UKCA: the new marking within the UK market

Must comply with the UK legislation instead of the EU legislation.

Placing your product on the UK market means that you need to comply with the UK Regulations. Both the applicable EU legal framework for certain products as well as the equivalent UK legal framework which has entered into force as of 1 January 2021, are familiar.

Note: in case you are seeking an UKCA certification during the transition period, you need to consider the UK Regulations currently in force, and therefore, your product needs to comply with the essential health and safety requirements as set out in the applicable regulations.

Must have UKCA Manufacturer’s Declaration of Conformityinstead of the CE Manufacturer’s Declaration of Conformity

This is the document that must be drawn up for most products legally bearing a UKCA marking

Largely similar to the EU Declaration of Conformity, the UKCA Declaration of Conformity, requires specific information:

• your name and full business address or that of your authorised representative ;
• the product’s serial number, model or type identification ;
• a statement, stating you take full responsibility for the product’s compliance;
• the details of the approved body which carried out the conformity assessment procedure (if applicable);
• the relevant legislation with which the product complies;
• your name and signature;
• the date the declaration was issued;
• supplementary information (if applicable).

Please, remember: the UKCA Manufacturer’s Declaration of Conformity must be available to market surveillance authorities upon request.

Becomes UK Approved Body for the GB market

In case a Third-Party Conformity Assessment is mandatory for specific products intended for the GB market, this requirement will also remain applicable in the UK. A UK Market Recognized Conformity Assessment Body (UKMCAB) must conduct the mandatory third-party conformity assessment in order for a manufacturer to obtain the UKCA Marking. It is important to underline that EU Notified Bodies are not qualified to conduct the conformity assessment according to UKCA legislation. Therefore, the Notified Bodies that are located in Great Britain will be registered as UK approved bodies – referring to the approved UK-based bodies for the GB market.
However, as of 1 January 2021, the UK approved bodies will still continue to act as Notified Bodies for the Northern Ireland market.

In case you wish to place your product on the market within the European Union and you are based in the UK, you must appoint a European Authorized Representative. As of 16 July 2021 an amended Regulation (EU) 2019/1020 will come into force regarding the assignment of Authorized Representatives. An EU Authorized Representative is a natural person or a legal entity that acts on behalf of the manufacturer within the CE legislation.

In case you, as an EU manufacturer, wish to place your product on the UK market and you are based within the EU (or EEA), you may choose (or, if necessary, need) to appoint a UK Authorized Representative to act on your behalf. You can delegate some of the tasks you are responsible for to your UK AR, such as:

• Determining compliance with the GB regulations, and
• Drawing up documentation, such as the Declaration of Conformity.

Whether it is possible to appoint a UK AR and which tasks can be delegated, depends on the regulations applicable to your product.

Please keep in mind that EU manufacturers based outside the UK who are planning to place medical devices on the GB market, need to appoint a UK Responsible Person to act on their behalf.