MDCG 2021-26

Given that Article 16(3) sets out requirements for importers and distributors and in doing so, cross-references activities performed in points (a) and (b) of Article 16(2), it is considered that Article 16(2), (3) and (4) apply only to importers and distributors.
It is noted that Article 16 (2), (3) and (4) do not apply in cases where a health institution or hospital splits up a large pack of devices, which they have received, into smaller pack sizes or individual units for use or circulation within the health institution/hospital. In this example, the activities are not performed in order to market the devices in the relevant Member state, and are therefore not within the scope of Article 16 (2), (3) and (4).

* See footnote (3).

No, Article 16(3) and (4) of the MDR do not apply to ‘legacy devices’. However, this is without prejudice to the possibility for economic operators to follow any MDR requirements also for ‘legacy devices’, especially if they deal with both ‘legacy devices’ and MDR devices and want to apply the same procedures for all devices.

‘Necessary in order to market’ refers to conditions that should be met in order to market the device in that Member State. Whether a relabelling or repackaging activity is necessary, should be analysed on a case-by-case basis.
Examples of the abovementioned conditions may include (non-exhaustive list):

• national language requirements for device information supplied by the manufacturer;
• the need to supply in a new package, a specific number of devices different from the number of devices supplied in the original packaging by the manufacturer, for reasons of:
  • providing the healthcare system with pack sizes that are suitable for the needs of health institutions in that Member state;
  • national practices authorising only a certain packaging size;
  • health insurance rules making the reimbursement of medical expenses dependent on the size of the packaging;
  • well-established medical prescription practices.

It is not a “relabelling” or “repackaging” activity within the meaning of Article 16(2), if the importer or distributor is simply splitting-up larger quantities of devices (for example in a shipping container) into smaller quantities (for example packages, lots or individual units) for further supply in the distribution chain, including to the final user, provided that the outer packaging (5) of the device in question is not affected (e.g. maintaining in particular, a device’s sterile condition). Such splitting-up of packages is a common wholesale or retail practice and is not considered to fall within the scope of Article 16(2) of the Regulations.

An example of this is a distributor that buys syringes in large quantities, which are received in large pack sizes in a shipping container. The distributor then splits up the large packs into smaller quantities (e.g. sales packages consisting of individual units) in order to provide them to vaccination centres and general practitioners.

The general obligations of distributors laid down in Article 14 of the Regulations also apply, which include verification that the devices they make available are CE marked and are accompanied by the information to be supplied by the manufacturer (such as the label and IFU).

In accordance with Article 16(4), importers and distributors performing relabelling and/or repackaging activities should:

• inform the manufacturers of the intention to make the relabelled or repackaged device available on the market, at least 28 days prior to making the device available on the market and;
• upon request, provide the manufacturer with a sample or mock-up of the relabelled or repackaged device, including any translated label and IFU;

While this is not a requirement for importers and distributors under the Regulations, they may provide information in order to allow for effective field safety corrective actions (FSCA) and post-market surveillance (PMS) by the manufacturer. This may include (non-exhaustive list):

• name of the concerned device and information allowing for the unambiguous identification of the device: model, product number, reference or UDI-DI etc.;
• activities performed (repackaging, relabelling and/or translation);
• the reason why the activity performed is needed;
• Member States where the repackaged/relabelled and/or translated IFU devices will be made available;
• in case of translation, languages in which the label and IFU (6) are translated;
• the changes to the package and number of devices included in the new packaging;
• when the device is planned to be made available;
• information on the notified body issuing the certificate in accordance with Article 16(4) and a copy of the certificate.

In accordance with Article 16(4) of the Regulations, importers and distributors performing relabelling and/or repackaging activities, at least 28 days prior making the device available on the market, should:

• inform the competent authority (of the Member State where they plan to make the device available) of the intention to make the relabelled or repackaged device available on the market, and;
• submit to the competent authority the necessary certificate as per Article 16(4) of the Regulations as described in MDCG 2021–23 (7).

Moreover, upon request, importers and distributors performing relabelling and/or repackaging activities should provide the competent authority with a sample or mock-up of the relabelled or repackaged device, including any translated label and instructions for use.
While it is not a requirement for importers and distributors under the Regulations, they may wish to further inform competent authorities about: (non-exhaustive list):

• manufacturer and authorised representative (if applicable) details;
• name of the concerned device and information allowing for the unambiguous identification of the device: model, product number, reference or UDI-DI etc.;
• activities performed (repackaging relabelling and/or translation);
• the reason why the activity carried out/performed is needed;
• in case of translation, languages in which the label and IFU (8) are translated;
• the changes to the package and number of devices included in the new packaging;
• when the device is planned to be made available.

There are no specific requirements in the Regulations.

However, it is considered that a notification to the manufacturer and relevant competent authority (of the Member state where the repackaged or relabelled device is intended to be made available), is only due when a device is going to be relabelled and/or repackaged for the first time. The notification does not have to be repeated on a unit-by-unit or batch-by-batch basis.

In accordance with Article 16(4), importers and distributors performing relabelling and/or repackaging activities should inform the manufacturer and competent authority (of the Member State where they plan to make the device available), of the intention to make the relabelled or repackaged device available on the market, at least 28 days prior.
A notification to the manufacturer should be performed when one or more of the following conditions occur (non-exhaustive list):

• when a device is planned to be made available in a Member State not previously notified;
• when relabelling and/or repackaging will be applied to a device not previously notified;
• when the information supplied with the device will be translated into a language not previously notified.

A notification to the concerned competent authority should be performed when one or more of the following conditions occur (non-exhaustive list):

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

Whilst this is not a requirement for importers and distributors under the Regulations, they may wish to inform the manufacturer and competent authority of the Member State concerned, of the cessation of their relabelling and/or repackaging activities. This information could be useful in relation to FSCA processes.

Importers and distributors have to apply to a notified body designated for the type of devices that are subject to activities mentioned in points (a) and (b) of Article 16(2) (9).

Importers and distributors can find the information regarding the type of devices for which notified body is designated by consulting the Nando (New Approach Notified and Designated Organisations) Information System. (10)

Since Class I devices are not explicitly exempted, Article 16(2) to (4) apply also in case of repackaging and/or relabelling of those devices.

The manufacturer’s batch number cannot be changed and should appear on the label.

However additional information can be provided by the importer or distributor for clarity e.g. the sub-lot number of the relabelled or repackaged devices or other information which ensures traceability of those devices.

Whilst there is no a specific requirement in the Regulations, in case of translation of the IFU, the original version of these instructions may be included in the packaging. The translated IFU should always be an exact translation of the original version provided by the manufacturer of the device.

Importers and distributors performing relabelling and/or repackaging activities should implement solutions to meet traceability obligations outlined in Article 25 MDR. They should also verify UDI (1) assignment as set out in Article 13(2)(d).

In addition, importers and distributors are subject to the Article 27(8) MDR obligations for economic operators to store UDIs for devices which they have supplied or which have been supplied to them. This requirement applies to the class III implantable devices referenced in Article 27(8) MDR.