Post-market surveillance

PMS is a regulatory requirement for medical devices in Europe. The purpose of PMS is to ensure that the manufacturer has taken appropriate steps to ensure that their products are safe and effective. This includes ensuring that the product meets the required standards, as well as providing adequate training and support to healthcare professionals using the product.

Medical Device Manufacturers are required to have a Post Market Surveillance System (PMS). In Articles 85 and 86, the Post Market Surveillance reporting requirements have been described. According to Article 85, Manufacturers should produce a Post Market Surveillance Report for all lower-risk (Class I) devices. PMS should be updated on a regular basis. It is suggested that the manufacturer do this at least once every three years.

According to Article 86, Manufacturers are required to produce a Periodic Safety Update Report for all higher risk (Class IIa, IIb, and III) devices (PSUR). The PSUR for Class IIa, Class IIb, and class III devices must be produced and updated at least once a year. In addition, the amended PSUR for Class III devices must be submitted to the Notified Body via the EUDAMED database for review.

How can we help?

• We will help the manufacturers to develop the PMS plan. This involves determining whether Post-Market Clinical Follow-up (PMCF) is necessary.
• Helps you through the PMS activities.
• Helps to provide templates for PMS plans, procedures, and reports.
• Helps determine PMCF requirements based on PMS data.
• Analyses and generates valid conclusions from Post Market Surveillance Data.
  Contact us Today for more details.