When you fill out the email subscription form to the right, you will receive a confirmation email. Once you confirm your subscription, you will receive an automated email with the attached PMS plan template. For each of your CE Marked products or product families you need to create a customized PMS plan. The template instructs you to define roles and responsibilities for gathering post-market information, defines the inputs to gather and defines the frequency for summarizing your results.
PMS plan template content
- Responsibilities & Authorities
- PMS Inputs
- Data Summary
- Discussion of Data
- Training of Personnel
- Documents and Records
Click here you are looking for a procedure about post-market surveillance. The procedure instructs you to create a unique post-market surveillance plan for each product or product family. The PMS plan is created during the design transfer process and approved as part of the final design review when a new product is launched. The plan should also include an updated risk management plan in order to specify how post-production data collection will be conducted in compliance with ISO 14971:2007, Clause 9.
There is also a webinar on the topic of post-market surveillance (PMS) and post-market clinical follow-up (PMCF) study requirements for CE Marking. The webinar explains why the there is an increased scrutiny of PMS data and how this will impact the CE Marking process in the future. One of the significant changes is that the content of a technical file will now be required to include a post-market surveillance section that includes a PMCF protocol and report.
Click Here or the Image Below for Rob Packard’s Webinars