Repackaging and making of translations
A distributor, importer or other natural or legal person shall assume the obligations incumbent on manufacturers if it does any of the following:
- makes available on the market a device under its name, registered trade name or registered trade mark;
- changes the intended purpose of a device already placed on the market or put into service;
- modifies a device already placed on the market or put into service in such a way that compliance with the applicable requirements may be affected.
Provision, including translation, of the information supplied by the manufacturer relating to a device already placed on the market and of further information which is necessary in order to market the device in the relevant Member State shall not be considered as a modification of a device.
Changes to the outer packaging and pack size of a device are possible if the original condition of the device is not affected. In the case of sterile devices in particular, attention shall be paid to the packaging layer that is necessary for maintaining the sterile condition, the opening of which is considered to have an adverse effect on the original condition of the device.
If the distributor repackages or modifies the device, it shall indicate the activity carried out on the device or device packaging. In addition, the distributor shall indicate its name, registered trade name or registered trade mark, registered place of business and the address at which it can be contacted, so that its location can be established.
Distributors and importers shall ensure that they have a quality management system in place which includes procedures for ensuring that the translation of information is accurate and up-to-date, the original condition of the device is preserved, and the packaging of the repackaged device is not defective, of poor quality or untidy.
The quality management system shall cover, inter alia, procedures ensuring that the distributor or importer is informed of any corrective action taken by the manufacturer in relation to the device in question in order to respond to safety issues or to bring it into conformity with this Regulation.
The operator shall, at least 28 days prior to making the relabelled or repackaged device available on the market:
- inform the manufacturer and the national competent authority of the intention to make the relabelled or repackaged device available;
- upon request, provide the manufacturer and the competent authority with a sample or mock-up of the relabelled or repackaged device, including any translated label and instructions for use;
- submit to the competent authority a certificate, issued by a notified body, attesting that the quality management system complies with the requirements imposed on it.