Product safety and single market legislation forms part of the legal code in the UK and EU Member States and failure to comply with it is a criminal offence. Enforcing the legislation is the responsibility of a number of agencies (generally referred to as 'market surveillance authorities'). In the UK, for example, the Health and Safety Executive deal with most machinery safety related actions, the Medicines & Healthcare Regulatory Authority (MHRA) deal with medical devices, and local authority Trading Standards Services (TSS) deal with consumer electrical goods and toy safety.
Enforcement action can come about because a market surveillance authority (MSA) identifies non-compliant product as part of their normal sampling activities, but more often it will be the result of someone identifying an issue with a product, perhaps because of an injury or accident. Priority is usually given to dealing with products which present significant safety risks but enforcement can also come about because product documentation or marking is deficient.
Manufacturers who identify non compliances with their own products are required to inform the relevant MSA and involve them in developing a plan to deal with the non-compliant units.
A risk assessment based approach is used to decide what action is required. Options potentially range between doing nothing to a full product recall with media advertising, and the risk assessment often needs to include consideration of impact on the business and wider society and not just be focused on the obvious risks from the product.
Properly understanding the legal status of non-compliant product can be complex. Frequently, Harmonised European Standards can be used as the basis of a judgement about whether a product is safe or not, but compliance with a standard is rarely of itself a legal requirement.
Sometimes the MSA do not fully understand the structure of legislation or the content of technical standards and their priorities will frequently be different to those of the manufacturer.
Conformance's deep understanding of the legal and technical requirements for product safety can help both manufacturers and MSAs. Our extensive experience of risk assessment includes working in accordance with the European Commission's non-food product recall guidance to determine whether or not a recall is necessary, and if so how best to achieve this.
We are also able to quickly identify the legal requirements for a particular product and help both manufacturers and MSAs to determine whether there are major or minor non-compliances. Work can be completed under legal privilege where required.
Our Recent experience includes:
- Major global supplier of domestic smoke/fire alarms: product recall assessment after a batch of units was manufactured with faulty sensors.
- Internet retailer selling electric scooters: clarify complex legal requirements and advise on product modifications (including packaging and instructions) to make shipment of units already in UK legal for sale;
- Domestic energy metering device supplier: clarify compliance with legislation for repaired units.
- UK Trading Standards Service: screening test of petrol engine powered go-kart to identify clear non compliances to be used as the basis of an action requiring importer to withdraw product from market.
- Major UK importer of automotive accessories: TSS action in respect of non-compliant luggage securing straps.
- UK supplier of large powered doors: advise on response to HSE enforcement action, including clarification of incorrect interpretation of legal requirements by enforcement body.