Q&As

What are the rules regarding the advertising of medical devices?

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Produced in partnership with Sarah MacDonald of Wiggin
Published on LexisPSL on 17/10/2017

The following Life Sciences Q&A produced in partnership with Sarah MacDonald of Wiggin provides comprehensive and up to date legal information covering:

  • What are the rules regarding the advertising of medical devices?
  • What constitutes a medical device?
  • What are the restrictions on advertising and marketing medical devices?
  • The ABHI and MedTech Codes
  • The ASA and the CAP and BCAP Codes
  • Substantiating claims
  • Additional restrictions and requirements

What constitutes a medical device?

A 'medical device' is defined in the Medical Devices Regulations 2002 (the Regulations), SI 2002/618, which implement EU Directive 93/42/EEC concerning medical devices (the Medical Device Directive or MDD) in the UK, as:

‘any instrument, apparatus, appliance, software, material or other article […] which—

a) is intended by the manufacturer to be used for human beings for the purpose of:

i diagnosis, prevention, monitoring, treatment or alleviation of disease,

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

iii investigation, replacement or modification of the anatomy or of a physiological process, or

iv control of conception; and

b) does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means […],

and includes devices intended to administer a medicinal product […]’

What are the restrictions on advertising and marketing medical devices?

Unlike EU Directive 2001/83/EC (consolidated version 26.07.2019), the Pharmaceutical Code, neither the MDD nor the Regulations specifically regulate the promotion of medical devices per se. Consequently, the legal landscape for the promotion of medical devices is fragmented and derives from a variety of different sources.

As a general principle, Article 2 of MDD provides that manufacturers of medical devices may only place medical devices on the market that are CE marked in accordance with the provisions of MDD. In this context, a medical device may only be promoted for

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