Case Study
Achieving EU-MDR Compliance for a Class IIb Glaucoma Implant
THE CLIENT CHALLENGE
- ✔ The client (a global medical technology company that manufactures and sells ophthalmic implants) wanted to submit CER for their glaucoma implant for EU-MDR compliant
- ✔ They wanted us to review and update their CER and provide strategic inputs to their team to manage NB’s queries and ensure successful acceptance of their device as EU-MDR compliant
THE OBJECTIVES
- ✔ To review the authenticity of clinical data and CER vis-à-vis MDR requirements
- ✔ To understand the device description and similar device landscape and define the SOTA requirements appropriately
- ✔ To provide training to the client team on writing high quality CEP and CER
- ✔ To understand the NB’s queries and provide strategical inputs and suggestions to the client team to address them
OUR APPROACH
- ✔ 3-phased approach:
- ✔ Phase1: Analysis of current technical/clinical files to check the status of clinical data to rectify any clinical gaps
- ✔ Phase 2: Analysis of SOTA section to meet the definition of SOTA as per MDR (to address the NB’s comment)
- ✔ Phase 3: Training and aligning the client team to finalize CEP, literature search protocol, and CER for submission.
THE SCOPE
- ✔ CER gap analysis and literature review and updating the CER accordingly
- ✔ Addressing NB’s queries on the CER
- ✔ Timeline: 2 weeks
Outcome
- Phase 1 Outcomes:
- ● We provided appropriate suggestions on CEP, literature search protocol, and CER, helping the client redraft the documents quickly and in compliance with MDR/MDCG guidelines
- ● We redlined the CER and rearranged the flow of clinical information as per the stages of clinical evaluation and provided the appropriate/applicable GSPR section for the same
- ● We assessed the risk class of the device and uncertainties associated with it due its high residual risk and critical anatomical functional site and advised better approach and justification for their PMCF studies.
- Phase 2 Outcomes:
- ● We understood the NB queries regarding the SOTA and reframed the approach, which highlighted the subject device standpoint in the current field of medical practice with data supporting the performance and safety of the subject device in comparison to other benchmark/similar device.
- Phase 3 Outcomes:
- ● All the queries raised by NB with respect to article shall be well summarized to give a better clarity on the Safety and Performance in the CER
- ● Literature search protocol shall focus to extract article stating long term benefits and safety parameter of the Implant and similar devices
- ● The summaries of clinical trial data shall be checked to thoroughly support the clinical end point of Glaucoma Implant
- ● The summary of the clinical evaluation shall include all unknown risk or side effects shall be clearly stated, the risks associated with Glaucoma
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Cetas Healthcare is a global leader in conducting ISO 14155-compliant Post-Market Clinical Follow-up (PMCF) surveys for MedTech devices. We specialize in designing and managing robust PMCF studies that capture real-world clinical evidence for Class II and III devices. To date, we’ve handled 25,000+ patient case forms, enabling clients to strengthen CE certification submissions and maintain full compliance with EU MDR requirements. By combining rigorous clinical research with actionable insights, we help MedTech companies continuously monitor device performance and enhance patient safety.
Contact Us: communication@cetas-healthcare.com
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