The Growing Importance of Core Claims in Modern Medical Practice
In 1950, medical knowledge was estimated to double after 50 years; in 1980, after 7 years; and in 2010, after 3.5 years. In 2020 it is estimated to double every 73 days.1 Medical practices rapidly change; either becoming obsolete or applicable only to narrow patient groups. As knowledge evolves, regulatory and legal frameworks are constantly updated, pushing pharmaceutical and medical device companies to keep pace.
The EU Medical Device Regulation (MDR) framework, published in 2017, came into full effect in 2021 (with transition periods in place for existing devices). It repealed previous directives and significantly raised the standards for substantiating clinical and technical claims. The regulation aims to increase patient safety and ensure medical devices meet stringent quality standards before being marketed in the EU. However, its tight deadlines and multi-stakeholder demands have placed enormous pressure on companies to produce high-quality, evidence-based documentation in short timeframes. This is where medical writers play an important role; bridging scientific rigor with regulatory framework, to ensure claims are evidence-based.
What Core Claims Are
Core claims are scientifically validated statements about a product’s intended purpose and are grounded in high-quality clinical trials and efficacy data. A core claims document compiles these statements and serves as a central reference for internal regulatory, medical affairs, and marketing teams. This ensures that every claim, whether aimed at healthcare providers or the public, is consistent, evidence-based and verified by its original source. With this framework, teams can ensure consistency of claims across marketing materials and ensure claims don’t mislead the user with regard to the device’s intended purpose, safety and performance.
Why Core Claims Matter
While core claims are essential for meeting requirements such as Clinical Evaluation Reports (CERs), their utility extends far beyond compliance. They provide a unified foundation for marketing and medical content, ensuring that all messaging is aligned, scientifically sound, and free of contradictions. By centralising claims and references, companies can avoid duplication, streamline content development, and strengthen brand credibility across markets.
How to Leverage Core Claims Effectively
To fully realise the value of core claims, companies should begin the process early – ideally during product development – and involve cross-functional teams from the start. Regulatory, medical, marketing, and legal teams should collaborate to ensure claims are not only compliant but also support both scientific integrity and commercial goals. Early investment in a robust core claims framework can significantly reduce rework, accelerate internal medical-legal-regulatory approvals , and improve market readiness.
Read our case study on how Elion supported a long-standing client to develop core claims to comply with MDR requirements.
Medical knowledge is expanding at an unprecedented rate, driving constant changes in regulations such as the MDR, which demands stronger evidence for medical core claims. Core claims serve as a unified reference for teams to ensure consistent, evidence-based messaging. Beyond compliance, they streamline content creation, reduce duplication, and strengthen brand credibility.
Planning your next product launch? Let’s talk about how Elion can support you with claims, content and campaign materials that make an impact. https://elion.nz/get-in-touch/
