Part 2AMaking available on the market and putting into service under Regulation (EU) 2017/746

Certificates of free sale under Regulation (EU) 2017/746 – fee10A

A manufacturer or authorised representative who requests a certificate of free sale from the Secretary of State under Article 55 must pay to the Secretary of State a fee of £75.

Retention of documentation relating to conformity assessments10B

1

The liquidator or trustee in bankruptcy of a manufacturer, or of an authorised representative, must—

a

retain for the required period any documentation that consists of, or reasonably could consist of, information to which section 7 of Annex IX applies, and

b

comply with any request made by the Secretary of State during the required period to provide the Secretary of State with the retained documentation.

2

In this regulation, the required period is 10 years after the last device was placed on the market.

UK(NI) indication under Regulation (EU) 2017/74610C

1

This regulation applies if the CE marking is affixed in accordance with Article 18 on the basis of a certificate issued by a notified body established in the United Kingdom.

2

The CE marking must be accompanied by the UK(NI) indication.

3

The UK(NI) indication may be less than 5mm high provided that it is the same height as the CE marking that it accompanies.

4

The manufacturer must affix the UK(NI) indication—

a

visibly, legibly and indelibly, and

b

before placing the device on the market.

5

A person may only make available on the market a device to which this regulation applies if the manufacturer has affixed the UK(NI) indication in accordance with this regulation.