Medical devices

Biomedical and life sciences insurance

Manufacturing or distributing medical devices comes with huge responsibility – organisations face a complex set of risks including device failure, injury or product recalls. There is also the added pressure of legislative requirements, as the medical device industry is highly regulated.

Many of the risks may not be covered under a general liability insurance, but would be covered under the specialist policy we offer.

Our coverage is tailored for UK based SMEs in the following fields:

  • Research and development
  • Manufacturers
  • Importers
  • Wholesalers
  • Distributors

Legal liabilities

    • Liability - injury and property damage
    • Liability - financial loss
    • Clinical trials
    • Employers’ liability

Management risks

    • Entity defence
    • Directors’ and officers’ liability

Protection of assets

    • Property damage
    • Business interruption
    • Specified all risks
    • Money and personal assault
    • Transit

Extensions available

    • Public utilities
    • Denial of access
    • Restrictions to premises
    • Customers extension
    • Suppliers extension
    • Product withdrawal expense

Medical Device Manufacturer - Risk example

The policyholder is a large medical device manufacturer, established in 2006, producing a variety of single use instruments for use in general surgery. Based in the United Kingdom the company has built up a strong client base including the NHS and a number of overseas contracts.

The issues

Whilst the organisation is experienced and well-managed there was one issue that required further investigation before we could agree terms. In its early days the company had been involved in the development and sales of an orthopaedic implant.

As such the company needed retroactive cover for these products. There had been no safety issues, but the company found it difficult to find an insurance carrier that would agree to cover the more onerous implant exposure together with the relatively straight forward instrument product they were now involved with.

The solution

In this sector we are used to seeing new and challenging technologies so we find comfort in understanding how our potential clients manage the associated risks.

  • We undertook research into the safety profile of the orthopaedic product and similar products to determine if there was any current or potential litigation being talked about.
  • We met with the client to understand their business and discuss their demands and needs going forward.
  • The client demonstrated to us a high level of competence in their field and we demonstrated to them our commitment and expertise to providing insurance in this sector.
  • We provided cover on a worldwide basis including retroactive cover for the orthopaedic products.

Alongside insurance solutions, we can also assist your clients with tax and funding services such as R&D tax relief, tax funding and patent box through our partner Abbey Tax. 

Download the service brochures below: 

For more information about any of these specialist tax and funding services, please contact your local Markel underwriter.