BRUSSELS, Belgium: Recently, there have been two policy and regulatory developments at EU level that are relevant for the activities of ADDE and its members, owing to the fact that they will have an impact daily on the activities of dental dealers within the EU. These are new rules for distributors regarding relabelling and repackaging, and a new EU legal framework for distribution agreements, as explained by the independent law firm contrast, which specialises in competition, EU, corporate and business law advice.
Regarding the new rules for distributors relating to relabelling and repackaging requirements, the Medical Device Coordination Group has published a guidance document on repackaging and relabelling activities under Article 16 of the Medical Device Regulation (MDR) and Article 16 of the In Vitro Diagnostic Medical Devices Regulation (IVDR).
Article 16 MDR/IVDR sets out when importers, distributors or other natural or legal persons must assume the obligations of manufacturers under the MDR and provides specific obligations for distributors or importers that carry out relabelling or repackaging activities.
Article 16(1) MDR/IVDR states that importers, distributors or other persons must assume the obligations of manufacturers when:
a) making a device available on the market under their own name, registered trade name or registered trademark, except in case of an agreement with a manufacturer whereby the manufacturer is identified on the label and is responsible for meeting the requirements for manufacturers under the MDR;
b) changing the intended purpose of a device already placed on the market or put into service; or
c) modifying a device already placed on the market or put into service in such a way that compliance with the applicable requirements may be affected.
Article 16(2) MDR/IVDR clarifies that certain activities are not considered as modifying a device in accordance with Article 16(1)(c). This includes relabelling the device (i.e. including information, such as a translation, which is necessary for marketing the device in a certain EU member state) and repackaging the device, provided that this is necessary and does not affect the original condition of the device.
Article 16(3) and (4) MDR/IVDR set out the obligations for importers or distributors that relabel or repackage devices in accordance with Article 16(2) MDR. The present guidance document takes the form of questions and answers and addresses the obligations imposed by Article 16(2)–(4) MDR/IVDR. Among other topics, the Q & A document addresses the following:
Question 3 clarifies what is meant by the requirement in Article 16(2) MDR that the relabelling or repackaging activities must be “necessary in order to market the device in the relevant member state”.
Question 4 explains that the mere splitting-up of large quantities of devices is not considered a relabelling or repackaging activity within the meaning of Article 16(2) MDR.
Questions 5 to 9 concern the obligation to notify the manufacturer and/or the competent authority.
Questions 10 and 11 concern the obligation to establish a quality management system and to have this system certified by a notified body. Question 11 clarifies that this requirement also applies to Class I devices.
A PDF copy of the guidance document can be accessed here.
New EU legal framework for distribution agreements
As ADDE members may know, the European competition rules relating to distribution, agency and supply agreement are about to change. The current legal framework will expire on 31 May 2022 and the European Commission has issued its first proposal of the new legal framework applicable from 1 June 2022.
The Distribution Law Center (DLC), a new platform for lawyers, practitioners and students looking for essential information on distribution law, is closely monitoring these developments.
From 7 December 2021, the DLC will start releasing countdown newsletters. These countdown letters provide practical and hands-on guidance on the changes that are to be expected and aim to fully prepare businesses for the future.
More information can be found on the DLC website, which can be accessed here.
Contrast selected these topics given their relevance to dental dealers within the EU and hopes that this information will prove useful. Readers should not hesitate to contact Contrast, should they have any questions or require further information.
Sun. 2 October 2022
9:00 pm New York
Wed. 5 October 2022
9:00 am New York
Wed. 5 October 2022
12:00 pm New York
Wed. 5 October 2022
1:00 pm New York