Targeted clinical evaluation helps achieve EU-MDR compliance

Ramboll was commissioned to perform a full clinical evaluation of an irrigation solution previously marketed under the Medical Device Directive 93/42/EEC (MDD). Following reclassification to a higher risk class under the EU-MDR, the manufacturer required a more comprehensive clinical justification aligned with EU-MDR requirements and relevant Medical Device Coordination Group (MDCG) guidance.

Ramboll prepared a complete clinical evaluation package, including a clinical evaluation plan (CEP), clinical evaluation report (CER), targeted literature searches, and post-market clinical follow-up (PMCF) documentation.

We structured the process into four focused steps to build a robust and compliant clinical evidence base.

Step 1: Data review and gap analysis

We began by reviewing all device-specific material available to the client, including product history, preclinical testing reports, labelling, instructions for use, risk management files, and PMS records. We then performed an EU-MDR-aligned gap analysis to identify insufficient clinical evidence in light of the device’s reclassification to a higher risk class.

Step 2: State-of-the-art and literature review

Due to the limited availability of device-specific clinical data, Ramboll conducted targeted, systematic literature searches to assemble clinical evidence from comparable irrigation solutions and assess the current state of the art. This evidence was used to support performance claims and to evaluate the safety profile.

Step 3: Integration of preclinical and PMS evidence

We conducted a thorough review of preclinical results, bench testing data, and the device’s legacy CE-mark history. Extensive real-world PMS data were leveraged to demonstrate ongoing safety and effectiveness and to address in direct clinical evidence.

Step 4: PMCF strategy and documentation

We developed the CEP, CER, and the corresponding PMCF documentation, outlining pragmatic methods for continued data collection and monitoring of performance and safety. All documents were cross‑referenced to EU-MDR requirements and relevant MDCG guidance. Ramboll finalised the CEP, CER, and PMCF documentation, prepared submission‑ready files, and provided guidance to support the client’s submission to the notified body.

Results and client value

Ramboll’s thorough client data evaluation, combined with robust literature evidence and PMS insights, proved instrumental in ensuring the client’s irrigation solution adhered to the stringent EU-MDR safety and performance standards. The clinical evaluation package was accepted by the notified body without further comments, enabling continued market access under the EU-MDR.