Regulation 50
1. A notified body must carry out conformity assessments in accordance with the relevant conformity assessment procedures.
2. A notified body must carry out conformity assessments in a proportionate manner, avoiding unnecessary burdens for economic operators.
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.
4. Conformity assessment bodies must respect the degree of rigour and level of protection required for the compliance of the apparatus with these Regulations.
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.
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.
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.
8. Paragraph 9 applies where a notified body is minded to—
(a)refuse to issue a certificate; or
(b)restrict, suspend or withdraw a certificate.
9. Where this paragraph applies, the notified body must—
(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.
10. A notified body must inform the Secretary of State of—
(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.
11. A notified body must make provision in its contracts with its clients enabling such clients to appeal against a decision—
(a)to refuse to issue a certificate; or
(b)to restrict, suspend or withdraw a certificate.
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.
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.