Contents
- 1. The Commission shall take all necessary measures to preven…
- 2. Where an actor or an authorised user suspects a malfunctio…
- 3. Where the Commission identifies a malfunction, it shall ta…
- 4. In addition to the suspension of periods referred to in pa…
- 5. In addition to the suspension of periods referred to in pa…
- 6. When the Commission has established that the malfunction h…
- 7. When the Commission has displayed the notice referred to i…
3.Where the Commission identifies a malfunction, it shall take the following measures:
(a)display, without delay, a notice to that regard (‘malfunction notice’) on the restricted website or the public website, as applicable, unless the nature of the malfunction prevents the Commission from doing so, in which case it shall, to the extent possible, display the notice on the Commission’s dedicated website for medical devices;
(b)suspend the periods for submission of data in Eudamed set out in Regulations (EU) 2017/745 and (EU) No 2017/746, where the malfunction hinders entering of the relevant data.
Where the Commission suspends the periods for submission of data to Eudamed as provided for in the first subparagraph, point (b), the malfunction notice shall specify the time of the display of that notice and the likely duration of the suspension.
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