The European Commission’s Medical Device Coordination Group (MDCG) last week published a new guidance with Q&A on obligations and related rules for the registration in EUDAMED of actors not subject to registration requirements under the Art. 31 Medical Device Regulation (MDR) and Art. 28 In Vitro Diagnostic Regulation (IVDR). These rules apply also to manufacturers of custom-made and legacy devices.
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Under new Regulations, actors other than manufacturers, authorized representatives and importers are required to register as actors in EUDAMED. Registration procedures are expected to be laid out in an upcoming Commission Implementing Regulation.
🔸 Difference between issuing an Actor ID and SRN number
Actor ID is applied to all actors in EUDAMED for their identification and is generated automatically when the registration is approved by the relevant competent authority. In contrast, the SRN is assigned in EUDAMED specifically to manufacturers, authorized representatives and importers by a competent authority.
🔸 Manufacturers of only custom-made devices
Manufacturers who only produce custom-made devices are exempted from registry requirements before placing their devices on the market. However, to enter information on class III custom-made implantable devices and to report serious incidents, field safety corrective actions, filed safety notices and any trends of non-serious incidents, manufacturers of custom-made devices will need to register as actors in EUDAMED. Also all non-EU manufacturers of only custom-made devices and their authorized representatives are required to register.
🔸 Manufacturers and authorized representatives of only legacy devices
Manufacturers of only legacy devices must register as actors in EUDAMED within six months of the date of publication of the notice under Article 34(3) of MDR announcing the functionality of EUDAMED. This requirement affects non-EU manufacturers and their authorized representatives, who will be assigned an Actor ID that is not an SRN.
🔸 Manufacturers of only “old” devices, which are made available on the Union market and/or are still in use
Manufacturers of “old” devices, which include devices placed on the market prior to, or according to, the medical device and in vitro diagnostic directives, will need to register in EUDAMED to submit reports of serious incidents or FSCAs. This duty also applies to non-EU manufacturers and authorized representatives. However, inactive manufacturers and authorized representatives of old devices are not subject to EUDAMED registration requirements.
🔸 System and procedure pack producers (SPPP)
The system and procedure pack producers (SPPPs) must register as an actor within six months of the notice announcing the functionality of EUDAMED, as they are obligated to assign a basic unique device identification-device identifier (UDI-DI) to be provided to the UDI database.
For more details, please see the MDCG Guidance.
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