Case Study: Clinical Evaluation of Dental Diagnostic and Therapeutic Devices

Background – Client Needs:

Celegence is providing support to several manufacturers of dental consumable materials, dental equipment, and dental imaging devices and software in authoring CEP, CER, PMSR/PSUR, and SSCPs.

Deliverables included: templates, Clinical Evaluation Report, Literature Review Report, PMSR/PSUR, SSCP for new devices to be launched on the market as well as legacy devices.

Project Initiation & Key Objectives:

The scope of Celegence activities was to create end-to-end documentation. This included creation of the Clinical Evaluation Plans including detailed search strategies for searching device-specific literature on scientific databases and adverse events on safety databases, and a robust state-of-the-art review to complement the gathered evidence.

The team was expected to summarize all manufacturer-held data, including claims, non-clinical tests, clinical investigations, and Post-Market Surveillance data. All of the gathered evidence was to be analysed and the findings from the clinical evaluation were to be used to demonstrate conformity to the relevant General Safety and Performance Requirements.

Celegence Solution & Approach:

Celegence supported the manufacturers for the following activities for their Class I, IIa, and IIb devices:

  • Authoring Clinical Evaluation Plans (CEPs) and Clinical Evaluation Reports (CERs) in compliance with EU/MDR 2017/745. 

  • Authoring Post Marketing Surveillance Reports (PMSRs), Periodic Safety Update Reports (PSURs), and Summary of Safety & Clinical Performance (SSCP) Report in accordance with EU/MDR 2017/745.

  • Assess adequacy of clinical data based on product history, pre-clinical and clinical studies, complaints, adverse events, and literature. 

Project Achievements

Based on the quality of deliverables, the scope of work was expanded to include additional documentation.

Celegence continues to deliver high-quality regulatory documentation via an end-to-end process involving the right stakeholders to achieve:

  • > 98% quality & timeline delivery performance, an achievement in collaborating with Celegence’s expertise
  • Improved compliance based on guidance from Celegence’s regulatory experts

  • 80% of documents approved at first draft stage

Project Outcomes

Celegence continues to provide support in creation of regulatory documentation to various dental device manufacturers.

The key to the success of this partnership is the involvement of regulatory experts and implementation of quality control measures for each deliverable. Furthermore, nuanced understanding of regulations resulted in faster turnaround time and minimal review comments (0 – 1 review cycle only).

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