June 30, 2021
The European Medical Device Coordination Group (MDCG) has issued a new Q&A document addressing Eudamed medical device and IVD database registration requirements for entities other than manufacturers, Authorized Representatives and importers, whose Eudamed registration rules are spelled out under the Medical Devices Regulation (MDR) and In-vitro Medical Devices Regulation (IVDR).
According to the new document, actors that do not qualify as device manufacturers, Authorized Representatives or device importers according to the new Regulations may not be subject to MDR Article 31 or Article 28 of the IVDR regarding Eudamed registration; MDCG covers eight questions regarding pertinent Eudamed registration obligations for actors including:
- Manufacturers of only custom-made devices
- Manufacturers of only legacy devices
- Manufacturers of only “old” devices
- System and procedure pack producers (SPPP)
General Eudamed registration procedure guidelines still to come
First, MDCG notes that a forthcoming Commission Implementing Regulation still being prepared by European Commissioners will cover procedures whereby all actors including those not subject to MDR Article 31 MDR or Article 28 IVDR will register under Eudamed.
Eudamed actor registration requests from manufacturers, Authorized Representatives, importers and SPPP will require verification and approval by Competent Authorities.
Actors falling outside the scope of Article 31 MDR or Article 28 IVDR should nonetheless pay close attention to MDCG information in the document on Eudamed registration requests related to first-time reporting of serious incidents or field safety corrective actions (FSCA), which entail data reporting obligations both to Eudamed as well as Competent Authorities.
Eudamed registration for only custom-made device manufacturers
Although only custom-made device manufacturers are not required to register as actors in Eudamed before placing their devices on the European market, Notified Bodies of Class III custom-made implantable devices must provide CE Marking certification data to Eudamed under the MDR.
In addition, any only custom-made device manufacturer will be obligated to submit reports of serious incidents, FSCA information and related safety and vigilance data to Eudamed.
Only legacy device registration requirements
Manufacturers of only legacy devices will be required to submit actor registration requests to Eudamed, and should prepare accordingly to meet these obligations.
Only “old” device registration in Eudamed
“Old” device companies whose products are either made available or still in use in Europe will have to register as actors in the Eudamed database, as well. These obligations have been established in the event that an EU member state requests submission of FSCA or serious incident reports involving these devices into Eudamed.
Registration considerations for SPPPs
Regarding system and procedure pack producers, Article 29 (2) MDR sets Unique Device Identification (UDI) requirements for these products that necessitate actor registration in Eudamed prior to placing them on the European market.