New Q&A from the EU Commission Addresses the Role of Device Importers
Summary: Revision 1 of the guidance (MDCG 2021013 Rev.1) has an additional Q&A (#9):
Question: Do importers who carry out the activities mentioned in Article 16 MDR/IVDR also need to register as manufacturers in EUDAMED?
Answer
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Importers who assume the obligations required on device manufacturers must register in EUDAMED, the European Databank on Medical Devices
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However, importers conducting activities as set in Article 16(2) of the new Medical Device Regulation (EU 2017/746) are not required to register in EUDAMED as manufacturers since these activities are not considered a modification of a device that could affect its compliance with the applicable requirements
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Article 16(2) states that a company is not a legal manufacturer if it:
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translates the instructions for use/labeling of a device already a Prescription Only Medicine, or
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Re-boxes a non-sterile product (doing that for a sterile product is deemed to “[modify] a device already placed on the market or put into service in such a way that compliance with the applicable requirements may be affected” and hence they would become the legal manufacturer per Art 16.1).
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Importers are subject to the obligation of registering as Importers in EUDAMED in accordance with Article 31 MDR as the importer places the device on the EU market
However, further clarity is sought with respect to Article 16, namely:
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If the MAH/importer was to split a bulk pack of sterile devices, is the original condition of the device is adversely affected?
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If splitting the bulk pack is necessary, how is this addressed in the Quality Management System of the MAH/importer placing the drug-device combination on the EU market?
Industry associations have given their thoughts in a reflection paper on Article 16 – ‘Cases, in which obligations of manufacturers apply to importers, distributers or other persons.' Clarification will be sought from the EMA Quality Working Party.
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