Sample or batch testing
Article 13
1. For the purposes of the task referred to in Article 100(2), point (b), of Regulation (EU) 2017/746, the notified body shall propose a sample or batch test plan for the device to the EU reference laboratory, taking into account, if applicable, the recommendations of the EU reference laboratory referred to in Article 12(5), second subparagraph, of this Regulation. The EU reference laboratory may propose amendments to the test plan referred to in the first subparagraph. The EU reference laboratory shall provide reasons for such proposals. The notified body and the EU reference laboratory shall agree on the final version of the test plan referred to in the first subparagraph. That plan shall comply with the applicable common specifications and any requirements adopted in accordance with Article 48(13), point (c), of Regulation (EU) 2017/746. 2. The notified body shall make available to the EU reference laboratory performing the sample or batch testing the following documentation: (a) if applicable, the EU reference laboratory opinion issued after performing the task referred to in Article 100(2), point (a), of Regulation (EU) 2017/746, if that task was performed by a different EU reference laboratory; (b) the findings of any previous sample or batch tests performed on the device by other EU reference laboratories in accordance with Article 100(2), point (b), of Regulation (EU) 2017/746. The EU reference laboratory shall take account of the opinion and the findings referred to in the first subparagraph when proposing amendments to or agreeing on the final version of the plan referred to in paragraph 1. 3. The notified body shall, in agreement with the manufacturer, put in place logistic arrangements with the EU reference laboratory to ensure that the EU reference laboratory has sufficient time after the reception of the samples to perform the testing and provide its findings to the notified body. These arrangements shall take into account the time needed for the notified body to communicate a possible decision to the manufacturer within the agreed timeframe, but not later than 30 days after reception of the samples. 4. The findings of the EU reference laboratory on the results of the sample or batch testing shall be detailed and include reasons for the conclusions made.