A wide variety of products currently sold in the UK are required to bear a 'CE' marking to show their conformity with various legal requirements.
However, following the end of the Brexit transition period on 31 December 2020, a new UK Conformity Assessed (UKCA) marking is set to be used instead for placing goods on the market in Great Britain.
Businesses in the life sciences and pharmaceuticals sector in particular will need to make sure that they are aware of how this change affects them. For example, not only do the new UKCA marking requirements include medical devices and personal protective equipment, but there are particular qualifications and points to note for these specialist products.
Although there has been some recent uncertainty regarding the rules which will apply to using the UKCA marking, the government has recently clarified matters by issuing guidance on making use of the new mark. Below we've highlighted some key takeaways from the new guidance.
It is worth noting that the government has also issued related guidance on placing manufactured goods on the market in Great Britain from 1 January 2021, along with various other guidance containing specific information for particular product areas (including medical devices).
1. Find Out if Your Products Will Require the UKCA Marking
Most types of goods currently requiring a CE marking to enter the market will need to bear the new UKCA marking, and the new UKCA marking will also apply to aerosol products. A list of 22 product areas to be covered by the new marking is included in the guidance. Pharmaceutical and life sciences businesses should be aware that the product areas covered include medical devices and personal protective equipment.
The guidance explains that the technical requirements for the UKCA marking, along with the applicable conformity assessment processes and standards for demonstrating conformity, will be largely the same as those currently in place. However, this is not always the case and you should review the guidance to identify any changes applying specifically to your products.
Some of the product areas covered by the new UKCA marking will be subject to special rules outside of the 'standard' transition period from CE to UKCA marking. These include medical devices. Affected business may find it helpful to consult the relevant product specific guidance that is currently available on the gov.uk website.
What About Existing Stock?
Existing stock will not need to use the UKCA marking. If, for example, your goods are already on the market in Great Britain prior to 1 January 2021, they will not require the new marking. However, caution is needed here as to when a product is classed as 'on the market' and will not necessarily be covered just because it has been manufactured, even if that product is held in the manufacturing facility as a sold product.
What About Goods to Be Sold in the EU?
Although the UKCA marking will need to be used to sell goods in Great Britain, it will not be recognised on the EU market. Products that require a CE marking at the moment will still need a CE marking for sale in the EU after 31 December 2020.
2. Know When to Use the UKCA Marking
The UKCA marking will be available for use from 1 January 2021. However, in most cases you will still be able to use the CE marking during a year-long transition period ending 1 January 2022. If you're considering taking advantage of this transition period, you should bear in mind that:
- You are encouraged to be ready to use
the UKCA marking as soon as possible before the end of the
transition period even if you are not required to apply the UKCA
marking before that date.
- You can only use CE markings during the
transition period for areas where GB and EU rules remain
identical. If the EU changes its rules and you CE mark your product
under the changed EU rules, you won't be able to sell your
product in Great Britain during the transition period.
- A number of products will need to use
the UKCA marking immediately after 1 January 2021. The guidance
confirms that your products will need the mark from this date if
- are for the market in Great Britain
- are covered by laws requiring UKCA marking
- require mandatory third-party conformity assessment
- have been subject to conformity assessment that was carried out by a UK conformity assessment body and you haven't transferred your conformity assessment files from your UK body to an EU recognised body before 1 January 2021
Although the rules described above will apply in most cases, pharmaceutical and life sciences businesses should be aware that the CE marking will continue to be used and recognised for medical devices until 30 June 2023. From 1 July 2023, medical devices placed on the market in Great Britain will need to conform to the requirements for UKCA product marking. More information about those requirements can be found in the government's guidance on medical devices.
3. Know How to Apply the UKCA Marking
For most products, the UKCA marking should be on the product itself or its packaging. In some cases, it may need to be placed "on the manuals or other supporting literature".
The guidance also lists a number of general rules which apply to placing the UKCA marking. These include making sure that you:
- don't place any marking or sign that may misconstrue the meaning or form of the marking to third parties
- take full responsibility for your product's conformity with the relevant laws when attaching the marking
- don't place the marking unless there is a specific requirement to do so under applicable legislation
In addition, the guidance sets out some rules for using the UKCA image. These include ensuring that:
- the letters forming the marking remain proportional if you reduce or enlarge the size of the marking
- the marking is at least 5mm in height
- and the marking is visible and legible.
4. Be Prepared to Have the Right Technical Documentation in Place
In order to use the UKCA marking, documentation which demonstrates that the product conforms with the regulatory requirements must be kept for up to 10 years after the product is placed on the market. Market surveillance and enforcement authorities will be able to request this information at any time in order to check that the relevant statutory requirements have been fulfilled. The particular legislation that applies to your product will need to be checked for details of the documentation that needs to be kept.
In addition, most products bearing a UKCA marking will require a UK Declaration of Conformity. This document, which will largely comprise the same information as is currently required to be contained in an EU Declaration of Authority, will also need to be available to market surveillance authorities on request.
Making Sure Your Business Is Ready
This new guidance is helpful in clarifying some of the key changes that are taking place and the things that businesses will need to consider in order to make sure that their products are compliant.
However, understanding the precise rules that apply in relation to any particular product is not straightforward, especially if your product falls into one of the special rules categories, for example, medical devices. Businesses in the pharmaceuticals and life sciences sector will therefore need to consider carefully how they are affected, how soon they need to take action and what specialist regulatory advice they may need to obtain.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.