On 27 November 2019, the Medicines and Medical Devices Agency (“Agency”) published an announcement on a registration obligation for medical devices sold with pharmaceuticals. The announcement is prepared by the Agency’s Medical Device Registry and Coordination Department which deals with registry and monitoring of the medical devices by Product Tracking System (“UTS”).
Medical device notification procedures, product movements and other related works and transactions are monitored through the UTS. The registry and monitoring of pharmaceuticals are made through the Pharmaceutical Tracking System (“ITS”). Therefore, medical devices sold with pharmaceuticals are not individually registered to any system and the Agency considered that an arrangement is necessary in some cases for the registry of medical devices sold with pharmaceuticals in order to be able to track these medical devices.
Pursuant to the announcement, in cases where a reference to a medical device is made in the SmPC or PIL of a pharmaceutical, the manufacturer/importer of the pharmaceutical shall be registered as medical device sales center and responsible for the UTS registration and notification of the mentioned medical device. On the other hand, for medical devices which are available within the package of the pharmaceutical but no reference is made within the SmPC or PIL, no additional UTS registration or notification process is required. The relevant registration shall be made by the manufacturer or importer of the medical device.
A distinction has been made between medical devices which are sold with the pharmaceutical but are not referred in the SmPC or PIL of the product and the ones which are referred in the SmPC or PIL. However it is not clear why the pharmaceutical company should be registered as medical device sales centre and responsible for the UTS registration in case there is a reference to the medical device in the SmPC or PIL and why such obligation is not introduced when the medical device is simply available within the packaging but no reference is made in the SmPC or PIL.
The announcement creates a new burden on pharmaceutical companies whose pharmaceuticals already obtained the marketing authorization and their SmPC or PIL are approved simply because the registration of medical devices are made from a different system.
This obligation is now in force as of the publication of the announcement. The comments and objections of the industry on the imposition of this obligation is yet to be seen.