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Home | Newsletter | UPDATE 1 | 2017 | MDR UDI - the EU Follows Suit
April 5, 2017

MDR UDI — the EU Follows Suit What European manufacturers need to know about the new regulations

The level of public confidence in the safety of medical products has suffered in the recent past. Following the PIP scandal, news about battery failure in implants, faulty electrodes and shifting prostheses abounded. The new EU Medical Device Regulation (MDR) is intended to reassure consumers and increase the safety of patients and traceability of products.

The mandatory labeling of medical products with a UDI (Unique Device Identification) code constitutes a completely new requirement within the EU. The FDA already passed a corresponding act for the US market in 2013, which also applies to European manufacturers exporting to the United States.

 

MDR UDI (Medical Device Regulation)

Graph: The new MDR will take effect in May 2017. Manufactures will be granted a transitional period of three years.

 

An old hat?

Is compliance with the MDR UDI regulations an old hat to companies who have been exporting to the US since 2013? “Far from it”, says Katharina Gimbel, Compliance Expert at ARCONDIS. There are considerable differences between the two sets of UDI regulations, and the devil is, as they say, in the detail.

Comparison of FDA UDI and MDR UDI

Download comparison of the key elements of FDA UDI vs. MDR UDI

 

An upstream gap analysis conducted by an expert who is familiar with both regulations can save an immense amount of resources for companies who already comply with FDA UDI. “UDI newbies” will have to get busy implementing the new standards and consult professional help, if necessary. After all, first experiences with UDI compliance have already been made elsewhere, and what could be a better source of wisdom than the mistakes of others?

Katharina Gimbel

 

Companies that are already working in compliance with FDA UDI regulations will not have to reinvent the wheel, but they should not be lulled into a false sense of security by their FDA compliance, either – the FDA regulations are not always stricter than their EU counterparts.”

— Katharina Gimbel, Senior Consultant at ARCONDIS Group


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