Public interest, independence and conflicts of interest
Article 6
1. Member States shall confirm that laboratories for which they have submitted an application for designation pursuant to Article 100(1) of Regulation (EU) 2017/746 will perform their tasks as EU reference laboratories in the public interest and in an independent manner within their proposed scopes of designation. That confirmation shall be included in the application. 2. EU reference laboratories shall have a policy to ensure that the members of their staff do not have financial or other interests in the in vitro medical device industry, which could affect their impartiality with regard to the performance of their tasks. The policy referred to in the first subparagraph shall include steps to prevent, identify and resolve conflicts of interest and shall be made available to the Commission upon request. 3. An EU reference laboratory shall not be the designer, manufacturer, supplier, installer, purchaser, owner or maintainer of devices within its scope of designation, nor the authorised representative of any of those parties and shall not be involved in the design, manufacture or construction, marketing, installation, use or maintenance of the devices within its scope of designation. An EU reference laboratory shall not act as a notified body for devices within its scope of designation. Within its scope of designation, an EU reference laboratory shall not perform any tasks related to conformity assessment under Regulation (EU) 2017/746 on request by a notified body, other than the tasks referred to in Article 100(2) of Regulation (EU) 2017/746. 4. An EU reference laboratory shall not enter into collaboration with a device manufacturer or a notified body concerning a joint commercial exploitation if such collaboration falls within its scope of designation.