Under Article 16(4) of the MDR and IVDR, a distributor or an importer that relabels (translates) or repackages a device shall get their Quality Management System certified by a Notified Body:
4. At least 28 days prior to making the relabelled or repackaged device available on the market, distributors or importers carrying out any of the activities mentioned in points (a) and (b) of paragraph 2 shall 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 and, upon request, shall 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. Within the same period of 28 days, the distributor or importer shall submit to the competent authority a certificate, issued by a notified body designated for the type of devices that are subject to activities mentioned in points (a) and (b) of paragraph 2 [see below], attesting that the quality management system of the distributor or importer complies with the requirements laid down in paragraph 3.
provision, including translation, of the information supplied by the manufacturer, in accordance with Section 20 of Annex I, 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;
changes to the outer packaging of a device already placed on the market, including a change of pack size, 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.
As the activity of the notified body is not related to the conformity assessment procedures set out by the Regulations, there is need to further clarify the specific assessment activities under MDR/IVDR Article 16.
In this respect, the MDCG Guidance provides an overview of activities, requirements, auditing, surveillance and changes and minimum content of the Certificates issued by a notified body. As well as necessary elements that a QMS of an importer or distributor relabelling or repackaging a device should address. A more detailed Questions & Answers document will follow to address different requirements of economic operators in this aspect.
In accordance with the MDCG Guidance, the quality management system of importers or distributors – involved in Art. 16(3) activities – is expected to cover and address at least the following:
- Documentation of the management system, including responsibility of the management, and development of policies and procedures,
- Resource management, including premises and equipment necessary to carry out activities referred to in points (a) and (b) of Article 16(2) as well as selection and control of suppliers and sub–contractors,
- Policies for assignment of activities and responsibilities to personnel ensuring the availability of resources and information necessary to support the operation and monitoring of the activities mentioned,
- 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 the Regulation (Article 16 paragraph 2 points (a) and (b)),
- Management of corrective actions including procedures for handling non–conforming devices and market recalls due to the activities carried out under point (a) and (b) of Article 16(2), including, when necessary, field safety corrective actions and verification of their effectiveness,
- Procedures to ensure traceability of the devices as well as labels, instructions for use and outer packaging indicating the changes made to the product,
- Control of documents,
- Control of records,
- Supervision of the implementation and maintenance of the quality management system, including internal audits and management review.
Generally, the QMS should govern the structure, responsibilities, procedures, processes and management of the resources required to implement the principles and actions necessary to achieve compliance with the provisions of Article 16(3) of the MDR / IVDR.
The MDCG also emphasizes the importance of agreements between economic operators (and NB and economic operators) to ensure compliance with certain provisions of the Regulation:
- Contracts with any economic operator the distributor or importer is purchasing the device from should ensure that the distributor or importer is informed in a timely manner about 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 the Regulation;
- In addition, the contract between the notified body and the distributor or importer should specify the possibility for the notified body to perform on–site audits at the premises of the distributor and importer or their subcontractors if needed, as specified in section 6 of this document.
Notified bodies appointed to perform certification activities need to be designated for the type of devices subject to the activities mentioned in points (a) and (b) of Article 16(2) of the MDR and IVDR.
In case a distributor/importer plans to relabel and or repack new types of devices, they should verify that the notified body issuing the certificate is designated also for the new type(s). If this is not the case, they should apply to a notified body bearing the required designation.