(1) Subject to subarticle (2) of this Article, these Regulations apply to insurance of a class specified in the Annex and to undertakings carrying on such insurance.
(2) These Regulations do not apply to -
(a) the kinds of insurance specified in paragraph 1 of Article 2 of the Directive,
(b) the operations specified in paragraph 2 of Article 2 of the Directive,
(c) mutual associations and other organisations excluded from the application of the Directive by Article 3 thereof,
(d) the Voluntary Health Insurance Board.
(e) the kinds of assistance activity specified in paragraph 3 of Article 2 of the Directive.