xmlns:atom="http://www.w3.org/2005/Atom" xmlns:atom="http://www.w3.org/2005/Atom"

SCHEDULES

Regulation 50

SCHEDULE 6U.K.Operational obligations of [F1notified] [F1approved] bodies

1.  [F2An approved] body must carry out conformity assessments in accordance with the relevant conformity assessment procedures.E+W+S

Extent Information

E1This version of this provision extends to England, Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

1.  A notified body must carry out conformity assessments in accordance with the relevant conformity assessment procedures.N.I.

Extent Information

E12This version of this provision extends to Northern Ireland only; a separate version has been created for England, Wales and Scotland only

2.  [F3An approved] body must carry out conformity assessments in a proportionate manner, avoiding unnecessary burdens for economic operators.E+W+S

Extent Information

E2This version of this provision extends to England, Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

2.  A notified body must carry out conformity assessments in a proportionate manner, avoiding unnecessary burdens for economic operators.N.I.

Extent Information

E13This version of this provision extends to Northern Ireland only; a separate version has been created for England, Wales and Scotland only

3.  Conformity assessment bodies must perform their activities taking due account of the size of an undertaking, the sector in which it operates, its structure, the degree of complexity of the apparatus technology in question and the mass or serial nature of the production process.U.K.

4.  Conformity assessment bodies must respect the degree of rigour and level of protection required for the compliance of the apparatus with these Regulations.U.K.

5.  Where [F4an approved] body finds that the essential requirements or the corresponding [F5designated] standards or other technical specifications have not been met by a manufacturer, it must require that manufacturer to take appropriate corrective measures and must not issue a certificate.E+W+S

Extent Information

E3This version of this provision extends to England, Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

5.  Where a notified body finds that the essential requirements or the corresponding harmonised standards or other technical specifications have not been met by a manufacturer, it must require that manufacturer to take appropriate corrective measures and must not issue a certificate.N.I.

Extent Information

E14This version of this provision extends to Northern Ireland only; a separate version has been created for England, Wales and Scotland only

6.  Where, in the course of the monitoring of the conformity of apparatus following the issue of a certificate, [F6an approved] body finds that apparatus is no longer in conformity, it must require the manufacturer to take appropriate corrective measures and must suspend or withdraw the certificate if necessary.E+W+S

Extent Information

E4This version of this provision extends to England, Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

6.  Where, in the course of the monitoring of the conformity of apparatus following the issue of a certificate, a notified body finds that apparatus is no longer in conformity, it must require the manufacturer to take appropriate corrective measures and must suspend or withdraw the certificate if necessary.N.I.

Extent Information

E15This version of this provision extends to Northern Ireland only; a separate version has been created for England, Wales and Scotland only

7.  Where corrective measures are not taken or do not have the required corrective effect, the [F7approved] body must restrict, suspend or withdraw any certificate as appropriate.E+W+S

Extent Information

E5This version of this provision extends to England, Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

7.  Where corrective measures are not taken or do not have the required corrective effect, the notified body must restrict, suspend or withdraw any certificate as appropriate.N.I.

Extent Information

E16This version of this provision extends to Northern Ireland only; a separate version has been created for England, Wales and Scotland only

8.  Paragraph 9 applies where [F8an approved] body is minded to—E+W+S

(a)refuse to issue a certificate; or

(b)restrict, suspend or withdraw a certificate.

Extent Information

E6This version of this provision extends to England, Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

8.  Paragraph 9 applies where a notified body is minded to—N.I.

(a)refuse to issue a certificate; or

(b)restrict, suspend or withdraw a certificate.

Extent Information

E17This version of this provision extends to Northern Ireland only; a separate version has been created for England, Wales and Scotland only

9.  Where this paragraph applies, the [F9approved] body must—E+W+S

(a)give the person applying for the certificate, or the person to whom the certificate was given, a notice in writing giving reasons and specifying the date on which the refusal, restriction, suspension or withdrawal is intended to take effect;

(b)give the person applying for the certificate, or the person to whom the certificate was given, an opportunity to make representations within a reasonable period from the date of the notice; and

(c)take account of any such representations before taking its decision.

Extent Information

E7This version of this provision extends to England, Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

9.  Where this paragraph applies, the notified body must—N.I.

(a)give the person applying for the certificate, or the person to whom the certificate was given, a notice in writing giving reasons and specifying the date on which the refusal, restriction, suspension or withdrawal is intended to take effect;

(b)give the person applying for the certificate, or the person to whom the certificate was given, an opportunity to make representations within a reasonable period from the date of the notice; and

(c)take account of any such representations before taking its decision.

Extent Information

E18This version of this provision extends to Northern Ireland only; a separate version has been created for England, Wales and Scotland only

10.  [F10An approved] body must inform the Secretary of State of—E+W+S

(a)any refusal, restriction, suspension or withdrawal of a certificate;

(b)any circumstances affecting the scope of, or conditions for, notification under regulation 44 (notification);

(c)any request for information which it has received from the market surveillance authority regarding conformity assessment activities; and

(d)on request, conformity assessment activities performed within the scope of its notifications under regulation 44 and any other activity performed, including cross-border activities and subcontracting.

Extent Information

E8This version of this provision extends to England, Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

10.  A notified body must inform the Secretary of State of—N.I.

(a)any refusal, restriction, suspension or withdrawal of a certificate;

(b)any circumstances affecting the scope of, or conditions for, notification under regulation 44 (notification);

(c)any request for information which it has received from the market surveillance authority regarding conformity assessment activities; and

(d)on request, conformity assessment activities performed within the scope of its notifications under regulation 44 and any other activity performed, including cross-border activities and subcontracting.

Extent Information

E19This version of this provision extends to Northern Ireland only; a separate version has been created for England, Wales and Scotland only

11.  [F11An approved] body must make provision in its contracts with its clients enabling such clients to appeal against a decision—E+W+S

(a)to refuse to issue a certificate; or

(b)to restrict, suspend or withdraw a certificate.

Extent Information

E9This version of this provision extends to England, Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

11.  A notified body must make provision in its contracts with its clients enabling such clients to appeal against a decision—N.I.

(a)to refuse to issue a certificate; or

(b)to restrict, suspend or withdraw a certificate.

Extent Information

E20This version of this provision extends to Northern Ireland only; a separate version has been created for England, Wales and Scotland only

12.  [F12An approved] body must provide other bodies [F13approved under these Regulations] carrying out similar conformity assessment activities covering the same type of apparatus with relevant information on issues relating to negative and, on request, positive conformity assessment results.E+W+S

Extent Information

E10This version of this provision extends to England, Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

12.  A notified body must provide other bodies notified under the Directive carrying out similar conformity assessment activities covering the same type of apparatus with relevant information on issues relating to negative and, on request, positive conformity assessment results.N.I.

Extent Information

E21This version of this provision extends to Northern Ireland only; a separate version has been created for England, Wales and Scotland only

13.  [F14An approved] body must participate in the work of [F15any approved] body coordination group established [F16by the Secretary of State], directly or by means of its designated representatives.E+W+S

Extent Information

E11This version of this provision extends to England, Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

13.  A notified body must participate in the work of any notified body coordination group established under the Directive, directly or by means of its designated representatives.N.I.

Extent Information

E22This version of this provision extends to Northern Ireland only; a separate version has been created for England, Wales and Scotland only