Repackaging of a medical device or translated its labelling
The purpose of this article is to address the interpretation of the provisions in Article 16 of EU Regulation 2017/745. Recently, misinterpretations of the regulations contained in that Article have been voiced at medical device conferences. Our analysis and its outcome are consistent with the interpretation advocated by 27 notified bodies in the area of medical devices that take part in regular meetings of the Notified Body Group. It is not by chance the fact that those meetings are also attended by representatives of the European Commission.
The new EU Medical Device Regulation 2017/745, and specifically its Article 16 permits entities such as an importer, distributor or other person to provide translation of the information supplied with the device (and further information which is necessary in order to market the device in the relevant Member State) and device repackaging, without being considered to be the manufacturer of the medical device.
For device repackaging, this activity is permitted “if the repackaging is necessary in order to market the device in the relevant Member State and if it is carried out in such conditions that the original condition of the device cannot be affected by it.” “In the case of devices placed on the market in sterile condition, it shall be presumed that the original condition of the device is adversely affected if the packaging that is necessary for maintaining the sterile condition is opened, damaged or otherwise negatively affected by the repackaging.”
Unfortunately, undertaking any of the activities above gives rise to an obligation to meet quite restrictive legal requirements. An entity which performs those activities must be fully identifiable on the device packaging or in a document accompanying the device. In addition, such an entity is required to indicate on the device, where physically practicable, the activity the entity carried out (or otherwise the activity must be indicated on the device packaging or in the accompanying documents).
However, this is not the worst part from the distributors’ and importers’ perspective. Article 16.3 reads that distributors and importers shall ensure that they have in place a quality management system. That system must include procedures which ensure that the translation of information is accurate and up-to-date and, as regards repackaging, that the activities are performed “by means and under conditions that preserve the original condition of the device and that the packaging of the repackaged device is not defective, of poor quality or untidy.
Quality management system
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 implementation of an appropriate system requires more involvement than has ever been required before from importers or distributors.
An entity which performs any of the activities mentioned above is obliged to inform the manufacturer and the competent authority of the Member State in which they plan to make the device available of the intention to make the relabelled or repackaged device available (at least 28 days prior to making the device available on the market). Additionally, upon request from the manufacturer or the competent authority, those entities will provide a sample or mock-up of the relabelled or repackaged device, including any translated labels and instructions for use. However, the provision does not make it clear if the device manufacturer can object to the activities being carried out or if it has any obligations to ensure that these are properly performed. On the other hand, the regulation in Articles 13 and 14 obliges importers and distributors to work with the manufacturer on safety issues related to the device.
Importers and distributors are required to hold and provide to the competent authority, within 28 days prior to making the device that has been subject to the above activities available on the market, a certificate issued by a notified body designated for the relevant type of devices. That certificate will also serve as certification of conformity of the importer’s or distributor’s quality management system to the requirements set out in Article 16.3, i.e. a proof of accuracy and due care in the translation of the information and in the device repackaging.
The question is, alas, what certificate is meant here? Is it a certificate issued by a notified body to the manufacturer or a CE certificate of conformity but issued by a notified body to an importer or distributor? Eventually, the third option is that this is an ISO 13485 certificate. Despite the complex language of Article 16, the answer is quite simple. Notified bodies designated for the purposes of Regulation 2017/745 will be authorised to issue such certificates, however, an importer/distributor which provides the label translation or device repackaging must use a body whose designation makes them competent for the device which is subject to those activities. For instance, if you perform the repackaging of eye drops or contact lenses, you need to use a body which is competent to assess those device types.
The question remains how and what guidelines those bodies will use to assess if any of the activities above is performed in an appropriate manner. And there is no one answer to this question. Bodies can draw on their own past experience and develop own assessment criteria. Team-NB members are likely to develop common guidelines and the criteria to be applied by notified bodies might be based on the selected aspects of the EN ISO 13485 standard. However, it is quite improbable for notified bodies to build their assessment methods on the elements of “conformity assessments” provided in Annexes IX to XI to Regulation 2017/745 since the latter will focus on demonstrating the safety and efficacy of the medical device.