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Parliamentary questions
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13 February 2020
Question for written answer E-000887/2020
to the Commission
Rule 138
Esther de Lange (PPE)
 Answer in writing 
 Subject: Notification requirement for shortages of medical devices

On Monday, 10 February, hospitals in the Netherlands called (1) for the introduction of a requirement for factories to notify the authorities of any impending shortages of medical devices. They fear that care may be acutely endangered due to the requirement for medical devices to comply with more stringent European rules from 26 May onwards. The European Medical Devices Regulation makes it compulsory to demonstrate by means of various tests that a product is safe and effective.

1. What is the Commission’s assessment of the above-mentioned news, and is it aware of any impending shortages in other Member States because manufacturers may not have medical devices approved (or reapproved) in time?

2. What impact does the Commission expect that Brexit will have on the number of approved EU inspection bodies that assess the safety of medical devices, as it has already fallen from 55 to 9 in recent years? And if the current number of approved inspection bodies is too small: how does the Commission intend to ensure that medical devices are certified in good time?

3. In what concrete ways does the Commission intend to avert impending shortages of medical devices, and does it agree that a European requirement for manufacturers to notify impending shortages is one of the options?

Original language of question: NL
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