The European Union's Medical Device Coordination Group (MDCG) published two texts Monday to help companies comply with incoming regulations.
MDCG created the guidelines to explain how device makers can register legacy medical devices in the European Database on Medical Devices (Eudamed) and the timeline for registering data elements in the database.
The guidelines are intended to resolve gaps and inconsistencies in the EU medical device and in vitro diagnostic rules, such as the confusion over the deadline for registering products.
The adoption of the industry-changing EU regulations on medical devices and IVDs in 2017 marked the end of one process and the start of another. The texts created new frameworks for the regulation of medical devices and IVDs in the EU but left many of the specifics unresolved. It is the job of MDCG, a group of experts convened by the European Commission, to iron out the details.
With the device regulations set to come into force next year, MDCG clarified two outstanding areas of uncertainty this week. The publications center on the Eudamed database that will aid enforcement of the safety and performance requirements of the incoming regulations.
The legislation requires manufacturers to assign all devices, with the exception of custom products, a unique identifier and provide it to a centralized database before bringing them to market. However, different parts of the text refer to different deadlines, leading MDCG to conclude that the rules are inconsistent.
MDCG has ruled that the longer, 18-month transitional period will be the standard timeline, meaning companies have until late 2021 to register unique identifiers and other data elements associated with their devices. If the Eudamed introduction is delayed, companies will have a further six months.
The second document published by MDCG clears up a question about how the registration rules will apply to devices that came to market under the old regulations. The incoming regulations permit the continued sale of these devices under certain conditions, including that they are registered in line with rules. However, the regulations make no explicit reference to the need for device identifiers.
Given Eudamed is designed to house registration information about devices with unique identifiers, the rules on legacy devices create a problem for the database. MDCG plans to resolve the issue by adapting Eudamed to permit the registration of devices without unique identifiers.
The MDCG guidelines clear up some of the uncertainty about the medical device and IVD regulations but with a little more than one year to go until many of the changes take effect there is still plenty of work to do. Many of the implementing acts intended to make the rules work are due to be published just months before the device regulation comes into force.