25 May 2022

Increasing the quality and traceability of medical devices

The MDR requires medical device manufacturers to meet all relevant regulatory requirements

ODU is a specialist supplier of connectors for medical applications. Connectors, cables, and housings for diagnostics, therapy, or monitoring are parts of medical devices and, as preliminary products, must comply with the requirements of the Medical Device Regulation (MDR).

The MDR came into force in May 2021 and changed the requirements for manufacturers that place medical devices on the market in the EU. The goal of the new regulation is to increase the quality and traceability of medical devices. Accordingly, it influences the processes involved in manufacturing these products and entails additional testing and documentation.

Mathias Wuttke, Business Development Manager for the Medical Technology Division says: “To support our customers with complete technical documentation, we provide certified qualification and validation information in compliance with DIN EN 13485:2016. This includes product information in the form of technical data sheets, test reports, and labelling of products or units.

“Furthermore, as an ODU company, we pay attention to product-related topics such as patient and user protection, and implement them in compliance with IEC60601-1. We can also implement Unique Device Identification (UDI) by laser marking our connectors.”

Wuttke continues: “In addition, we communicate relevant changes to our customers in the event of alterations to products that require a new risk analysis. For this purpose, we have set up a dedicated office within the company to provide specific information in response to manufacturers’ inquiries.”

With the aim of ensuring flawless medical devices that increase both patient and user safety, the MDR requires medical device manufacturers to meet all relevant regulatory requirements before they can bring their product to market. In this context, the requirements refer to the medical device itself; for example, the inclusion of accompanying information and instructions for users. In addition, the technical documentation, classification, approvals, and other issues must all be ensured.

 

Company info: ODU