The UK Government have introduced new UKCA conformity marking to replace CE Marking, and this will effective on 1st Jan 2021. The new UKCA Marking requirement will be used for products being placed on the market in Great Britain (England, Wales and Scotland), replacing the EU requirements for CE Marking. It covers most products that previously required the CE mark.
There are 3 major issue about UKCA marking and CE Marking in coming two years.
- Mandatory for NEW applicable products placed on the UK market from 1st Jan 2021.
- Mandatory for ALL applicable products placed on the UK market from 1st Jan 2022.
- The recognition of existing CE marking will be valid in the UK until 1st Jan 2022.
Note: Conformity Assessment tasks must be carried out by a UK Approved Body.
Northern Ireland will conform to the same requirements but under a UKNI marking.
Manufacturer, authorised representative (where allowed for in the relevant legislation), must keep documentation to demonstrate that product conforms with the statutory requirements. This information can be requested at any time by market surveillance or enforcement authorities to check that product conforms with the statutory requirements. This can be up to a maximum of 10 years after the product is placed on the market.
Rules for using the UKCA Logo
The user must make sure that:
- if he reduce or enlarge the size of your marking, the letters forming the UKCA marking must be in proportion to the version set out below
- the UKCA marking is at least 5mm in height – unless a different minimum dimension is specified in the relevant legislation
- the UKCA marking is easily visible, legible (from 1 January 2023 it must be permanently attached)
UK Declaration of Conformity
The UK Declaration of Conformity is a document which must be drawn up for most products lawfully bearing a UKCA marking.
In the document the manufacturer, or authorised representative (where allowed for in the relevant legislation), should:
- declare that the product is in conformity with the relevant statutory requirements applicable to the specific product
- make sure the document has the name and address of the manufacturer (or your authorised representative) together with information about the product and the conformity assessment body (where relevant)
The UK Declaration of Conformity should be available to market surveillance authorities on request. The information required on the Declaration of Conformity will be largely the same as what is currently required on an EU Declaration of Conformity.
Manufacturer / authorised representative will need to list:
- relevant UK rather than EU legislation
- UK designated standards rather than standards cited in the Official Journal of the European Union
On 1 January 2021 the UK standards will be the same in substance and with the same reference as the standards used in the EU. However, they will use the prefix ‘BS’ to indicate that they are standards adopted by the British Standards Institution as the UK’s national standards body.
UK Responsible Person for medical device
The UK Responsible Person will act on behalf of the outside-UK manufacturer to carry out specified tasks in relation to the manufacturer’s obligations. This includes registering the manufacturer’s devices with the MHRA before the devices can be placed on the Great Britain market.
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