Switzerland (Head Quarters)

IDR Medical Switzerland
Austrasse 95, CH-4051 Basel, Switzerland
T: +41 (0) 61 535 1109

UK

IDR Medical UK
Unit 104 Eagle Tower, Eagle Tower
Montpellier Drive, Cheltenham, GL50 1TA
T: +44 (0) 1242 696 790

USA

IDR Medical North America
225 Franklin Street, 26th Floor
Boston, Massachusetts 02110, USA
T: +1 (0) 617.275.4465

The Challenge

A leading wound care manufacturer was preparing to launch a new Negative Pressure Wound Therapy (NPWT) system into global markets. Regulatory success depended on one critical factor: Level 8 Post-Market Clinical Follow-up (PMCF) data under EU MDR.

They needed robust, real-world evidence showing how the system performed in everyday clinical use — not just in one region, but across Europe, North America, and Asia.

The challenge was significant:

  • Nine countries with different healthcare systems and regulatory environments

  • Time-poor clinicians

  • A fixed MDR timeline with no room for slippage

Failure to deliver consistent, compliant data across all markets would put both regulatory approval and commercial launch at risk.

 

Our Approach

1. Regulatory-Aligned Study Design

We designed a PMCF programme built specifically to meet MDR Level 8 requirements, ensuring that all data collected would be usable in the client’s regulatory submission.

The framework was aligned to:

  • Real-world clinical use

  • Safety and usability outcomes

  • GDPR and data-privacy requirements

2. Global, Localised Execution

We developed a concise, 20-minute online survey optimised for busy wound care clinicians and deployed it across nine countries.

The programme was:

  • Localised – translated and culturally adapted for each market

  • Targeted – restricted to HCPs with direct experience of the NPWT system

  • Compliant – fully anonymised, GDPR-aligned, and audit-ready

Wound care nurses, physicians, and specialist clinicians were recruited through established local networks to ensure speed and data quality.

3. Central Control, Local Delivery

A single, centrally governed framework ensured consistency across countries, while local field teams handled recruitment and language adaptation — allowing the study to move quickly without sacrificing regulatory rigour.

 

Deliverables

The project delivered:

  • A multi-country MDR-compliant PMCF dataset

  • Real-world evidence on use, safety, and usability

  • Consistent, structured data across nine markets

  • Documentation ready for direct integration into the client’s MDR submission

 

Impact

This project enabled the client to meet a critical regulatory milestone without compromising on data quality or timelines.

By combining global coordination with local execution, we helped the manufacturer:

  • Complete PMCF on time and in scope

  • Engage clinicians across multiple healthcare systems

  • Secure a high-quality evidence base to support their MDR filing

  • De-risk the commercial launch of their new NPWT system

The result was regulatory progress, commercial confidence, and a clear pathway to market — proving that even complex, multi-country PMCF programmes can be delivered efficiently, at scale, and with full compliance.