United Kingdom · Question · Written question
HL HL4392
Contact Tracing: Software
Introduced
13 May 2020
Last action
20 May 2020 · Answer
Status
Answered
Sponsors
—
Subjects
Discovery layer
Source updated
20 May 2020
Summary
To ask Her Majesty's Government whether the NHSX COVID-19 contact tracing application is considered to be a Grade 1 medical device in law, and if so, what rules must trials of such a product follow.
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Timeline
13 May 2020
Written question
To ask Her Majesty's Government whether the NHSX COVID-19 contact tracing application is considered to be a Grade 1 medical device in law, and if so, what rules must trials of such a product follow.
Source: Lords
20 May 2020
Answer
The NHSX COVID-19 contract tracing application is considered Class IIa under the Medical Devices Regulations (2002).The legal requirements relating to clinical investigations are set out in the Medical Devices Regulations 2002 (section 16 and section 29) ...
Source: Written answer
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Sponsors
- · Department of Health and Social Care · Answering body
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Sources
PoliticalRepo is an index and interpretation layer, not the authoritative legal source.
- Official source: https://questions-statements.parliament.uk/written-questions/detail/2020-05-13/HL4392
- Open data entity: https://questions-statements-api.parliament.uk/api/writtenquestions/questions/1195816
- uk · wq-1195816 · source updated 20 May 2020