Introduction to borderline products
Introduction to borderline products

The following Life Sciences guidance note provides comprehensive and up to date legal information covering:

  • Introduction to borderline products
  • What is a borderline product?
  • Medicinal products
  • Medical devices
  • Combination products
  • Cosmetics
  • Food products
  • Biocidal products
  • Advertising of borderline products
  • The role of the MHRA
  • 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 borderline product?

It is often obvious whether a product should be classified as a medicinal product, medical device, cosmetic product, food, or a biocide. On the other hand, the regulatory status of so-called ‘borderline products’ is not immediately clear. The regulatory classification of a product can have important ramifications, for example, on how the product is regulated (and by whom), how long it will take before such product can be commercialised (especially if pre-market approval is required), how the product can be marketed and what advertising claims can be made etc.

This Practice Note provides an introduction to the concept of borderline products, how the regulatory