CRO for PMCF - Post Market Clinical Follow-up

Your partner for clinical follow-up of medical devices

Continuous post-market clinical follow-up(PMCF) is known to be essential to ensure the safety and effectiveness of a product after market launch. PMCF studies are an integral part of Post-Market Surveillance (PMS) for medical devices and are even a mandatory part of quality management.

It is not always possible to rule out all risks during the approval process, which is why post-market surveillance is also important for your product. Even if these studies initially sound very time-consuming and like a lot of work, thanks to our help, conducting such a study will be the easiest thing in the world for you. We support you in the proactive collection and evaluation of clinical data after your product has been placed on the market and take as much work as possible off your hands in all areas – from planning to evaluation – so that you can concentrate on other things.

When are PMCF studies necessary and how are they designed?

Post-market clinical follow-up studies are necessary and mandatory as soon as a regular market observation cannot provide sufficient clinical data to carry out a mandatory update of the safety data.

The data obtained in these studies represent a subset of the total PMS data and thus supplement the data collected in other studies. PMCF studies are particularly important for novel medical devices or those that are clearly associated with an increased risk.

First of all, a PMCF plan must be drawn up for all PMCF studies, which defines exactly how the follow-up is to be carried out. In addition to the evaluation and observation of the company’s own product, similar products are also used to evaluate the data. The PMCF plan is a component of the Post Market Surveillance Plan (PMS plan).

Together with our sister company Medicoforum GmbH, we are experts in the field of conducting PMCF studies.

Our services in the area of PMCF

As a CRO with over 25 years of experience, we have regularly supported clients who wanted to carry out PMCF studies as efficiently and conscientiously as possible. Over the years, we have been able to develop concepts that enable us to offer individual and customized solutions for each client. With us you get:

Development of an individual PMCF plan under real application conditions
Advice and support for the successful implementation of the developed strategies
Creation of PMCF processes, plans and reports
Support with case number planning and evaluation of the generated data
Planning, implementation and supervision of your PMCF study (e.g. long-term observations of patients or studies on known risks from the literature)
Observational studies (under routine conditions)
Retrospective evaluation of existing user data
Monitoring the scientific literature
Evaluation of other PMS activities
Regulatory support from start to finish

MDR requirements for the data collected

The European Medical Device Regulation requires proactive, continuous, objective and thorough documentation and performance of clinical evaluations (Article 61; Clinical evaluation, Annex XIV; MDR). Furthermore, the manufacturer of a medical device is obliged to collect and regularly update the documentation and clinical data generated on the basis of the clinical follow-up plan over the entire life cycle of the device. Particular attention must be paid to this:

Data collection: Data on quality, safety, usability, justifiability of the risk-benefit ratio and performance of the product are collected. The data collected is used to identify necessary corrective measures and implement appropriate interventions.
Determining the scope according to the type of device: The scope and thoroughness of the assessment to be carried out will vary depending on the classification, intended purpose, type and risks of the device. For some devices, further clinical surveillance may not be considered necessary if sufficiently justified and documented.
Reporting obligations: PMCF activities make it possible to identify unknown side effects and contraindications as early as possible. Furthermore, systematic errors or applications outside of the approval can be identified and thus necessitate a re-evaluation of the intended use. Any safety corrective actions and incidents must be reported to the authorities immediately and investigated.

Place your trust in our expertise

Benefit from our team of experts and their many years of experience in conducting PMCF studies. With us, you get the complete package and we support you in all duties and activities of clinical follow-up – from the preparation of the plan to communication with the authorities in the event of necessary notifications – with us, your project will always be implemented in an uncomplicated and timely manner.