Clinical Evaluation for Medical Devices
We support manufacturers in building strong, compliant clinical documentation under the EU MDR, including Clinical Evaluation plans (CEPs) and Clinical Evaluation Reports (CERs).
We ensure your device meets regulatory requirements, leveraging clinical data, literature, and strategic planning for successful CE marking.
Our Clinical Evaluation Services
- Clinical Evaluation Strategy development tailored to your device
- GAP analysis for existing clinical evaluation documentation
- Preparing CEPs and CERs, whether it is a new device or legacy device
- Literature search and state-of-the-art assessment
- Support with Notified Body clinical reviews
What Is a Clinical Evaluation Report (CER)?
A CER for medical devices is a comprehensive document that demonstrates the clinical evidence under MDR Annex XIV Part A, which aims to demonstrate safety, performance, and benefit-risk profile of your device.
It includes:
- Systematic literature review with MDR-aligned methodology
- Appraisal and analysis of clinical data
- Equivalence assessment MDR (where applicable)
- Integration with Post-Market Surveillance (PMS) and Post-Market Clinical Follow-Up (PMCF) , as well as Risk Management
Do all devices need one?
- Yes — all medical devices require a clinical evaluation, regardless of risk class.
The scope depends on the device type and pertinence of clinical data.
Why Choose Us?
- Solid expertise in MDR, MEDDEV 2.7/1 Rev. 4 and MDCG documents
- Proven track record with Notified Body clinical reviews
- Support across all device risk classes and therapeutic areas
- Transparent, audit-ready documentation
- Strategic guidance for CE marking and market access
Ready to Strengthen Your Clinical Evidence?
Whether you’re wondering how to develop a clinical evaluation plan or report or need a full-service partner to manage your clinical evaluation or ad-hocsupport, we’re here to help. Let’s build a compliant, efficient, and scientifically sound pathway to CE marking.
Contact us today to discuss your device, your needs, and receive a customized proposal!
