for Medical Devices, In Vitro Diagnostic Medical Devices, and Medical-Surgical Products”. The Guidelines:
- explicitly apply to IVDs,
- require advertising to be truthful, objective, verifiable, and consistent with the CE-marked intended purpose and technical documentation, and
- address frequently raised issues such as website and social-media management.
Claims suggesting unassessed IVD use or purpose would generally conflict with these requirements.
2.2. Poland
Poland’s Act on Medical Devices (7 April 2022), together with the Ordinance of the Minister of Health on the Advertising of Medical Devices (21 April 2023), establishes a comprehensive regulatory framework for device advertising, including IVDs. Requirements are anchored in Article 7 MDR/IVDR and apply across all media formats. The rules include supervisory authority and sanctions, meaning that promotional claims exceeding the CE-marked intended purpose may trigger enforcement at both the national and EU levels.
2.3. Germany
In Germany, advertising of medical devices is governed by the Heilmittelwerbegesetz (HWG; Medicinal Products Advertising Act), unfair competition law, and the MDR/IVDR. Key HWG provisions relevant to IVDs include:
- Section 11 HWG – restricts certain forms of advertising practices, including misleading use of third-party statements and advertising directed predominantly at children under 14.
- Section 7 HWG – limits the offering of advertising gifts or other benefits to consumers, subject to narrow exceptions.
These provisions can impose stricter constraints than the IVDR, particularly for consumer-facing advertising.
2.4. France
In France, promotional activities are governed by the Public Health Code and the Charter on the Quality of Professional Practices for the Presentation, Information or Promotion of Medical Devices for Individual Use and Associated Services. The Charter emphasizes scientifically sound, objective communication and sets standards for interactions with healthcare professionals.
2.5. Spain
Spain’s Royal Decree 942/2025 updates the national IVD regulatory framework in alignment with the IVDR. National advertising and health-protection laws continue to prohibit misleading promotion of health-related products, and enforcement can occur independently of EU-level oversight.
2.6. Summary of EU National Requirements
Across the EU, Member State advertising laws consistently align with Article 7 IVDR in prohibiting claims that:
- overstate performance,
- minimize risks, or
- suggest clinical use beyond the CE-marked intended purpose.
However, national rules vary in specificity and often impose obligations beyond the IVDR. Manufacturers must therefore consider National as well as EU-level requirements.
3. U.S. Regulatory Framework: Intended Use, Promotional Claims, and Safe Harbor Mechanisms
The U.S. regulatory framework governing IVD advertising and promotion both mirrors and diverges from the IVDR. As under the IVDR, U.S. requirements rely heavily on the concept of intended use to determine whether a statement introduces a new, unreviewed claim. At the same time, FDA maintains policy-based mechanisms that permit limited, non-promotional scientific exchange regarding unapproved uses—mechanisms that have no direct analogue under the IVDR or in most EU Member State advertising laws.
3.1. Intended Use and Claims in Advertising
FDA’s intended-use regulation (21 C.F.R. § 801.4) establishes that intended use is determined not only by the statements in its labeling, but also by:
- advertising,
- manufacturer representations, and
- the circumstances surrounding product distribution and use.
This includes claims made in promotional materials, digital content, social media, scientific or investor presentations, and communications with healthcare professionals.
Promotion of Unapproved Uses
Under the Food Drug and Cosmetic Act (FD&C Act) and FDA’s intended use and misbranding authorities, a manufacturer’s communications suggesting an unapproved use for an approved or cleared device may be treated as evidence of a new intended use. Accordingly, FDA may determine that the device is:
- misbranded (e.g., promoted for an uncleared use), or
- adulterated (e.g., distributed without required premarket review).
FDA’s evaluation typically considers:
- Whether the promotional claim is inconsistent with the FDA-cleared or approved labeling, and
- Whether the communication constitutes evidence of intended use under 21 C.F.R. § 801.4.
When promotional materials introduce or imply a diagnostic, prognostic or clinical use outside the cleared or approved intended use, FDA generally views the claim as introducing a new intended use, requiring prior review.
3.2. FDA Safe Harbor Mechanisms for Scientific Exchange
Neither the IVDR nor any current EU-level or Member State guidance provides a structured mechanism for manufacturer-initiated scientific exchange on unapproved (off-label) uses. By contrast, FDA has issued guidance defining circumstances in which dissemination of scientific information regarding unapproved uses will not, by itself, be treated as evidence of a new intended use. These mechanisms are policy-based and:
- do not authorize promotional claims,
- do not alter FDA’s prohibition on off-label promotion, and
- provide a narrowly defined pathway for scientific exchange.
3.3 Distribution of Scientific and Medical Publications (Good Reprint Practices)
FDA’s 2009 “Guidance for Industry on Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices” outlines conditions under which FDA does not intend to treat dissemination of scientific or medical publications as evidence of a new intended use.
Materials must be:
- peer-reviewed journal articles, scientific or medical reference texts, or clinical practice guidelines,
- truthful, accurate, and unabridged,
- presented in a non-promotional manner,
- accompanied by clear disclosures that the use is unapproved,
- inclusive of study limitations and financial relationships, and
- physically and contextually separate from promotional materials, including exhibit booths, and sales discussions.
Importantly, the 2009 guidance facilitates scientific exchange with healthcare professionals, but does not authorize promotion of unapproved uses.
3.4. Scientific Information on Unapproved Uses (SIUU)
FDA’s 2025 guidance “Communications from Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products” – provides FDA’s most comprehensive safe-harbor-type framework.
When SIUU criteria are met, FDA:
- will not use the communication, standing alone, as evidence of a new intended use, and
- does not expect prior FDA submission.
SIUU communications must be:
- truthful, scientifically sound, and non-misleading,
- tied to accepted “source publications”,
- accompanied by disclosures, including study limitations and financial relationships,
- clearly distinguished from promotional content; and
- supported by valid scientific evidence for devices, as defined in 21 C.F.R. § 860.7.
3.5. Combined Observation
FDA’s policies create a two-tiered structure:
- promotional communication must remain within the cleared or approved intended use, and
- limited, non-promotional scientific exchange is permissible under defined safe-harbor criteria.
4. Practical Implications for IVD Advertising and Scientific Exchange
Key implications for manufacturers operating in both jurisdictions include:
- EU: Article 7 IVDR treats promotional communication as part of the intended purpose, and Member State advertising laws often impose additional restrictions.
- U.S.: FDA’s intended-use framework prohibits off-label promotion, but safe-harbor mechanisms permit certain scientific exchange under defined conditions.
- Across both systems: scientific exchange and promotion are treated distinctly; however, information that is permissible in scientific exchange may not be used in promotional materials until regulatory status is updated.
Manufacturers must therefore ensure that marketing, medical affairs, and commercial teams align communications with regulatory requirements in each jurisdiction.
How Beaufort Can Help
Beaufort’s regulatory team provides technical support across the full lifecycle of medical devices and IVDs. We work with manufacturers to evaluate proposed claims against IVDR requirements and Member State advertising laws, as well as FDA’s intended-use, misbranding, and scientific-exchange frameworks. Our team assists in:
- developing compliant promotional and scientific communications,
- reviewing scientific information on unapproved uses for potential claim expansion,
- supporting interactions with regulators, and
- advising on internal review processes that accommodate evolving evidence while maintaining regulatory integrity.
Our emphasis is on ensuring that external communications—whether promotional or scientific—remain aligned with the device’s cleared or approved intended use or authorized intended purpose, enabling responsible dissemination of information while safeguarding compliance in both the EU and U.S. regulatory environments.