MDCG Q&A on EUDAMED Actor registration for legacy & custom-made device manufacturers, SPPP

The MDCG has released a Questions & Answers document clarifying actor registration obligations in accordance with MDR Article 31 and IVDR Article 28. Some terms, such as Actor ID, SRN, Legacy devices and ”Old” devices are also explained.

The document is particularly relevant for:

  • Legacy device manufacturers
  • Custom-made device manufacturers
  • Manufacturers of ”old” devices [MDD/IVD compliant devices placed on the market before MDR/IVDR date of application]
  • System and procedure pack producers [SPPP]

Below, some important questions and answers from the most recent MDCG document:

When do manufacturers of only custommade devices have to register as actors in EUDAMED?

Articles 52(8), 56(1) and (5) MDR require notified bodies to enter the information regarding the certificates issued for class III custommade implantable devices in EUDAMED. Moreover, manufacturers shall report in EUDAMED serious incidents, field safety corrective actions and their related field safety notices (Article 87 MDR), any trend on non-serious incidents (Article 88 MDR) for custom-made devices. Therefore, manufacturers of only custom-made devices have to register as actors in EUDAMED in the following cases:

  • in advance of the entering of the information in EUDAMED by the notified body regarding the first certificate for their Class III custom-made implantable device;
  • they submit to EUDAMED for the first time vigilance reports for serious incidents, field safety corrective actions with their field safety notices, or trend reports in respect of custom-made devices of any risk class;

The registration as actors in EUDAMED will be required, in the abovementioned cases, also for non-EU manufacturers of only custom-made devices and the authorised representatives for the concerned custom-made devices.

Registered manufacturers and authorised representatives of only custom-made devices are assigned an Actor ID that is not a SRN.

Do manufacturers of only legacy devices have to register as actors in EUDAMED?

Yes, manufacturers of only legacy devices6will have to register as actors in EUDAMED. According to Article 123 (3) (d) MDR and Article 113 (3) (f) IVDR, the deadline for such registration is 6 months after the date of publication of the notice referred to in Article 34 (3) MDR. Member states may accept/require the use of EUDAMED for the purpose of registration in accordance with national rules, during the transition period. The obligation to register as actors in EUDAMED is applicable also to nonEU manufacturers and authorised representatives of only legacy devices.

Registered manufacturers and authorised representatives of only legacy devices are assigned an Actor ID that is not a SRN.

Do manufacturers of only ‘old’ devices have to register as actors in EUDAMED?

Yes, manufacturers of only ‘old’ devices, which are made available on the Union market and/or are still in use, will have to register as actors in EUDAMED in case serious incidents reports or field safety corrective actions in respect of the device are requested by the Member States to be reported in EUDAMED. The obligation to register as actors in EUDAMED is applicable also, in the abovementioned cases, to nonEU manufacturers of only ‘old’ devices and their concerned authorised representatives. In case either the manufacturer or the authorised representative is not active anymore, serious incidents and the field safety corrective actions will not be reported in EUDAMED and the manufacturer or authorised representative will not have to register as actor in EUDAMED.

Registered manufacturers and authorised representatives of only old devices are assigned an Actor ID that is not a SRN.

Do system and procedure pack producers (SPPP) have to register as actors in EUDAMED?

According to Article 29 (2) MDR, before placing a system or procedure pack on the market, the natural or legal person responsible (SPPP) has an obligation to assign a Basic UDIDI to be provided to the UDI database, together with the other data referred to in Part B of Annex VI MDR. In order to fulfil such obligation, as from 6 months after the date of publication of the notice referred to in Article 34 (3) MDR, the SPPP will have to be registered as actor in EUDAMED before placing a system or procedure pack on the market. Member states may accept/require the use of EUDAMED for the purpose of registration in accordance with national rules, during the transition period.

Registered SPPPs are assigned an Actor ID that is not a SRN.

 

Discover MDCG replies to the rest of the questions, by clicking here:

  • What is the procedure to register as actor in EUDAMED?
  • Who is the authority responsible for the approval of actor registration requests of SPPP located in nonEU countries?
  • When the Actor ID may be considered as a Single Registration Number (SRN) pursuant to Article 31 MDR and Article 28 IVDR?
  • Do manufacturers of only custommade devices have to register as actors in EUDAMED?

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