# The Medical Devices Regulations 2002, Paragraph 7


In Annex 6—
(a) in Section 1, for “authorised representative established within the Community” substitute “UK responsible person”;
(b) in Section 3 for “the competent national authorities” substitute “the Secretary of State”;
(c) in Section 3.1 for “this Directive” substitute “the Regulations”;
(d) in Section 3.2 for the fourth indent substitute—
“–the results of the risk analysis and a list of the designated standards provided for in regulation 3A of the Regulations, applied in full or in part, and a description of the solutions adopted to satisfy the essential requirements where the standards in regulation 3A of the Regulations have not been applied,”;
(e) omit Section 5.

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Source: https://www.legislation.gov.uk/uksi/2002/618/schedule/2A/paragraph/7 (the official version)
Page: https://openlegislation.uk/medical-devices-regulations-2002/schedule-2A/paragraph-7
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.