Could economic operators quickly get clarification on whether a certain article of MDR/IVDR apply

Here some official EU links that give an answer to this question:

1. Introduction
2. European Court of Justice’s ruling in Case C-583/11 (Article 263 TFEU not viable)
3. Advocate General’s opinion in Case C-583/11 (on the same line, but explaining in Paragraphs 120 to 123 how individuals may achieve effective legal protection)

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