Background
A global leader in acute care aerosol drug delivery approached Elion Medical Communications to develop clinical core claims to support their European Medical Device Regulation (MDR) submission.
The MDR replaces the previous Medical Device Directive and establishes a new legal framework for medical devices in the EU. All manufacturers must now comply with MDR requirements to maintain market access in the EU.
The client required a set of MDR-compliant clinical core claims to include in their Clinical Evaluation Report (CER). As their trusted medical writing partner for over 5 years, Elion was engaged to support the marketing, medical affairs and regulatory teams in the development of these core claims.
The Brief
Our role was to work closely with the client’s cross-functional teams – marketing, medical affairs and regulatory – to develop a set of clinically robust, MDR-compliant core claims within a tight timeframe. We were guided by a detailed brief outlining the CER context, clinical messaging priorities and supporting evidence.
Our Solution
This project was a collaborative effort with multiple stakeholders contributing to the development of the core claims. We used digital collaboration tools to implement feedback provided in real time together with regular calls to discuss queries and refine the language of the claims to ensure alignment with the broader submission strategy. The result was a cohesive set of MDR-ready clinical core claims, grounded in evidence and ready for inclusion in the CER.
Outcomes
We delivered MDR-compliant clinical core claims.
We developed a fully referenced set of claims in line with MDR requirements, enabling seamless inclusion in the CER and supporting a confident regulatory submission.
We liaised with cross-functional stakeholders to ensure strategic alignment.
Through a structured, collaborative review process, we brought together regulatory, medical affairs and marketing teams to ensure the claims were aligned with the client’s strategic objectives.
Our evidence-based claims framework strengthened our client’s clinical credibility.
The final claims reinforced our client’s reputation as a leader in evidence-based aerosol drug delivery, supporting both regulatory objectives and broader brand trust.
Looking ahead
As medical device regulations continue to evolve, there is a critical need for clear, evidence-based clinical claims.
Elion is committed to supporting clients with high-quality medical writing that enhances regulatory readiness and clinical credibility, helping them stay well positioned for ongoing success.
