Meeting the ever-evolving demands of global regulators while, at the same time, delivering safe, high-performing medical devices is a huge challenge. As regulatory scrutiny intensifies, so does the pressure to deliver solid, comprehensive Clinical Evaluation Reports (CERs) that meet the requirements of Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) and withstand critical review. This is something that can quite easily stretch the most capable internal resources.

With decades of experience and a global team of multidisciplinary experts, the Eurofins Medical Device Consulting can support device manufacturers at every stage of the clinical evaluation process. Whether you're launching a new device or maintaining compliance through Post-Market Clinical Follow-Up (PMCF), our scientists, regulatory consultants, and medical writers bring clarity and confidence to complex clinical data.

We offer a structured, risk-based approach that aligns with MEDDEV 2.7/1 Rev. 4 and EU MDR/IVDR requirements. Working closely with your internal teams, we can help develop and execute clinical development plans, review and analyse data, and produce high-quality CERs and literature evaluations.

Services:

• Gap analysis and strategic planning for clinical development
• Clinical evaluation report (CER) writing and updates
• State-of-the-art literature searches and appraisals
• Data analysis to support regulatory submissions
• PMCF planning, execution, and reporting
• Compliance with EU MDR and IVDR

From strategic input to final submission, we combine regulatory insight with scientific rigour to ensure your clinical evidence supports claims of safety and performance, and that your CERs are delivered on time, in full compliance.