Article 2 Amendment of article 1 of the principal Order

in paragraph (2), after the definition of “the 1968 Act”, insert the following definition—

• ““device evaluation services” means services consisting of or relating to the evaluation of medical devices or similar devices, or the components of such devices, for the purpose of determining—

  1. (i)

     the performance of those devices or components,

  2. (ii)

     the ease with which they can be used,

  3. (iii)

     whether they are suitable for use in different environments or for different purposes, or,

  4. (iv)

     how the safety and performance of one device or component compares with that of other devices or components intended for use for the same purpose;”;and

in paragraph (3), for “or the Medical Devices Regulations 2002” substitute “the Medical Devices Regulations 2002 or the Blood Safety and Quality Regulations 2005^f1”.