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Article: Medical Device Regulations for custom-made devices: answers to ten important questions

1. When was Regulation (EU) 2017/745 originally due to be fully implemented?

A. 26 May 2020

B. 19 May 2018

C. 12 May 1997

D. 24 May 1994

2. Which type of orthodontic retainer can a dental nurse construct, provided they are trained, competent and indemnified?

A. Begg retainer

B. Bonded retainer

C. Hawley retainer

D. Vacuum-formed retainer

3. Under medical device legislation in the European Union and the United Kingdom, which classification rules cover custom-made dental devices?

A. Rule 1 and Rule 4

B. Rule 3 and Rule 6

C. Rule 5 and Rule 8

D. Rule 7 and Rule 10

4. Under Regulation (EU) 2017/745, how long does a copy of the statement that accompanies a custom-made device need to be retained for?

A. at least five years

B. at least ten years

C. at least 15 years

D. at least 20 years

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