Post-market surveillance and PMCF

Post-market surveillance and post-market performance follow-up (PMCF)

Post market surveillance is a crucial part of the medical device lifecycle and is emphasized in both EU MDR 2017/745 and IVDR 2017/746.

The manufacturer’s Post Market Surveillance (PMS) system must proactively and systematically gather, record and analyze relevant data on the quality, performance, and safety of the medical device throughout its entire lifetime. As a Manufacturer you are obliged to collect and assess relevant information not only about your own device but also related devices from competitors.

We can compile the PMS Plan, carry out the scheduled activities and produce the PMS Report or Periodic Safety Update Report (PSUR). We monitor subsequent updates to device technical documentation, risk management, and labelling.

Post-Market Clinical Follow-up (PMCF) and Post-Market Performance Follow-up (PMPF)

A key piece of the PMS is also the Post-Market Clinical Follow-up (PMCF) for MDs and the Post-Market Performance Follow-up (PMPF) for IVDs, where manufacturers must systematically record and evaluate clinical data regarding the safety and performance of their device.

We can compile the PMCF or PMPF plan, perform the activities as scheduled, analyze and report the findings, support you in implementing any preventive or corrective measures, and update the clinical evaluation plan/report. When required for your implantable or Class III medical device, we draw up and update the Summary of Safety and Clinical Performance (SSCP). Global Registrations

We help streamline your market access.

Every medical device (MD and IVD) needs to be registered in a regulatory area or country before it can be sold. Each location has its own requirements and procedures: The EU has a different process than the US FDA and even within the EU, some medical devices need local acceptance. We have registered low and high-risk medical devices in the EU and in more than 60 countries worldwide.