The medical device industry in the UK is heavily regulated. Legislation in the UK implements all of the EU directives regulating medical devices.
These directives are designed to benefit patients and users by setting out essential requirements that medical devices must meet. Medical devices must not compromise the health or safety of the patient, user or any other person. Any risks associated with the device are compatible with patient health and protection.
This means that any deviation from compliance and safety procedures could expose a business to unsustainable levels of risk. Therefore insurance is vital to offer protection to medical device companies against perils that may ultimately impact patient health and safety.
Insurance, however, can be difficult to find and when you find it, it can be very expensive. It is vital therefore to find an insurance broker that understands the market place. Also, more importantly, a broker with access to all of the insurers that are interested in providing the insurance that is required. This is essential especially for micro and/or start-up medical device companies as the cost of insurance can be a very significant hurdle.
Recent developments in the medical device industry led to a review of the company exposure to risk. Working with our insurance broker a thorough audit of the current insurance contract was undertaken to ensure that there were no gaps in cover. This was followed by an assessment of the existing coverage and risk management techniques to ensure that they adequately met the company needs. Special attention was devoted to identifying any gaps in coverage that put the company at increased risk, such as Asset Protection, Insurance for Clinical Trials, Product Withdrawal Expenses, Loss of Research and Development Funding, and Product Liability for Medical Devices.
The insurance broker review enabled the company to identify the key areas of the medical device industry such as research and development, medical device distribution and medical device manufacture, and ensure that the company had in a place a policy that meets the requirements of the company and those of the current medical device industry legislation.
