Paragraph 16 Power to decommission or switch off any medical device

(1)

The power in sub-paragraph (2) is available to an officer of an enforcer acting pursuant to the duty in regulation 61(1A) or (1B) of the Medical Devices Regulations 2002 or to a duty in regulations made under section 15(1) of the Medicines and Medical Devices Act 2021.

(2)

The officer may decommission or switch off any medical device to which the Medical Devices Regulations 2002 apply which is installed at a given location.

(3)

An enforcer may exercise the power in this paragraph—

(a)

if an officer of the enforcer reasonably suspects a contravention of an obligation on an economic operator under any of—

(i)

the Medical Devices Regulations 2002;

(ii)

regulations made under section 15(1) of the Medicines and Medical Devices Act 2021; and

(b)

for the purpose of ascertaining (by means of testing or otherwise) whether there has been such non-compliance.