Contents
- 1. For the purposes of the task referred to in Article 100(2)…
- 2. The EU reference laboratories shall decide which laborator…
- 3. EU reference laboratories shall verify the performance of…
- 4. EU reference laboratories shall provide their opinion with…
- 5. The opinion of the EU reference laboratories shall be deta…
5.The opinion of the EU reference laboratories shall be detailed and shall provide reasons for the conclusions and recommendations made.The opinion referred to in the first subparagraph shall provide recommendations for testing referred to in Article 100(2), point (b), of Regulation (EU) 2017/746, including specimens to be tested, the number of samples of the device as well as the frequency for sample or batch testing by an EU reference laboratory, where there are no requirements adopted in accordance with Article 48(13), point (c), of Regulation (EU) 2017/746.
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