The criterion for notification is simply that a consumer product is known to have risks that are incompatible with the general safety requirement - namely, that it is not safe. It is not necessary for there to have been an incident involving personal injury or property damage. ‘Isolated circumstances or products’ do not need to be notified. The new proposed EU Regulation on Consumer Product Safety also makes an exemption from notification ‘if the manufacturers, importers or distributors can demonstrate that the risk can be fully controlled and cannot anymore endanger the health and safety of persons’. It is likely that the UK will have left the EU before this regulation comes into force; however, UK authorities may decide to adopt a similar approach.
In terms of assessing risk to determine whether notification is necessary, PAS 7100 makes reference to the ‘EU RAPEX methodology’, which is now found in Decision 2019/417 (EU) (repealing Decision 2010/15/EU) known as the RAPEX guidelines. The EU risk-assessment methodology looks at the product itself, the product hazard, the abilities and behaviour of the consumer (in particular vulnerable consumers), injury scenarios, the severity and probability of injury and the determination of risk. The number of products supplied or users potentially affected is not a relevant consideration for notification, although it may be taken into account in determining what action to take to address the risk.
Use of the methodology set out in the RAPEX guidelines is recommended in PAS 7100. The nomograph methodology is also recognised, as it can be used to supplement the RAPEX methodology and is applied by some market surveillance authorities. The Reference in PAS 7100 to use of the EU RAPEX methodology is unlikely to change after the UK’s departure from the EU.
The obligation under the GPSR is to notify the authorities ‘forthwith’ (or immediately) upon knowing a product is unsafe. The UK government guidelines advise that in practice this means making a notification as soon as possible, and no later than 10 calendar days of a risk assessment or obtaining other information showing the product is unsafe. Further, where there is a serious risk, the notification should be made no later than three days after the information has been obtained. PAS 7100 confirms that notification should not be delayed because the business is not yet in a position to provide all of the required information. In this case, the additional information should be provided as it becomes available.
Food and drink
Obligations to notify the Food Standards Agency (FSA) and relevant local authority of unsafe food and drink products are governed by Regulation EC/178/2002 on General Food Law (article 19) and the Food Safety and Hygiene Regulations 2013. A food business operator must notify the authorities if it considers or has reason to believe that food it has placed on the market may be injurious to health. (See the FSA’s Guidance Notes for Food Business Operators on Food Safety, Traceability, Product Withdrawal and Recall 2007).
Notification obligations are incorporated into manufacturers and wholesale dealers’ licences and marketing authorisations. The holder of a manufacturer’s licence has a duty to notify the Defective Medicines Report Centre (DMRC) (a unit of the Inspection, Enforcement and Standards Division of the Medicines and Healthcare Products Regulatory Agency (MHRA)) immediately once investigations have identified a defect that could result in recall or other restrictions on supply. Manufacturers who make a notification after a recall has commenced will be in breach of the Human Medicines Regulations 2012 (SI 2012/1916). The DMRC can be contacted for advice prior to a recall being undertaken. For guidance see: A Guide to Defective Medicinal Products (MHRA, 2014). Guidance is also available on the website of the European Medicines Agency, www.emea.europa.eu (to the extent that it remains applicable post-Brexit).
The medical devices directives require vigilance systems that include reporting to the MHRA by the manufacturer or its authorised representative of malfunctions or deteriorations in a device, inadequacies in labelling or instructions for use that might lead or have led to a patient’s or user’s death or serious health effects and any technical or medical reasons for a systematic recall of the devices.
The MHRA’s Directives Bulletin 3 - Guidance on the Operation of the EU Vigilance System in the UK (September 2008) provides interpretation and guidance on notification of different types of incidents. The European Commission also provides up-to-date guidance in document MEDDEV 2.12-1 Rev 8 (2013). In respect of Brexit, in the event of a no-deal scenario, the UK’s participation in the European regulatory network for medical devices would cease and the UK MHRA would take on the responsibility currently undertaken by the EU.
Notification should be immediate upon the defect being known. The guidance contains guidelines on time limits ranging from two days to 30 days depending on the seriousness of the issue.
On 5 April 2017, two new European Regulations on medical devices were adopted and entered into force on 25 May 2017:
- Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No. 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC; and
- Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU.
The new regulations strengthen the regulatory framework relating to medical devices including the pre-market assessment of devices, post market surveillance and the transparency of data. The new rules will only apply after transitional periods of three years after entry into force for the Regulation on medical devices (May 2020) and five years after entry into force for the Regulation on in vitro diagnostic medical devices (May 2022). The Commission has indicated that it will be reviewing its guidance documents over the next few years to take into account the new regulations. Post-Brexit, The Medical Devices (Amendment etc) (EU Exit) Regulations 2019 will transpose all the key elements contained in Regulation EU 2017/745 on medical devices and EU 2017/746 on in vitro diagnostic medical devices, which will be brought into force in line with the transitional timetable being followed by the EU for the full application of the two regulations.
Supplemental to the general consumer product laws above, the DVSA’s Vehicle Safety Defects and Recalls: Code of Practice (2014) applies to all vehicles (private and commercial). It requires notification to the DVSA by manufacturers of vehicle or component parts, importers, distributors or concessionaires of ‘safety defects’ (defined as a failure because of design or construction that is likely to affect the safe operation of the product without prior warning to the user and may pose a significant risk to the driver, occupants and others). The DVSA’s Code of Practice and Manufacturers’ Guide to Recalls in the UK Automotive Sector (April 2014) advocates early notification of alleged safety defects, even when all the information usually supplied on the official notification form is not available.
Back to top