作者

Katie Chandler

合伙人

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Edward Spencer

高级法律顾问

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Max Kempe

律师

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Matthew Caskie

律师

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作者

Katie Chandler

合伙人

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Edward Spencer

高级法律顾问

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Max Kempe

律师

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Matthew Caskie

律师

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2021年8月31日

Product Protection – 1 / 20 观点

Launching a product on the GB market – Q&A guide

  • Briefing

A practical guide covering all the pre-launch and post-launch issues product manufacturers need to consider.

Pre-launch considerations

Are there special categories of products with their own set of rules?

Yes, these are:

  • food/drink 
  • toys
  • pharmaceuticals
  • medical devices
  • chemicals
  • vehicles 
  • aerospace 
  • cosmetics 
  • tobacco products 
  • fertilisers 
  • products that require eco design/eco labelling 
  • construction products
  • civil explosives, and
  • rail interoperability constituents.
What are my general product safety obligations? 

You are obligated to:

  • only provide safe products to consumers
  • provide consumers with all relevant information to use the product safely, and
  • take necessary precautions to avoid product safety incidents and respond appropriately if they do happen. 
What can I do to try to achieve this? 

Examples of the actions you can undertake include to:

  • provide clear and thorough instructions with your product in local language of the market
  • carry out sample testing where appropriate
  • conduct product safety investigations
  • keep a register of product safety complaints, and
  • keep full tracing record of products.
What records should I be keeping? 

You should maintain:

  • good records of your product's technical documentation
  • details of the suppliers you sell to so they can be traced if a product recall/withdrawal is necessary, and
  • records of complaints and any reported safety issues.
Are warning signs enough? 
  • Warning signs can help to show you are providing consumers with the relevant information and taking precautions but are unlikely to be enough on their own.
  • You still need to make sure your product is safe and provide full instructions which address any known risks or safety warnings.
What about my label? What do I need to include on that? 

Your label needs to include:

  • the name and address of the manufacturer, or the manufacturer's representative (see below). 
  • the product reference or (where applicable) product batch. 
Do I need insurance? 
  • Product liability insurance mitigates the risk of consumers suing your company for compensation based on harm they allege to have suffered because of your product. 
  • If your product is unsafe and causes personal injury or death the compensation involved will be substantial. 
  • The UK also has a strict liability regime for defective products, which means that if a product is found to be defective and causes damage, your company can be held liable in a court case even if you, as the manufacturer, have not been negligent. 
  • Product liability insurance does not always cover recall costs. Check your policy wording.
I've heard about authorised representatives. Do I need one? 
  • US companies can appoint a manufacturer's representative in the UK for entering the GB market. The advantage of this is that the manufacturer's representative can take on some of the duties of the manufacturer. This can include dealing with conformity assessments and responding to enquiries by the UK regulators.
  • The address of the manufacturer's representative will need to appear on the product label. 
  • Following Brexit, EU-based authorised representatives/responsible persons will not be recognised under GB rules. If you are entering the UK market, your authorised representative must be based in the UK.
Do I need a CE mark? 
In GB, a new UKCA has replaced the European Union's CE marking. It will apply to most goods that previously had to display the CE mark but will also include products like aerosols.
How do I obtain my UKCA mark?
Your product must meet the necessary technical requirements, and in many cases, you will need to undertake a conformity assessment carried out by you or a third party. This third party must be a UK conformity assessment body based in the UK, which must be accredited by the UK government. There is a set list – the UK Market Conformity Assessment Bodies database – on the UK government website.
What are designated standards? 
These are standards that are recognised by the UK government and are published on the UK government website. Designated standards are set by a list of recognised standardisation bodies including the BSI Standards Association and the International Organisation for Standardisation (for example, you may have seen the prefixes BS or EN ISO and the standard number attached to products).
What is the presumption of conformity? 
Meeting designated standards will, in many cases, allow for the presumption of conformity to be satisfied. This means that a product that meets the relevant designated standards will be considered compliant with the product safety legislation it falls under.
Do I need to do a conformity assessment? 
This is needed for some classes of products. In some cases, it can be done by the manufacturer, in others it will need to be done by a recognised organisation known in the UK as a Conformity Assessment Body (you may see the term Approved/Notified Body).
What does a conformity assessment involve? 
Specific requirements will differ for different product types, but it will often cover aspects of the product's development including design, technical documentation and testing. The assessment will determine whether the product complies with all the relevant legislation and can be considered safe to enter the market.

Post-launch considerations

What are my product safety obligations once my product has launched? 
You need to adopt measures to ensure that you are kept informed of any risks posed by your product and take action if any risks present themselves.
What do I do if I become aware of a product safety risk? 

You need to take appropriate action, including: 

  • notifying the relevant authorities
  • considering whether you need to withdraw the product from the market, and 
  • considering a product recall (recalling the product from customers who have already purchased it).
What other action might I have to take?

You may have to:

  • issue new instructions for use or labels, and/or
  • modify the product. 
Who are the relevant authorities? 
  • Trading Standards for consumer products (in England) managed by the Office of Product Safety Standards (OPSS). 
  • The Health and Safety Executive (HSE) for non-consumer products (like equipment used at work) (in England).
What powers do they have? 
  • Trading Standards and the HSE have the authority to launch their own investigations into a product safety concern. 
  • They have the power to withdraw your product from the market or recall it. 
  • They can prosecute you and have the power to issue unlimited fines for some offences. 
Can members of the public or my competitors report me to the authorities? 
Yes, anyone can make a complaint to the authorities which could result in an investigation. 
When do I need to warn the authorities? 
  • You need to warn the authorities if you become aware that your product may be unsafe. Notifications to the authorities are often made following product safety incidents. 
  • Manufacturers are required to act quickly and notify as soon as possible.
How do I do this? 
Trading Standards and the HSE can be contacted by phone and email. Voluntary notifications of a potential product safety issue can be made to these bodies.
Can Taylor Wessing help with this? 
Yes – at Taylor Wessing, we have the expertise to manage this process and can prepare product safety notifications and manage dealings with the relevant authorities. We can also advise you on any regulatory investigation, product recall, brand management issues and any follow on product liability litigation.

本系列内容

产品责任与产品安全

Launching a product on the GB market – Q&A guide

Briefing

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产品责任与产品安全

Big changes coming to the EU's product safety regime

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纠纷和调查

High Court rules consumers cannot circumvent 10 year longstop for claims

Wilson v Beko [2019] EWHC 3362 (QB)

作者 Katie Chandler, Max Kempe

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