Medical Device Regulation (MDR) in the EU

The Medical Device Regulation (MDR), which came into force on May 27, 2021, changed the requirements for manufacturers that supply medical devices to the market in the EU.

The goal of the new regulation is to increase the quality and traceability of medical devices.

Accordingly, 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.

 “As a specialist supplier of connectors for medical applications, ODU supports our customers with complete technical documentation, providing certified qualification and validation information in compliance with DIN EN 13485:2016,” said Mathias Wuttke, business development manager for the Medical Technology Division.

This includes product information in the form of technical data sheets, test reports, and labelling of products or units.

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

Additionally, in the event of any alteration to products that require a new risk analysis ODU communicates relevant changes to its customers.

“For this purpose, we have set up a dedicated office within the company to provide specific information in response to manufacturers’ inquiries.” said Mathias.

www.odu-uk.co.uk

 

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