ANALYSIS

Product Liability Risks for Medical Devices in the UK

In order to fast-track the development, manufacture and supply of key medical equipment and devices vital in the fight against COVID-19, governments, including the U.K. Government, have taken steps to relax some of the usual regulatory requirements applicable to such products.

Changes in the U.K. follow recognition at EU level that the effectiveness of manufacturers launching new products and diversifying their supplier base in order to meet demand would be hampered if there were not changes to existing conformity assessment and market surveillance procedures across the EU (see Recommendation of the European Commission).

The legislative changes made in the U.K. are considered here as well as associated liability issues. The situation is fluid and additional changes may be introduced as the pandemic evolves.

In the U.K., pursuant to existing powers in the Medical Devices Regulations 2002, the MHRA (Medicines and Healthcare products Regulatory Agency) has issued guidance that it may, upon application, authorise the supply of a non-CE marked device in the interests of the protection of health. The CE marking is required for many products as an indicator that the product is in compliance with EU legislation, including as to safety.

In view of the urgent need for ventilators and other breathing aids, the Government issued specifications for the manufacture of this equipment based on the consensus of what is ‘minimally acceptable’ performance in the opinion of anaesthesia and intensive care medicine professionals and medical device regulators. This allowed manufacturers outside the medical device sector such as aeronautical and automotive companies to contribute to the effort to meet the need for ventilators.

Measures to ease regulatory requirements have also been introduced in order to secure the expedited supply of Personal Protective Equipment (PPE) such as surgical visors, gloves and gowns at the EU level and U.K. national level. The degree to which the requirements are eased depends upon whether the PPE is being supplied to the U.K. Government for use by the NHS during the current pandemic or whether it will be placed on the open market. Where supplied only to the Government, it is not necessary, for example, for a conformity assessment to have been commenced, whereas this is a requirement if the PPE in question is to go on the open market (although it need not yet be complete). In any event, the PPE must be manufactured to the standards specified in the guidance, including relevant EU product safety legislation and regulations (which still applies in the Brexit transition period).

As the pandemic has progressed, the focus of the U.K. Government has shifted towards access to COVID-19 testing and testing kits. Manufacturers of testing kits can apply to the MHRA for consideration for product approval, even if specifications are not met. It is also possible to apply for a derogation from CE marking.

As can be seen from the examples above, it is the processes around conformity and compliance that are being eased, not the fundamental standards of safety that manufacturers must comply with. Indeed, the MHRA remains active with its investigative and enforcement activities, including in relation to COVID-19 products.

In terms of injuries caused to individuals by allegedly defective devices or equipment, the laws and rules as to liability have not been changed. The test for defect under the Consumer Protection Act 1987 would still be a "consumer expectation" test, and a claimant would have to show that the defect caused the injury complained of. For tort-based claims, such as in negligence, claimants would have to show that manufacturers breached their duty of care and that the breach caused the injury complained of. While compliance will not absolve manufacturers from liability, being able to show that devices were manufactured to the specification given and in compliance with all applicable regulations will be, as always, a very important part of the defence of any claim. Maintaining proper testing and manufacturing records to demonstrate compliance will also be vital. These matters will also be key to any contractual indemnities offered by the Government in relation to the supply of these items.

Specifically, the U.K. Government has indicated that it will indemnify designers and manufacturers of rapidly manufactured ventilator systems should they be faced with product liability claims. It may be that such indemnification is extended to the designers and manufacturers of other essential medical equipment as the response to the pandemic develops.

The United States has approached these liability issues with an extension to existing legislation that limits the liability of manufacturers relating to specific categories of products. More information on this legislation appears in "New Federal Law Extends Existing Tort Protections for Makers of Certain Products Used to Combat COVID-19."