Regulation 5 Interpretation of Part II

“accessory” means an article which, whilst not being a medical device, is intended specifically by its manufacturer to be used together with a medical device to enable it to be used in accordance with the use of the medical device intended by its manufacturer;

“custom-made device” means a relevant device that is—

1. (a)

   manufactured specifically in accordance with a written prescription of a F2registered medical practitioner, or other person authorised to write such a prescription by virtue of his professional qualification, which gives, under his responsibility, specific characteristics as to its design; and

2. (b)

   intended for the sole use of a particular patient,

but does not include a mass-produced product which needs to be adapted to meet the specific requirements of the medical practitioner or professional user;

“relevant device” shall be construed in accordance with regulation 6;

“single-use combination product” means a product which comprises a medical device and medicinal product forming a single integral product which is intended exclusively for use in the given combination and which is not reusable; and

“system or procedure pack” has the same meaning as in article 12 of Directive 93/42.