Requests from notified bodies regarding tasks referred to in Article 100(2), points (a) and (b), of Regulation (EU) 2017/746
Article 11
1. For each device and each task referred to in Article 100(2), points (a) and (b), of Regulation (EU) 2017/746, a notified body may conclude a contract as referred to in Article 10(1), point (a), of this Regulation with only one EU reference laboratory. 2. The notified body shall provide to the EU reference laboratory all the documentation related to the device and other relevant information in its possession which are necessary to fulfil the task referred to in paragraph 1. That documentation shall be available in any official Union language acceptable to the EU reference laboratory. 3. The EU reference laboratory may request the notified body for clarification of the submitted documentation and information. The EU reference laboratory shall keep a record of such requests. 4. The notified body shall ensure that the manufacturer provides to the EU reference laboratory free of charge any equipment and reference materials developed or prescribed by the manufacturer for a particular device for the purposes of testing that device, provided that the EU reference laboratory does not already possess such equipment. Where the manufacturer permits the use of the device with equipment made available by different manufacturers, the notified body shall ensure that the manufacturer provides the EU reference laboratory with equipment from at least one of these manufacturers and with a justification for the choice made. The manufacturer may also provide any other commercially available equipment or reference materials to the EU reference laboratory free of charge for the purposes of testing the manufacturer’s device. The equipment or reference materials referred to in the first subparagraph shall either be sent to the EU reference laboratory or, in duly justified circumstances, be made available to the EU reference laboratory on the premises of the manufacturer. The notified body shall ensure that the manufacturer provides training to the staff of the EU reference laboratory on the use of the equipment referred to in the first subparagraph, where such training is deemed necessary by the EU reference laboratory in order to operate the equipment. 5. The notified body shall immediately inform the EU reference laboratory of any new information related to the device that has come to its knowledge and that may have an impact on the fulfilment of the task referred to in paragraph 1.