FAQ on the repackaging of face masks for resale
1. Can I repackage masks if agreed with the manufacturer?
Yes, this is a possibility if the distributor has agreed with the manufacturer to repackage the products under the responsibility and supervision of the manufacturer. If requested by the competent supervision authority, you must therefore be able to provide written confirmation from the manufacturer that the repackaging has taken place under their supervision and in compliance with their quality management system.
2. Can I repackage masks into smaller units and sell them without an agreement with the manufacturer?
No. The Danish executive order on medical devices stipulates that the manufacturer is responsible for the construction, manufacturing, packaging and labelling of medical face masks.
It is therefore the manufacturer who decides the pack size of the face masks. Thus, it is also the manufacturer who ensures that the face masks are packed according to a relevant quality standard, and that they are labelled correctly and with sufficient information for the end user.
This ensures that face masks are supplied to end users in such a condition that they are not contaminated, damaged or otherwise deteriorated. It also ensures that face masks are supplied with product-specific details and enables the traceability of the product to the manufacturer (for example by way of product identification and a lot or a batch number).
In case the manufacturer’s packaging is changed afterwards by other actors in the supply chain, without the involvement of the manufacturer, there is a risk that the manufacturer’s quality standards no longer apply, and the manufacturer can therefore not be held accountable for incidents resulting from other actors’ handling of the product. During repackaging of a product, there is a risk of product deterioration, contamination or damage to such extent that the face mask no longer has the intended effect.
3. Can I repackage the device if I take responsibility for the device?
Yes. The starting point is that if an actor changes the manufacturer’s construction, manufacturing, packaging and labelling, that actor takes over the manufacturer’s responsibility and must meet the requirements for medical devices, including the requirement for keeping the full technical documentation of the device's development, manufacturing, labelling, control, release, storage, etc.
4. I do not wish to take over the manufacturer’s responsibility, nor does the manufacturer want to be responsible for my repackaging. Can I apply for an exemption from repackaging?
Yes. The changes to executive order no. 1211 of 16 August 2020 permits the Danish Medicines Agency in exceptional circumstances to grant an exemption from repackaging of non-sterile masks intended for resale in order to deal with acute public supply shortages. Exemptions are given temporarily to applicants in the event that increasing demand is causing acute local or regional supply shortages of face masks. To ensure continued traceability, it is a requirement that the number of end users can delimited. However, if the distributor affixes a CE mark to the new package, this is a violation of EU regulations, as CE marking is reserved for manufacturers (or a representative of the manufacturer) The mask’s intended purpose must therefore be changed to a non-medical device, and the CE mark must be removed.
5. What details should the application for exemption include, should I wish to apply for an exemption from repackaging?
An application for exemption from repackaging without prior agreement with the manufacturer should be submitted to the Medical Devices unit. The application must include a filled in application – see Appendix A below.
6. What are the requirements regarding the physical conditions of repackaging?
Regardless of whether the repackaging takes place in collaboration with the manufacturer or pursuant to an exemption from the Danish Medicines Agency, a number of minimum requirements must be met:
- Control of contamination from
o Employee – the person repackaging the product must have clean hands.
o Production environment
o New packaging materials
- Preservation of traceabilit
o Lot/batch number
o Expiry date – either relative (a time period in relation to the time of manufacture) or absolute (a date)
o Traceability to employee (and machine as relevant) in the repackaging process
o Stock management
- The packaging’s protective effect, e.g.
o Physical protection
Link to Appendix A – application for exemption from repackaging of surgical face masks (PDF)
To be submitted to the Danish Medicines Agency Medical Devices unit on this email.