Case Study: MDR Consulting Support – Neuro-Oncology & Interventional Radiology Product

Background – Client Needs:

The client is the manufacturer of a Class IIb computer-controlled system for performing non-invasive stereotactic radiosurgery of lesions in the brain, head and neck.

The system consists of both hardware and software components, including a linear accelerator that provides the therapeutic radiation source and a kV imaging system to locate the treatment target.

Project Initiation & Key Objectives:

The manufacturer approached Celegence for regulatory guidance for the device’s initial CE-marking and approval in the EU.

Celegence Solution & Approach:

Celegence supported the client for the following activities for the Class IIb radiosurgery device:

  • Gap assessment of the device’s Technical Documentation and CER per Annex I, II, III, IV, VIII of the EU MDR for approximately 700 source documents, including requirements applicable to software.
  • Celegence further supported the customer in the initial CE-marking of the device by creating an MDR compliant Clinical Evaluation Plan (CEP), Clinical Evaluation Report (CER), Literature Search Report (LSR), and in drafting responses to Notified Body (NB) observations on the CER.
  • The Celegence team also performed remediation of the CER to meet NB expectations.

Project Achievements

The device successfully received its CE Mark clearance. The client further extended their partnership with Celegence for the device’s Post-Market Clinical Follow-up report and yearly maintenance-CEPs and CERs.

Project Outcomes

Key to the success of this partnership is the process of involving experienced resources, working in tandem with the client’s regulatory team and specialized in delivering multiple documents in expedited timelines.

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