Transparency Code Updates for Medical Device Companies in the Netherlands

By Benoit Racault

GMH, the Netherlands’ Medical Device Association, has issued an update to its code of conduct, with revisions regarding transparency reporting.

Article 22 of the code conveys a broadening of scope on the companies required to report. Previously, the code applied only to companies that supplied devices that are partially or totally implanted in the human body by an operative or medical method. This included ICDs, pacemakers, stents, hip and knee prostheses.

The new definition states that all suppliers of medical devices must report the data, regardless of the type of device provided. The scope has also been extended to include all recipients listed with a “doctors” specialty in the BIG Register database, as opposed to strictly cardiologists or orthopedists.

However, the transfer of values that must be reported are the same, with a threshold of all interactions exceeding 500€ per calendar year, as is the method in which companies submit reports.

The revised code of conduct went into effect on January 1st 2017, with a first disclosure for 2017 data due in March 2018.

For information on Polaris’ solutions and how they can help you stay compliant with this and all global regulations, contact us.