Clinical Evaluation for Emergency Use Device
MDR Support for Flow Monitoring Devices
Project Summary
A global manufacturer of flow monitoring systems and probes partnered with Celegence for end-to-end MDR regulatory support across its portfolio of Class III, Class IIb, and Class I devices used in ECMO, cardiovascular surgeries, dialysis, and other critical procedures. These devices provide indirect clinical benefits, making clinical evidence generation and endpoint identification particularly challenging. The engagement focused on annual maintenance, initial CE marking under MDR, development of PMS documentation and SOPs, technical file support, and Authorized Representative (AR) services.
Scope of Work
Celegence supported the client by:
Authoring PMS Plans, PMCF Plans and Reports, and PSURs.
Developing and implementing PMS SOPs to support systematic post-market activities and audit readiness.
Developing and implementing PMS SOPs to support systematic post-market activities and audit readiness.
Developing and implementing PMS SOPs to support systematic post-market activities and audit readiness.
Addressing Notified Body comments, resulting in reduced queries during subsequent review cycles.
Mapping extensive PMS data and literature to identify safety and performance trends and conduct risk analysis.
Identifying suitable similar devices to support equivalence-based justifications.
Identifying suitable similar devices to support equivalence-based justifications.
Outcome
Successful CE marking under MDR across multiple device risk classes.
Reduced Notified Body queries in subsequent review cycles through structured documentation and responses.
Identification of emerging risks leading to updates in risk files and IFUs.
Identification of emerging risks leading to updates in risk files and IFUs.
Project Success
The success of this engagement was driven by Celegence’s expertise in supporting devices with indirect clinical benefits, combined with strong collaboration across the client’s regulatory and cross-functional teams. A structured, data-driven approach enabled efficient management of large volumes of clinical and risk data while maintaining documentation quality and alignment with MDR expectations.
Highlights
MDR support for Class I, IIb, and III flow monitoring devices
PMS, PMCF, PSUR, and technical file support
Risk mapping and equivalence-based clinical justification
Software verification and validation documentation support
Reduced Notified Body queries and smoother review cycles
Successful MDD-to-MDR transition support
Need MDR Support for Complex or Indirect Benefit Devices?
Celegence provides end-to-end regulatory support, including PMS, PMCF, risk analysis, and technical documentation services to help manufacturers achieve MDR compliance efficiently. Email us at info@celegence.com
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22 Apr, 2026
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