Post-Market Clinical Follow-up

Does your device already have CE approval?
We help you collect targeted clinical data about your medical device by means of proactive Post-Market Clinical Follow-up measures!

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CERES supports customers to plan and conduct Post-Market Clinical Follow-up for medical devices efficently.

Post-Market Clinical Follow-up (PMCF) is an essential part of Post Market Surveillance (PMS). According to MDR the manufacturer has to keep the clinical evaluations of the devices up-to-date. To fulfil manufacturers responsibility there are several opportunities to collect clinical data continuously:

Post-Market Clinical Follow-up study
Device Registry
PMCF Survey
Real-World Evidence
Literature research
Use of AE and complaint databases

Together, we determine appropriate PMCF measures according to relevant guidelines, e.g. MDCG 2020-7, as well as your individual needs.

CERES – full-service for PMCF investigations

We assist you to plan and design your PMCF study. We support your submission, can select your study sites, monitor the study, collect and analyse the clinical data, write the clinical study reports and even more. Thus, we can reliably handle your entire study or you can only use the services you currently need. Feel free to contact us while selecting the appropriate tasks from our full range service for clinical investigations.

In PMCF studies, devices are used within the scope of their intended use. Therefore, some tasks are not necessary for these studies. However, we will guide you safely through the different requirements from MDR and ISO 14155.

CERES provides the following Services

PMCF Plan

The planning ensures that manufacturers comply with the obligation of appropriate proactive market surveillance. Moreover, PMCF and PMS offers the opportunity to gain valuable information on product development, device and user behaviour, long-term experiences and customer satisfaction.

Justified selection of PMCF activities:
Which measures are appropriate depends on your medical device, its risk classification, the available clinical data and your goals.
Determine sources, amount and procedures

Research Service

We offer you reproducible research, addressing your product, equivalent devices, state of the art or treatment alternatives. Sources, search terms and time period will be justified or taken from your existing clinical evaluation.

Literature research
Database researches addressing (S)AE and complaints
– national

– EU

– global
Selection, analysis and evaluation

Real-World Evidence

Planned Real-World Evidence (RWE) from reliable data sources could be used and analysed within the PMCF. The Real-World Data (RWD) should be of sufficient quality. Objectives and amount to analyse data from RWE have to be specified in advance (MDCG 2020-7). E.g., the following data could be useful:

Retrospective data
Service data
Device records

PMCF Studies

PMCF studies can be e.g.

PMCF investigations, i.e., clinical investigations to further assess CE-market devices
Extended follow up of patients included in pre-market clinical investigations
Retrospective studies

In addition to the study design, information on the sample size, endpoints, inclusion/exclusion criteria, etc. are required in the synopsis (a summary of the clinical investigation plan). In particular for implantable devices and devices of class III, the PMCF study must confirm the safety and performance of the device, unless a clinical investigation according to MDR Art. 61 (4) has been carried out. (MDCG 2020-7)

We support you both in design and during implementation.

Reporting

PMCF report (MDCG 2020-8)
Updated clinical evaluation reports
PMS report for class I devices (MDR Art. 85)
Periodic Safety Update Report (PSUR) for class IIa, IIb and III devices (MDR Art. 86)
Summary of Safety and Clinical Performance (SSCP), mainly for implants and class III devices (MDR Art. 32 (1))
Clinical investigation report

Do you need more information? Feel free to contact us.