Case Study: Gap Analysis and CER Remediation for a Global Medical Device Company

Background – Client Needs:

A US-based non-invasive radio-surgical equipment manufacturer was looking to obtain the CE Mark for their Class IIb device and introduce it in the European market. The device approved by the FDA and marketed in the US. The client sought support with transitioning to the Medical Device Regulation (MDR) European Union (EU) Regulation 2017/745 regarding their Technical File and remediation of the Clinical Evaluation Report (CER). While the client already had all documentation in place per the Medical Device Directive (MDD), they had received observations from the Notified body (TUV SUD) on their previous submission.

The client faced the following challenges:

The client aimed to address the observations and assess gaps in their current technical documentation to ensure that the device conforms to the requirements of the EU MDR. Another challenge that the client faced was the lack of adequate clinical data on the device, which was expected as the device was commercialised only in 2018.

  • GSPR (I)

  • Label (I)

  • IFU (I)

  • TF Doc (II)

  • TF Doc PMS (III)

  • DoC (IV)

  • Classification (VIII)

Project Initiation & Key Objectives:

The client chose to leverage Celegence’s team of CER experts to support this Gap Analysis and CER Remediation Project based on our extensive expert network and ability to complete the project in a cost-efficient and timely manner. The scope of Celegence activities was to conduct a thorough Gap Analysis of the Technical File for compliance with the EU MDR, and also remediate the Clinical Evaluation Report to present a robust summary of evidence on the device and compliance to the General Safety and Performance Requirements (GSPRs). The team was also expected to engage in regular project monitoring and timely status reporting.

Celegence Solution & Approach:

Celegence partnered closely with the client for analysing gaps in the Technical File and remediating the CER.

  • Technical file documentation assessment for gaps in compliance to EU/MDR 2017/745 and other applicable standards for a Class IIb device was performed by Celegence professionals.
  • Subject matter experts in Radiosurgery and Software requirements of the regulation were involved.
  • Celegence worked closely with the client to develop a literature search strategy, identify similar devices and analyse the available clinical data gathered from the market experience of the device.
  • The Celegence team authored the Clinical Evaluation Plan, and the Clinical Evaluation Report including the Literature Search Report in compliance to EU/MDR 2017/745 and MEDDEV 2.7/1 Rev.04. The literature search strategy for CER had to be modified to leverage data available on the treatment modality itself and create a robust State of the Art discussion.

Key Project Achievements

Celegence delivered high quality clinical documentation which included:

  • Comprehensive Gap Analysis report as well as templates leveraging industry best practices
  • 100% quality & timeline delivery performance despite tight timelines, an achievement in collaborating with Celegence’s expertise
  • Classroom training on authoring CER in compliance EU Medical Device Regulation
  • Gap analyzed for 282 clauses
  • 700+ documents reviewed
  • Close to zero observations
  • Clinical Evaluation Plan and Clinical Evaluation Report including the Literature Search Report

Key to the success of the partnership was involving experts and experienced resources, while incorporating proper quality control measures in analyzing gaps and creating the CER.

Celegence has a wealth of knowledge to help you navigate through the complex regulatory challenges brought forth by the EU MDR. We can assist you throughout the entire process to ensure that you and your business are compliant with all EU MDR requirements.

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