Paragraph 4

In Article 1 (which relates to the scope of the Regulation), before the first paragraph insert—

“In this Regulation a reference to an Annex to Directive 90/385/EEC or to an Annex to Directive 93/42/EEC is to be construed as a reference to those Annexes as they applied immediately before IP completion day and as modified by Schedule 2A to the Medical Devices Regulations 2002.”.