Post Market Clinical Feedback Life Cycle
Post-Market Surveillance Feedback for Wound Dressings
Under the new Medical Devices Regulation (MDR), specifically Annex XIV, Part B, manufacturers are now required to establish and maintain a Post-Market Surveillance (PMS) system for each medical device. This system must be continuously updated based on the device’s risk classification and type.
The MDR places increased importance on post-market surveillance, including proactive monitoring of device performance for recertification, annual safety updates for high-risk devices, and swift incident reporting.
A PSUR (Periodic Safety Update Report) is a key requirement under the European Medical Device Regulation (MDR 2017/745), aimed at ensuring the continued safety and performance of medical devices throughout their lifecycle. It is primarily focused on post-market surveillance and risk management.
What is a PSUR?
A PSUR is a document that manufacturers of medical devices are required to compile and submit regularly.
It provides an ongoing assessment of the benefit-risk profile of a device by gathering data from the field and post-market activities. The PSUR helps in identifying trends, emerging risks, and any necessary corrective actions for ensuring the safety and effectiveness of the medical device.
User Surveys
User surveys are a key part of the PMCF plan and under MDD equivalence data is not permitted.
PMCF Plan
Your PMCF is only as good as the device specific data obtained from the market.
Frequency of PSUR Submission
The Challenge: Whilst in-house Regulatory & QA Departments are well versed in handling the constant stream of MDR hurdles facing them, one key problem still remains, collecting product relevant feedback from the professionals that use their devices.
Collecting clinical feedback in the wound care industry is notoriously challenging.
Complex Supply Chains
Limited Direct Clinician Engagement
Regulatory Burden and Compliance Requirements
Our Solution: To overcome these challenges, Med Dev Services has partnered with Wound Care People, a leading medical education provider in the wound care sector, to introduce Post Market Insights™. This comprehensive Post-Market Clinical Feedback (PMCF) service delivers brand specific post-market surveillance data, helping our clients stay compliant with MDR requirements.
Company Number 15734676
©Copyright. All rights reserved.
We need your consent to load the translations
We use a third-party service to translate the website content that may collect data about your activity. Please review the details in the privacy policy and accept the service to view the translations.