Post Market Insights.
Our solution to your wound care Post-Market Surveillance challenge
Under the EU Medical Device Regulation (MDR 2017/745), Annex XIV, Part B, manufacturers must establish and maintain a comprehensive Post-Market Surveillance (PMS) system for every device they place on the market.
This is not a one-time compliance task but a continuous process, proportionate to the device’s risk class and intended use, designed to ensure that the clinical evidence and safety profile remain current throughout the product lifecycle.
At MDS, we recognise that PMS has evolved far beyond a regulatory obligation. It is now a strategic necessity, a mechanism not only to demonstrate ongoing safety and performance, but also to safeguard commercial viability in a changing healthcare landscape.
Why It Matters More Than Ever
The MDR has set a new standard for vigilance, requiring manufacturers to proactively gather and assess real-world evidence to support:
Recertification under MDR
Annual safety updates for Class III and implantable devices (via PSURs)
Ongoing trend analysis and timely incident reporting
However, regulatory compliance is only part of the picture. In the UK, the Department of Health’s Part IX Review of the Drug Tariff is introducing tighter evidence requirements for maintaining or securing reimbursement listings.
Manufacturers of wound dressings and related products will increasingly need to demonstrate clinical value, cost-effectiveness, and real-world outcomes to protect existing listings and justify continued NHS inclusion.
The convergence of these regulatory and reimbursement pressures means that effective PMS is now integral to both market access and market retention. Real-world data collection is no longer optional, it is the foundation upon which continued commercial success depends.
How MDS Can Help?
At MDS, we design and deliver tailored PMS programmes that meet both regulatory and market needs. Our expertise includes developing UK-based post-market studies that not only satisfy MDR requirements but can also generate the clinical, safety, and health economic evidence increasingly required to support reimbursement, formulary retention, and strategic market positioning.
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.
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.
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.
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.
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 legal manufacturers are audit-ready and compliant with PMS and PMCF requirements