On 21st October 2021, the Medical Device Coordination Group (MDCG) published two important documents on the European Regulation on medical devices (MDR). The first refers to the requirements to be adopted by commercial operators of legacy devices while the second clarifies some common doubts about repackaging and relabelling activities under art. 16 MDR.

It is worth highlighting now the answers given by the MDCG to the questions that arose in connection with these repackaging and labelling activities. Let’s outline them briefly below.

  • Do the obligations related to repackaging and labelling apply only to importers and distributors or also to other parties?

Article 16(2), (3) and (4) only applies to importers and distributors. In particular, it does not apply to health care institutions or hospitals that divide a pack of devices into smaller packs or individual units to use or to be circulated within the health care institution/hospital.

  • Do Article 16 (3) and (4) of the MDR apply to legacy devices?

No, they do not. However, should the distributor or importer wish to do so, it is not forbidden.

  • Art. 16 para. 2 speaks of the necessity of repackaging and the necessity of additional information. When does this 'necessity' exist?

When a Member State has obligations that must be fulfilled in order to market the device in its territory. The analysis, however, has to be done on a case-by-case basis, checking whether there are, for example, national language requirements for the instructions on the device or the need to provide in a new package, a specific number of devices different from the one provided in the original packaging by the manufacturer. This is for the following reasons:

  • provide the health care system with packaging adapted to the needs of health care institutions in that specific Member State;
  • national practices authorising only a certain size of packaging;
  • health insurance rules that make reimbursement of medical expenses dependent on pack size;
  • well-established prescription practices.

It may be useful to review the ECJ judgments ECJ case Pharmacia & Upjohn SA v. Paranova (C-379/97), ECJ Servoprax Gmbh v Roche Diagnostics Deutschland Gmbh (C-277/15) and ECJ Lohmann & Rauscher International Gmbh & Co. KG v BIOS Medical Services Gmbh (C-662/15).

  • A single container arrives with a large number of devices inside. If you decide to split it into packages or individual units, do you fall under Art. 16?

No, provided that the outer packaging of the device (the one intended by the manufacturer) is not modified (e.g. maintaining the sterile state of a device). Example: syringes that are received in large packages in a shipping container, subsequently divided into smaller packages (e.g. sales packages consisting of individual units) to be supplied to vaccination centres and general practitioners. Art. 16 applies if the pack intended by the manufacturer is changed.

  • What information must be notified to the manufacturer 28 days before placing on the market?

Article 16 does not go into detail. The Q&A states that to enable effective field safety corrective action (FSCA) and post-market surveillance (PMS) by the manufacturer, it seems advisable to report:

  • name of the device in question and information allowing its unique identification: model, product number, reference or UDI-DI etc;
  • activities carried out (repackaging, relabelling and/or translation);
  • the reason why the activity carried out was considered necessary;
  • Member States where the repackaged/re-labelled and/or translated IFUs will be made available;
  • in case of translation, the languages in which the label and the IFU are translated;
  • the changes to the packaging and the number of devices included in the new packaging;
  • when the device is expected to be made available;
  • information about the notified body issuing the certificate in accordance with Article 16(4) and a copy of the certificate.

 

  • What information must be notified to the competent authority 28 days before placing on the market?

The Q&A suggest communicating:

  • the manufacturer's and authorised representative's details (if applicable);
  • name of the device in question and information that allows the device to be uniquely identified: model, product number, reference or UDI-DI, etc.; and
  • activities carried out (repackaging, re-labelling and/or translation);
  • the reason why the activity performed was deemed necessary;
  • in case of translation, the languages in which the label and the IFU are translated;
  • the changes to the packaging and the number of devices included in the new packaging;
  • when the device is expected to be made available.

 

  • Must the manufacturer and the competent authority be informed each time an individual device or lot of devices is relabelled or repackaged?

Only the first time. Notification does not have to be repeated unit by unit or lot by lot.

  • In what other cases should the manufacturer and the competent authority be notified?

As regards the manufacturer when:

  • a device is intended to be made available in a Member State not previously notified;
  • re-labelling and/or re-packaging will be applied to a device not previously notified;
  • the information supplied with the device will be translated into a language not previously notified.

As regards the competent authority when:

  • relabelling and/or repackaging will be applied to a device not previously notified;
  • the information supplied with the device will be translated into a language not previously notified;
  • the information supplied with the device or the outer packaging will be changed;
  • there are changes to the certificate issued by the notified body (including renewal of the certificate);
  • there is a change of notified body.

 

  • Should the manufacturer and the competent authority be informed when an importer or distributor stops relabelling and/or repackaging activities?

This is not foreseen in the MDR. It may be appropriate in relation to FSCA processes.

  • Which notified bodies can importers and distributors apply to in order to obtain the certification referred to in Article 16(4)?

To a notified body designated for the type of devices subject to the repackaging and relabelling activities (check on NANDO).

  • Does Article 16 also apply to Class I and Class A IVDs?

Yes, as there is no express exemption.

  • Can the importer or distributor provide additional information on the lot number while carrying out relabelling and/or repackaging activities?

The manufacturer's lot number may not be changed and must appear on the label. However, the importer or distributor may provide additional information for clarity (e.g. the sub-lot number of relabelled or repackaged devices or other information to ensure traceability of such devices).

  • If the IFU is translated, is it necessary to keep the original version of these instructions in the packaging?

There is no specific provision in the MDR, but the MDCG considers that the original version of these instructions may be included in the pack. Of course, the translated IFU should always be an accurate translation of the original version provided by the device manufacturer.

  • Does the entity that relabels and/or repackages have obligations regarding traceability and unique device identification (UDI)?

Importers and distributors performing relabelling and/or repackaging activities should implement solutions to meet the traceability requirements outlined in Article 25 MDR/Article 22 IVDR. They should also verify the allocation of UDI as set out in Articles 13(2)(d) and 14(2)(d) of the Regulations respectively.

In addition, importers and distributors are subject to the obligations of Article 27(8) MDR/Article 24(8) IVDR regarding the obligation to retain UDIs for devices that they have supplied or that have been supplied to them. This obligation applies to class III implantable devices and to devices, categories or groups of devices established by the measures referred to in Article 27(8).