Preparing for the EU MDR transition
Due to the pandemic, the EU MDR (European Medical Device Regulations) will now be enforced on 26th of May 2021. Our clients are preparing for these updates, ensuring their devices and processes meet the new regulations. Utilizing our global medical device and combination product expertise, Worrell is continuing to support clients with the following MDR updates:
Human Factors Gap Analysis and Remediation Work
Our human factors team can help by conducting a gap analysis to determine whether both current and existing devices meet the relevant clauses of the MDR. Following the analysis and also review of all applicable risk management documentation, Worrell will create and implement a focused usability plan to ensure all relevant clauses are met. This work can range from a usability file review or full usability plan to implement further formative and summative evaluations.
Post Market Surveillance
With the expectations of post market surveillance increasing within the MDR, Worrell can assist in advising and composing post market surveillance plans. Once a plan has been created, our team of human factors engineers and researchers are able to collect the appropriate data to meet the current regulations. Some examples of these methods are shown below:
- Literature Reviews of Articles and Publications – related to safety & performance
- Device Complaint Reports (including Adverse Events)
- Risk Analysis
- Device Trend Reports
- Field Research and Focus Groups with End Users
- Expert Feedback with Clinical Specialists
The data collected will be consolidated into a report. This is expected to be a proactive and continuous process.
Documentation for Post Market Surveillance – Periodic Safety Update Report (PSUR):
Using the data captured as part of Post Market Surveillance, our team will help with the fabrication of the Periodic Safety Update Report (PSUR). This report will summarize the research findings and conclusions. It will provide a thorough analysis of the data and what actions (if any) need to be taken moving forward. It’s important to take a continuous and proactive approach throughout the post market phase, as expected by the MDR regulations.