Post Market Insights our solution to your Post Market Surveillance challenge
Post-Market Surveillance
A Strategic Imperative in the Evolving Wound Care Landscape
Under the EU Medical Device Regulation (MDR 2017/745), particularly Annex XIV, Part B, manufacturers are required to implement and maintain a robust Post-Market Surveillance (PMS) system for every medical device.
This is not a one-off exercise but an ongoing process tailored to the risk classification and intended use of the device, aimed at continuously updating the clinical evidence and safety profile throughout the product lifecycle.
At MDS, we recognise that post-market surveillance is no longer just a regulatory box-ticking exercise. It has become a critical tool for demonstrating continued safety, performance, and cost-effectiveness, especially as market access requirements grow more demanding.
Why It Matters Now More Than Ever
The MDR has raised the bar significantly, placing increased emphasis on proactive monitoring. Manufacturers must now generate real-world evidence to support:
- Recertification under MDR
- Annual safety updates for Class III and implantable devices (via PSURs)
- Timely incident reporting and trend analysis
But regulation is only part of the story. The UK reimbursement environment is also shifting. The Part IX Drug Tariff Review, which governs the inclusion and pricing of wound dressings and related products in the NHS supply chain, will bring tighter scrutiny on clinical value, cost-effectiveness, and real-world outcomes.
As these two forces converge, manufacturers need to prepare for a future where continued market access depends on real-world evidence generation, not just clinical trial data.
What is a PSUR?
A Periodic Safety Update Report (PSUR) is a core deliverable within the PMS framework for higher-risk devices. Required under MDR, a PSUR offers a structured, ongoing evaluation of the device’s benefit-risk profile by:
- Aggregating and analysing post-market data
- Identifying emerging trends and safety signals
- Recommending any needed corrective or preventive actions (CAPAs)
At MDS, we support medical device companies in developing tailored PMS strategies, including the design and execution of UK-based studies that not only fulfil MDR obligations but also generate the kind of health economic and clinical data increasingly required for reimbursement and formulary retention.
Post Market Clinical Feedback Life Cycle
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
- Class IIa and IIb devices: A PSUR must be updated at least every two years.
- Class III and implantable devices: The PSUR must be updated and submitted to the Notified Body annually.
Post Market Surveillance Feedback for Wound Dressings
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
- Indirect Distribution Channels: Wound dressings are often sold through distributors, wholesalers, and various intermediaries before reaching the end user (clinicians or healthcare facilities).
- Fragmented Feedback Sources: Feedback can come from multiple, non-standardised sources, including hospitals, clinics, home care services, and even patients, complicating efforts to consolidate and analyse the data efficiently.
Limited Direct Clinician Engagement
- Lack of Direct Access to Clinicians: Regulatory teams often have limited direct engagement with the clinicians using the products, frequently the task is delegated to the not always co-operative sales team.
- Feedback Delays: Clinicians may only report issues when there is a significant problem, resulting in a lack of real-time feedback on product effectiveness or minor but recurring issues. Minor incidents may go unreported if they are seen as common or insignificant by clinicians, despite being critical for regulatory surveillance.
Regulatory Burden and Compliance Requirements
- High Volume of Data: Regulatory requirements such as the MDR necessitate continuous and comprehensive data collection. Keeping up with these requirements, particularly for high-risk devices, can be overwhelming for manufacturers.
- Data Integration: Compiling data from diverse sources into a format that meets the stringent requirements for post-market surveillance can be time-consuming and resource-intensive.
- Data Privacy Concerns: Navigating data protection regulations (e.g., GDPR) may also complicate the collection and sharing of patient-specific feedback.
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.
Targeted feedback on your device
Post Market Insights™
- Designed specifically to meet the regulatory demands of MDR audits
- Helps collect, analyse, and report clinical data for regulatory submissions
- Ensures manufacturers are audit-ready and compliant with PMS and PMCF requirements