The Medical Device Regulation (MDR) presents new challenges for many companies in the medical technology sector. While a company’s role in the regulatory context is decisive, implementation remains demanding.
At Entrhal Medical, we operate as an importer and distributor of medical devices. Our regulatory obligations are clearly defined by this role. Nevertheless, the MDR has a significant impact on our Quality Management System (QMS).
In an interview with our colleague Marcela Garcia de Guzicki (Head of QA/RA, QMR), we provide insights into how we implement MDR requirements pragmatically and collaboratively.
Our Role in the Regulatory Context
As an importer and distributor, our responsibilities are clearly defined. Still, MDR compliance requires structured integration into existing processes.
“Entrhal’s role in the regulatory context is that of an importer and distributor of medical devices. Our obligations are limited to these roles. Nevertheless, the impact on the QMS is demanding.”
A stable and trustful relationship with our suppliers is essential.
“We manage this through good business relationships with our suppliers. Transparent communication is the key to successful cooperation.”
Adjustments in Quality Management
To remain MDR-compliant, the following processes were refined:
- Customer feedback
- Complaint management
- Post-Market Surveillance (PMS)
These areas are now closely interconnected and systematically documented. The goal is not only to meet regulatory requirements but also to achieve genuine product improvements.
Efficiency Despite Increased Documentation
MDR introduces higher documentation requirements. For us, this means processes must remain clear, lean, and traceable.
“Processes must remain lean. Wherever possible, they should be digitalized or automated.”
Digitalization and structured workflows help us balance efficiency and compliance.
Cooperation with Notified Bodies
MDR intentionally leaves room for interpretation, making coordination necessary.
“A regulation cannot cover every specific area. Therefore, there are still uncertainties between companies and Notified Bodies, but good communication simplifies cooperation.”
Open communication, careful preparation, and clear documentation are key.
Customer Feedback as a Regulatory Responsibility
Customer feedback and PMS data are an integral part of our QMS.
“We collect and process them together with our suppliers. This approach enables product improvements and ensures compliance with regulatory requirements.”
As a link between manufacturers and users, this feedback loop is crucial.
Advice for Other Companies
Marcela Garcia de Guzicki offers a key piece of advice:
“First, MDR requirements must be understood and communicated internally. All employees involved in MDR certification must be included. Only then can a structured plan be developed and implemented.”
Quality is not a solo task. It is teamwork and the responsibility of every employee, not just the QMB or PRRC.
Conclusion:
MDR sets clear requirements – even for importers and distributors. With transparent processes, close supplier collaboration, and structured quality management, regulatory requirements can be implemented efficiently and sustainably.
