Intellectual property protection for medical devices
Produced in partnership with Reuben E Jacob and Dr Edward Rainsford
Intellectual property protection for medical devices

The following Life Sciences practice note Produced in partnership with Reuben E Jacob and Dr Edward Rainsford provides comprehensive and up to date legal information covering:

  • Intellectual property protection for medical devices
  • What is a medical device?
  • Medical device life cycle
  • Conception and initial research
  • Confidentiality and non-disclosure agreements
  • Trade secrets
  • IP ownership
  • Freedom to operate
  • Patents
  • Copyright and designs
  • More...

On 31 January 2020, the UK ceased to be an EU Member State and entered an implementation period during which it continues to be treated by the EU as a Member State for many purposes. As a third country, the UK can no longer participate in the EU’s political institutions, agencies, offices, bodies (except to the limited extent agreed), but it continues to be subject to EU law and must submit to the continuing jurisdiction of the Court of Justice of the EU in accordance with the transitional arrangements in Part 4 of the Withdrawal Agreement. For further reading, see: Brexit—Life Sciences and News Analysis: Brexit Bulletin—key updates, research tips and resources.

What is a medical device?

‘Medical device’ is a broad term that covers a wide range of products involved in human or animal health and encompasses very simple devices, such as tongue depressors, to complex products, such as pacemakers.

The Medical Devices Regulations 2002, SI 2002/618 (as amended) define a medical device as:

‘an instrument, apparatus, appliance, material or other article, whether used alone or in combination, together with any software necessary for its proper application, which is intended by the manufacturer to be used for human beings for the purpose of:

  1. diagnosis, prevention, monitoring, treatment or alleviation of disease,

  2. diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,

  3. investigation, replacement or modification

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