The MDR brings more stringent requirements for manufacturers seeking approval or certification. The aim is to minimize risks and enhance patient safety throughout the device's lifecycle.
Maria Duguine, Ph. D., EU/UK Consultant
Companies marketing implantable medical devices in the EU have had to adjust to increased scrutiny and a stricter approval process in recent years. In guiding our clients through the evolving guidelines, we have come up with a couple overarching suggestions.
The EU's Medical Device Regulation (MDR) introduced stricter rules around clinical evidence, with manufacturers required to provide more robust data to support their products. There are also stricter rules around the classification of devices, with some products that were previously considered low risk now being subject to more stringent regulations.
For implantable medical devices, there are some major changes under MDR to consider.
RQMIS has identified the following areas:
The Shift Toward a Higher Threshold of Evidence
Clinical Studies and Notified Body Oversight
Notified bodies are now demanding more robust clinical data, even for lower-risk devices. The emphasis is on obtaining solid evidence of the device's safety, performance, and long-term outcomes.
Extended Timelines
Manufacturers need to allocate additional time and resources to gather sufficient clinical evidence, conduct studies, and navigate the regulatory review process.
Enhanced Safety and Patient Outcomes
The increased scrutiny and emphasis on clinical evidence help identify potential risks early on, ensuring that only safe and effective devices reach the market.
RQMIS Support
Are you a medical device manufacturer looking for a reliable and experienced partner to navigate the complexities of the Notified Body process? Look no further! RQMIS is here to support and guide you every step of the way, from technical documentation development to audit readiness and submission to your Notified Body. Contact RQMIS to begin the process today.
