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.
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.
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