Product, Safety, Liability and Recall
3D printing of medical devices will transform healthcare but give insurers a headache
3D printing, or additive manufacturing, can already produce custom-made implants and prosthetics, as well as detailed anatomical models to help clinicians prepare for the most complex of surgical procedures. Now, the technology could create tissue and organs as it takes personalised medicine to a new level.
But the legal issues are untested. What is the product and who is the manufacturer where a design, computer program, raw materials and printer may all have been supplied by different parties? If someone is injured, can the defect that caused the damage be identified and will the existing tort law framework be able to respond? The many risks posed by the technology will need insuring and understanding the issues is the first step to minimising liability.
New product safety code will ensure greater consistency and traceability
The new Office for Product Safety and Standards (OPSS) should provide a focal point for product safety in the UK. It is not a replacement for the current locally based regulators within Local Authority Trading Standards departments. With the OPSS’ new Code of Practice for product safety recalls, expect greater consistency. Although not legally binding, following the Code offers businesses a clear and tangible way of demonstrating compliance with product safety legislation. Expect also more formal traceability and tracking near misses and field quality complaints, often the first seeds of the need to consider a product recall. The Code should also see greater predictability about how regulators will react and encouragement for Primary Authority relationships.
The Internet of Things should be secure by design
Cybersecurity should be provided by design and not be left to consumers to address. This was a key theme of the March 2018 report, Secure by Design, from the Department for Culture, Media and Sport. The report also issued a challenge to the market to solve the risks posed by the Internet of Things. The Government will be reviewing progress through 2018 and we can expect regulation if progress is not made. The Government proposes to create incentives for the industry to improve behaviour along the supply chain. Summer 2018 will see publication of a Code of Practice to include a compliance framework with practical measures to improve cybersecurity through the product life cycle.