Clinical Evaluation and Support with Notified Body Observations for an Emergency-Use Medical Device
Project Summary:
Manufacturers of a Class IIb emergency-use medical device required support in addressing observations from their Notified Body. The scope of work included advisory consulting for EU MDR compliance and medical writing support for Quality and Regulatory documentation.
Celegence Solution & Approach:
Celegence supported the RA/QA authority of the medical device manufacturing company in the following activities:
- Remediation of CEP, CER, and LSR to address gaps observed in Round 2 NB review.
- Gap assessment of IFU, Labelling, and Packaging against EU MDR and requirements of applicable standards.
- Remediation of IFU content for EU MDR compliance.
- Creation of Biological Evaluation Plan and Report with literature review to support biocompatibility of incorporated materials.
- Creating a PMS Plan.
- Defining a user-based PMCF Survey strategy and creating PMCF Plan with a scientific Likert-scale based questionnaire.
- Creation of Procedure documents for PMS, PMCF, and Clinical Evaluation.
- Creation of MDR-compliant templates for CEP, CER, PMS Plan, PMCF Plan, PMSR/PSUR, and PMCF Evaluation Report.
- Advisory consulting support on RA/QMS requirements.
Project Achievements
- Celegence team worked closely with their RA/QA authority to complete the scope of work for timely submission to the Notified Body.
- The NB observations were successfully addressed; the medical device is on its way to receiving initial CE marking under EU MDR.
- Appreciation received from the customer for the support provided by Celegence, for adapting to their requirements, and for highlighting critical gaps in their processes and documentation.
Project Outcomes
Key to the success of this partnership was a highly adaptable team of specialists who worked in tandem with the client’s team and experts who understood the gaps in the documents and were able to suggest practical solutions to meet regulatory requirements and NB expectations.
