Importers and distributors may have the obligations of manufacturers in accordance with Article 16 MDR in certain cases. This is the case, for instance, when a distributor or importer makes a medical device available on the market under its own name, changes the intended purpose of the medical device, or makes other changes to the device that could affect its compliance with applicable legal requirements. For details, see our previous news.
Article 16(2) MDR specifies the cases in which certain activities of importers and distributors are not considered to be changes to a device within the meaning of Article 16(1)© that could affect the compliance of the device with the applicable requirements. In such cases, importers and distributors do not assume the manufacturer’s obligations.
These cases involve:
- (a) provision of information, translation of the information provided by the manufacturer, including the instructions for use (IFU), necessary for placing the device on the market in the Member State (relabeling).
- (b) changes to the outer packaging of a device already placed on the market which are necessary for placing the device on the market in the Member State concerned (repackaging).
The importers and distributors referred to in Article 16(2) are subject to obligations different from than those of the manufacturer described in Article 16(3) and (4) MDR.
Guidance document MDCG 2021–26
The MDCG 2021–26 Guidance Document (PDF) addresses relevant aspects for the economic operators carrying out any of the activities referred to in Article 16(2)(a) and (b) of the Regulations, i.e. relabeling and/or repackaging of devices.
It provides assistance and answers to the following questions:
- Do Articles 16(2), (3) and (43) apply only to importers and distributors or also to “other natural or legal persons” as mentioned in Article 16(1)?
- Do Article 16(3) and (4) MDR apply to “legacy devices”?
- For the activities referred to in Article 16(2)(a) and (b), what is meant by ‘necessary to market the device’ in the Member State question?
- Does the division of large quantities of devices in shipping containers into smaller quantities of devices in packages or individual units fall under Article 16(2)?
- What information should be provided to the manufacturer pursuant to Article 16(4)?
- What information is must be reported to the competent authority pursuant to Article 16(4)?
- Must the manufacturer and the competent authority be notified each time an individual device or batch of devices is relabeled or repackaged?
- Under what conditions should a notification sent to the manufacturer and the competent authority be carried out?
- Must the manufacturer and the competent authority be notified when an importer or distributor stops relabeling and/or repackaging?
- What notified bodies can importers and distributors turn to for the
- certification pursuant to Article 16(4)?
- Is relabeling and/or repackaging of Class I and Class A in vitro diagnostic medical devices also subject to review by a notified body as defined in Article 16(4)?
- Can the importer or distributor provide additional batch number information while relabeling and/or repackaging?
- If the instructions for use are translated, is it necessary to keep the original version of the instructions for use in the packaging?
- Do jobs that require relabeling and/or repackaging activities pursuant to
- Article 16(2) of the Regulation, comply with any obligations regarding traceability and unique device identification (UDI11)?
Practical use of the Guidance Document and recommended action
From this, it can be seen that the MDCG already addresses in great detail potential comprehension problems and any issues in light of Article 16 MDR. For importers and distributors, the MDCG’s recommendations should therefore be a valuable aid in positioning themselves to be MDR-compliant.
Nevertheless, it remains essential to carefully check the specific relabeling or repackaging for MDR compliance on a case-by-case basis. Ultimately, this is the only way to prevent the respective process from (unintentionally) resulting in manufacturer obligations and the associated liability risks for the importer or distributor.back