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- Original (As made)
This is the original version (as it was originally made).
17.Prohibition on placing apparatus on the market which is not in conformity
18.Requirements that must be satisfied before an importer places apparatus on the market
23.Importer’s duty to take action in respect of apparatus placed on the market which is considered not to be in conformity
24.Retention of technical documentation and EU declaration of conformity
SCHEDULES
Module A: internal production control
1.Internal production control is the conformity assessment procedure whereby the...
3.The electromagnetic compatibility assessment must take into account all normal...
5.The technical documentation must specify the applicable requirements and cover,...
8.The manufacturer must draw up a written EU declaration of...
Applicable conformity assessment procedures
PART 1 Module B: EU-type Examination
1.EU-type examination is the part of a conformity assessment procedure...
2.EU-type examination must be carried out by an assessment of...
3.The manufacturer must lodge an application for EU-type examination with...
4.The technical documentation referred to in paragraph 3(c) of this...
5.The notified body must examine the technical documentation to assess...
6.The notified body must draw up an evaluation report which...
7.Where the type meets the requirements of these Regulations that...
8.The EU-type examination certificate, which may be accompanied by one...
9.The EU-type examination certificate and any annexes to that certificate...
10.Where the type does not satisfy the applicable requirements of...
11.The notified body must keep itself apprised of any changes...
12.The manufacturer must inform the notified body that holds the...
13.Each notified body must inform its notifying authority of any...
14.Each notified body must inform the other notified bodies of...
15.The Commission, the Member States and the other notified bodies...
16.The manufacturer must keep a copy of the EU-type examination...
17.The manufacturer’s authorised representative may lodge the application referred to...
PART 2 Module C: conformity to type based on internal production control
2.Name and address of manufacturer or the manufacturer’s authorised representative:...
3.This declaration of conformity is issued under the sole responsibility...
4.Object of the declaration (identification of apparatus allowing traceability; it...
5.The object of the declaration described above is in conformity...
6.References to the relevant harmonised standards used, including the date...
7.Where applicable, the notified body … (name, number) performed …...
8.Additional information: Signed for and on behalf of: (place and...
Requirements for notified bodies
1.A conformity assessment body must be established in the United...
3.A conformity assessment body, its top level management and the...
4.Nothing in paragraph 3 of this Schedule precludes the use...
5.A conformity assessment body, its top level management and the...
6.A conformity assessment body, its top level management and the...
7.A conformity assessment body must ensure that the activities of...
8.A conformity assessment body and its personnel must carry out...
9.A conformity assessment body must be capable of carrying out...
11.A conformity assessment body must have the means necessary to...
12.The personnel responsible for carrying out the conformity assessment activities...
13.A conformity assessment body must be able to demonstrate the...
14.The remuneration of the top level management and the personnel...
15.A conformity assessment body must have, and must satisfy the...
16.A conformity assessment body must ensure that its personnel observe...
17.Paragraph 16 does not prevent the personnel from providing information...
18.A conformity assessment body must participate in, or ensure that...
Operational obligations of notified bodies
1.A notified body must carry out conformity assessments in accordance...
2.A notified body must carry out conformity assessments in a...
3.Conformity assessment bodies must perform their activities taking due account...
4.Conformity assessment bodies must respect the degree of rigour and...
5.Where a notified body finds that the essential requirements or...
6.Where, in the course of the monitoring of the conformity...
8.Paragraph 9 applies where a notified body is minded to—...
10.A notified body must inform the Secretary of State of—...
11.A notified body must make provision in its contracts with...
12.A notified body must provide other bodies notified under the...
PART 2 COMPLIANCE NOTICES, WITHDRAWAL NOTICES AND RECALL NOTICES
5.A compliance notice must— (a) require the relevant economic operator...
6.A compliance notice may include directions as to the measures...
7.Subject to paragraph 8, an enforcing authority may revoke or...
8.An enforcing authority may not vary a compliance notice so...
10.A withdrawal notice must prohibit the relevant economic operator from...
11.A withdrawal notice may require the relevant economic operator to...
12.A withdrawal notice may require the relevant economic operator to...
13.A consent given by the enforcing authority pursuant to a...
14.Subject to paragraph 15, an enforcing authority may revoke or...
15.An enforcing authority may not vary a withdrawal notice so...
16.A withdrawal notice has effect throughout the United Kingdom.
18.A recall notice must require the relevant economic operator to...
20.In determining what requirements to include in a recall notice,...
22.A relevant economic operator which has received notice from the...
24.Where a relevant economic operator requires the enforcing authority to...
25.In this Schedule, “Institute” means the charitable organisation with registered...
26.A recall notice served by the enforcing authority may require...
27.Subject to paragraph 28, an enforcing authority may revoke or...
28.An enforcing authority may not vary a recall notice so...
29.A recall notice has effect throughout the United Kingdom.
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