In June 2021, the Medical Device Coordination Group (MDCG) published the Q&A Guide to answer some of the most significant questions related to the registration in EUDAMED of actors who aren’t considered Manufacturers, Authorised Representatives and Importers, the rules on whose registration in the Eudamed database are defined by the MDR (EU) 2017/745 and the IVDR (EU) Regulations 2017/746.
According to the document, actors who do not qualify as Manufacturers, Authorised Representatives or Importers of Medical Devices, according to the new regulations, may not be subject to Art. 31 of the MDR or Art. 28 of the IVDR in regard to the registration in EUDAMED.
The questions and answers in the MDCG 2021-13 rev. 1 mainly concern the EUDAMED registration requirements for Manufacturers of:
- Custom-made devices:
- Legacy devices only. Devices defined as such are Medical Devices, Active Implantable Medical Devices and Medical-Diagnostic In Vitro Devices which are covered by a valid certificate in accordance with Directives 93/42/EEC (MDD), 90/385/EEC (AIMDD) or 98/79/EC (IVDD) and which continue to be legally on the market after the date of application of the MDR (EU) 2017/745 (26 May 2021) and IVDR (EU) 2017/746;
- Only “old devices”, MDD devices that are still available on the market, but do not fall within the grace period. Example: Class I MDD;
- Procedural systems and kits (SPPPs)
In July 2021 the document was re-released to provide clarifications on the registration of Importers carrying out activities which fall under Art. 16 MDR/IVDR “Cases where manufacturers’ obligations apply to importers, distributors or other persons.”
According to Art. 16, paragraph 1, an Importer assumes the obligations of the Manufacturer in relation to certain cases such as:
- If changes are made to the intended use of a device already placed on the market or put into service;
- If changes are made to a device already placed on the market or put into service in such a way that its compliance with the applicable requirements may be affected.
In such cases, Importers are obliged to register as Manufacturers in EUDAMED.
Whereas, Importers carrying out the activities referred to in Article 16, paragraph 2, are not obliged to register as Manufacturers in EUDAMED, because such activities are not considered modifications of a device that would compromise its compliance with the applicable requirements.
General guidelines on the EUDAMED registration procedure currently under preparation
With the guideline MDCG informs that an Implementing Regulation by the European Commission is being prepared, a Regulation on the procedures according to which all actors, including those not subject to Art. 31 of the MDR or Art. 28 of IVDR, will register under EUDAMED.
Actors who do not fall within the scope of Art. 31 of the MDR or Art. 28 of the IVDR should however pay attention to the information contained in the MDCG document on requests for registration related to the reporting of major accidents or corrective actions in regards to safety on the field (FSCA), which entail an obligation to provide information on the specific cases to both EUDAMED and Competent Authorities.
Actor Identification (Actor ID) and Single Registration Number (SRN)
The guidelines also provide clarification on the definitions of Actor Identification (Actor ID) and Single Registration Number (SRN).
“Actor ID” is defined as “the identifier issued to all actors registered in EUDAMED for their identification in the system. It shall be generated automatically by EUDAMED and issued once the application for registration has been approved by the relevant Competent Authority.”
While a Single Registration Number (SRN) is defined as the number “which is issued through EUDAMED to Manufacturers, Authorised Representatives and Importers by the Competent Authority in accordance with Art. 31 of the MDR and Art. 28 of the IVDR.”
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MDCG 2021-13 rev.1 Questions and answers on obligations and related rules for the registration in EUDAMED of actors other than manufacturers, authorised representatives and importers subject to the obligations of Article 31 MDR and Article 28 IVDR, MDCG, july 2021