The Latin expression “Dura lex sed lex” translates to “The law is harsh, but it is law,” and encapsulates the obligation to abide by the law, even when it’s stringent. This sentiment might resonate as you have been navigating the requirements of the EU MDR. In particular, Article 7 of the MDR forbids misleading claims in all product communications, mandating claims to be backed by clinical data and aligned with a device’s intended use, safety, and performance.
“EU MDR compels MedTech companies to rethink their promotional materials’ compliance. Notified bodies now scrutinize not just product use instructions but also websites, brochures, and other commercial content. All product claims must be clear, backed by evidence, and regulatory-approved.”
– Bassil Akra, CEO, AKRA TEAM
We had the privilege of interviewing Bassil Akra, founder of Akra Team, former Vice President of Strategic Business Development at TÜV SÜD, and seasoned expert in EU regulations regarding claims and content. Here are some insights he shared for ensuring success as you approach your claims strategy under EU MDR.
When to Initiate Claims Management and Stakeholders’ Roles
Bassil suggests that claims management should commence early in the product development process, involving key stakeholders such as marketing, sales, clinical and R&D. Collaboration between these departments and alignment with the clinical evidence plan is essential; ensuring the direction of your draft claims supports the product’s market entry.
Impact of Claims Management on Market Entry
Bassil highlights, “Documentation which is deficient leads to delays.” Crafting clear claims connected to evidence from the outset minimizes unnecessary questions and challenges, enabling smoother market entry. It is critical to clearly define, early, what you want to say and do. The commercialization plan should also include a budget toward the appropriate clinical investigations required to support critical claims.
By meticulously crafting and submitting claims alongside evidence from the outset, you preempt challenges from regulatory bodies, which carry more stringent penalties under new regulations.
Elevated Consequences for Non-Compliance
Bassil emphasizes that claims can be high-stakes, as they can influence how a device is used and potentially pose risks. While the new European requirements aren’t entirely novel to the industry, they have evolved from directives to stringent regulations. What was previously sporadically enforced is now legally mandated with specific articles dictating what must be done and how.
Bassil further emphasizes, “Article 7 of the MDR squarely addresses claims. Falsified or misleading claims, off-label promotion, or misuse pose substantial risks to patients. Such acts are deemed criminal and could result in severe penalties, even jail time. Manufacturers must tread carefully—how they communicate about their products and substantiate their claims can impact users or patients, leaving manufacturers accountable.”
Categorizing Claims for Substantiation
The qualification of a claim is pivotal in determining the kind of evidence needed to support it. Clinical claims demand clinical supportive evidence, while technical claims require technical supportive evidence. Thus, strategic categorization of claims and alignment with evidence is paramount and the claims that can be made for a product will evolve across its lifecycle, from development to post-market feedback.
As Bassil highlights, “Claims management is intricate, demanding cross-team coordination and multiple steps. Ultimately, manufacturers must present evaluators with a well-structured list of claims, substantiated by accessible supporting evidence. They’re assessing consistency, accuracy, and substantiation.”
EU MDR’s Global Influence
The CE mark, signifying conformity with EU safety and performance requirements, extends beyond Europe’s borders. Bassil explains, “CE mark is also used as a market entry for other non-European countries.” Therefore, consistency in claims across markets is essential. Harmonizing claims across markets becomes vital, influencing how manufacturers present their products globally.
Portfolio Rationalization
Bassil underscores the need for innovative thinking and data-driven decisions in product re-certification or introducing new products. An extensive product range isn’t necessarily the goal; quality matters. Marketing and regulatory alignment should determine the products that truly merit market presence, considering competitive landscapes, existing claim evidence, and the efforts required to maintain or establish market presence.
While the level of rigor brought on by EU MDR represents a significant shift, it also offers a path to readiness that can benefit your company, patients, physicians, and the industry overall. By integrating a robust claims strategy, with appropriate substantiation and evidence, you’re better poised to navigate an evolving landscape of medical device regulations.
For more insights into claims management and perspectives from industry, watch this on-demand webinar “Commercial Content & Claims: Cracking the Regulatory Code” featuring Bassil and Becki Brasher, Senior Regulatory Manager, Ad Promo, for Medtronic.
To learn about Veeva’s solutions that help streamline claim management, please reach out to your Veeva Account Partner or visit veeva.com/medtech/promomats.
Ramona Galantonu, PhD, Director, Commercial Strategy, Veeva MedTech EU