EU clarifies Eudamed rules for legacy and custom-made devices

Dive Brief:

The EU's Medical Device Coordination Group has posted guidance on how requirements related to the Eudamed database apply to products not subject to the new regulations.
Eudamed was developed to support the Medical Device and In Vitro Diagnostic Regulations. However, MDR and IVDR lack explicit explanations of how Eudamed applies to products placed on the European Union market under other regulatory frameworks.
MDCG, which advises the European Commission, has moved to clarify the situation through a question and answer document that details the Eudamed requirements for legacy, old and custom-made devices, as well as for system and procedure pack producers (SPPPs).

Dive Insight:

MDCG acknowledged the need for additional information on the Eudamed requirements for certain devices in 2019, when it said MDR "is not explicit" in requiring that legacy devices are subject to the unique device identification rules. In response, MDCG said legacy devices, the term for products that come to market under the old directives in the grace period, should be registered in Eudamed.

Now, MDCG has provided more information on legacy devices and other products that are placed on the market under regulatory frameworks other than MDR and IVDR. The document confirms that the manufacturers of legacy devices need to register as actors in Eudamed.

MDCG also used the question and answer document to clarify the rules on devices that were placed on the market before the date of application for MDR or IVDR and are made available in the EU or still in use. Companies that only manufacture such products, referred to by MDCG as old devices, will have to register as actors in Eudamed to report serious incidents and field safety corrective actions. The requirement applies to the authorized representatives of companies based outside of the EU.

Given the age of the medical devices involved, it is possible that the manufacturers and authorized representatives of some of the products will no longer be active. In that scenario, MDCG said serious incidents and field safety corrective actions will go unreported in Eudamed.

Two other questions addressed by MDCG relate to custom-made devices. Manufacturers of such devices are exempt from the requirement to register as actors in Eudamed before placing a product on the market. However, MDR requires notified bodies to enter information about the certificates of custom-made devices in Eudamed and manufacturers need to report serious incidents, field safety corrective actions and any trend on non-serious incidents.

As such, MDCG is asking manufacturers of custom-made devices to register as actors before their notified body enters information about the first certificate for their Class III product and before they submit their first vigilance reports. The requirements apply to the authorized representatives of manufacturers based outside of the EU.

SPPPs are the final group covered by the guidance. As MDCG explains, MDR obligates them to assign a Basic UDI-DI to the database before placing a system on the market. The obligation means that SPPPs need to register as actors in Eudamed.