Post Market Follow Up is a continuous process mandated by EU Regulation. Manufacturers must proactively collect and evaluate clinical data to confirm the device safety and performance. This must be done throughout the lifetime of the device and is a requirement for all medical devices.

What do you need to be compliant?

Post Market Surveillance (PMS) requirements for medical devices in the EU MDR require key components. These include post market plans, activities and reports and the continual process is known as post market clinical follow up (PMCF). This outlines the manufacturer’s responsibilities for collecting and evaluating clinical data in order to ensure the device’s safety and performance across its lifetime.

How can Clin-r+ help?

Our team of clinical affairs consultants, clinical trial designers, and biostatisticians makes sure that your future claims are cost-effectively incorporated into your PMCF studies in addition to addressing any clinical data gaps.

We work with manufacturers and put a plan in place to proactively gather, records and analyse their device performance and safety. There are several PMCF methods from Registries and Clinical Investigations to Surveys and Literature Searches. We work with our clients to identify what is right for them and set up systems to gather information and feedback that demonstrates continued performance and identifies any safety issues. Our team also has the expertise for calculating sample sizes for clinical investigations and PMCF studies.

CLIN-r+ has created MDR compliant PMCF plans for a variety of devices. We tailor these to each client to ensure a balanced approach and offer solutions for effective PMCF strategies and data capture. We assist with ensuring that PMS data is aligned with Risk Management and Clinical Evaluation. By supporting you to assess clinical and safety data, systems can be put in place to ensure PMCF documentation is kept compliant.

Need more details?

We are here to assist. Contact us, set up a meeting, join our mailing list or follow us on LinkedIn.

You can also check out these white papers on our MedTech Academy:

• Post Market Surveillance
• CER, SSCP and PSUR
• Summary of Safety and Clinical Performance (SSCP)
• Effective PMS
• Periodic Safety Update Report
• Post Market Clinical Follow Up (PMCF)