Medical device manufacturers

We understand that smaller medical device manufacturers need specialist cover at an affordable price. That’s why we adapted our biomedical and life sciences policy to meet the requirements of new start-ups and small organisations working on a modest budget.

Public and products liability is a mandatory cover and can be purchased on a stand-alone basis. Alternatively optional covers can be added to create a package policy.

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Cover can only be purchased via an insurance broker.

Eligible companies must meet specified criteria. Please see below for further details. Our biomedical and life sciences policy may be suitable for those that are unable to comply.

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0345 351 2600

Legal liabilities

  • Public liability / products liability
  • Professional liability
  • Employers’ liability
  • Cyber and data risks

Management risks

  • Directors’ and officers’ liability

Protection of assets

  • Property damage
  • Business interruption
  • Portable equipment
  • Money and personal assault
  • Transit

We can only provide cover under this offering if you are able to comply with the criteria below. If this isn’t possible our biomedical and life sciences product may suit your needs.

Mandatory cover: Public and products liability (standalone and package options)
Cover is available for UK businesses undertaking the manufacture of an approved medical device classified under directive 93/42/EEC or 98/79/EC, or manufacture of laboratory equipment, instruments or apparatus who can confirm the following:

- None of the products are or include:

  • Class 3 medical devices
  • Invasive surgical devices for long term use (30 days or more including concurrent periods)
  • Infusion systems or infusion pumps
  • Specifically designed for pregnant women or minors
  • Impotence products
  • Weight loss products
  • Latex gloves
  • Birth control or fertility products
  • Annex IIb or IIa in vitro diagnostic (IVD) product
  • Specifically designed for Human Immunodeficiency Virus (HIV)
  • Acquired Immunodeficiency Syndrome (AIDS)
  • Transmissible Spongiform Encephalopathies (TSEs) or viral hepatitis
  • Di-(2-ethylhexyl)
  • Phthalate (DEHP) 
  • Mercury

- You comply with the following regulatory and inspection requirements:

  • All products where required by European legislation carry a CE mark
  • All products are manufactured to ISO 13485
  • You have procedures in place to comply with the most recent Medical Device Vigilance System (MEDDEV) guidelines
  • No past or present products have been subject to a Field Safety Corrective Action (FSCA) or been subject to a voluntary or enforced recall due to risk to health
  • You have procedures in place to notify your customers and recall affected products

- You are unaware of any off-label use or misuse of your product

- You have 10 employees or fewer

- Your projected annual income for the forthcoming twelve months does not exceed £500,000 turnover

- Work is neither undertaken at height or with animals

Optional cover: Cyber & data risks (not available in isolation)

Cover is available for UK businesses who undertake the following on ALL computers:

  • Utilise and maintain updated ant-virus, anti-spyware and firewall protections in accordance with the software providers recommendations
  • Undertake a backup of data at least monthly
  • All employees are automatically prompted to change their passwords at least every 90 days
  • Do not operate any websites that process payment online

Optional cover: Directors and officers liability (not available in isolation)

Cover is available for UK businesses who can comply with the following:

  • You have funding in place to continue your business for at least the forthcoming 12 months
  • You are able to pay your debts as they fall due
  • You are a UK registered private limited company with no traded shares

 

Cover is available for UK businesses undertaking the manufacture of an approved medical device classified 
under directive 93/42/EEC or 98/79/EC, or manufacture of laboratory equipment, instruments or apparatus.

Eligible companies must have 10 employees or fewer, with projected annual income for the forthcoming twelve months not exceeding £500,000.

 

Kelly Costello

Development Manager - North

0345 351 2600

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Samantha de Lisle Steele

Development Manager - Central

0345 351 2600

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Mark Lowther

London Manager

0345 351 2600

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