Hi,
MDR, art. 16, 2 states:
2. For the purposes of point (c) of paragraph 1, the following shall not be considered to be a modification of a device that could affect its compliance with the applicable requirements:
(b) 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.
So, your case study seems to be considered as repackaging but not as a repackaging affecting the device compliance to MDR.
However, it appears the point 4 of article 16 applies:
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, attesting that the quality management system of the distributer or importer complies with the requirements laid down in paragraph 3.
So, my additional questions, using your first example:
Case study: A distributor purchases syringes from a manufacturer. The syringes come in boxes that contain 100pcs (secondary package). A pharmacy orders to the distributor 20pcs. The distributor takes 20pcs from the box of 100pcs and puts them in another box to send the order to the pharmacy.
- distributors shall inform the manufacturer and the authority EACH time they perform this activity (for each order they receive from a pharmacy? for each LOT received by manufacturer?)
- distributors need to have their quality system certificated for this process, even if this process cannot affect the compliance of the device to MDR?
