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Regulation 5(1), (2) and (3) [F1and regulation 12(1)]

SCHEDULE 1U.K.

Textual Amendments

PART 1U.K.Categories of EEE to which these Regulations apply

1.  Large household appliances.U.K.

2.  Small household appliances.U.K.

3.  IT and telecommunications equipment.U.K.

4.  Consumer equipment.U.K.

5.  Lighting equipment.U.K.

6.  Electrical and electronic tools.U.K.

7.  Toys, leisure and sports equipment.U.K.

8.  Medical devices.U.K.

9.  Monitoring and control instruments including industrial monitoring and control instruments.U.K.

10.  Automatic dispensers.U.K.

11.  Other EEE not covered by any of the categories above.U.K.

PART 2U.K.EEE to which these Regulations do not apply

12.  Equipment which is necessary for the protection of the essential interests of the security of [F2the United Kingdom], including arms, munitions and war material intended for specifically military purposes.E+W+S

Extent Information

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

Textual Amendments

12.  Equipment which is necessary for the protection of the essential interests of the security of [F12the United Kingdom or] member States, including arms, munitions and war material intended for specifically military purposes.N.I.

Extent Information

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

Textual Amendments

13.  Equipment designed to be sent into space.U.K.

14.  Equipment which is specifically designed, and is to be installed, as part of another type of equipment to which these Regulations do not apply, which can fulfil its function only if it is part of that equipment, and which can be replaced only by the same specifically designed equipment.U.K.

15.  Large-scale stationary industrial tools being a large-scale assembly of machines, equipment, and/or components—U.K.

(a)functioning together for a specific application;

(b)permanently installed and de-installed by professionals at a given place; and

(c)used and maintained by professionals in an industrial manufacturing facility or research and development facility.

16.  Large-scale fixed installations being a large-scale combination of several types of apparatus and, where applicable, other devices, which are—U.K.

(a)assembled and installed by professionals;

(b)intended to be used permanently in a pre-defined and dedicated location; and

(c)de-installed by professionals.

17.  Means of transport for persons or goods, excluding electric two-wheel vehicles which are not type-approved.U.K.

18.  Non-road mobile machinery made available exclusively for professional use, being machinery, with an on-board power source [F3or with a traction drive powered by an external power source], the operation of which requires either mobility or continuous or semi-continuous movement between a succession of fixed working locations while working, and which is made available exclusively for professional use.U.K.

Textual Amendments

19.  Active implantable medical devices.U.K.

20.  Photovoltaic panels intended to be used in a system that is designed, assembled and installed by professionals for permanent use at a defined location to produce energy from solar light for public, commercial, industrial and residential applications.U.K.

21.  Equipment specifically designed solely for the purposes of research and development only made available on a business-to-business basis.U.K.

[F421A.  Pipe organs.]U.K.

Textual Amendments

PART 3U.K.Categories of EEE with special rules of application

22.  Regulations 3(1), 10, 15, 19, 20, 21, 22, 23, 25, 26, 27 and 28 do not apply—U.K.

(a)to medical devices and monitoring and control instruments placed on the market before 22nd July 2014;

(b)to in vitro diagnostic medical devices placed on the market before 22nd July 2016; F5...

(c)to industrial monitoring and control instruments placed on the market before 22nd July 2017; [F6and

(d)to all other EEE that was outside the scope of the 2002 Directive and which is placed on the market before 22nd July 2019.]

Textual Amendments

23.—(1) Regulations 3(1), 10, 15, 19, 20, 21, 22, 23, 25, 26, 27 and 28 do not apply to cables or spare parts for the repair, the reuse, the updating of functionalities or upgrading of capacity of the following—U.K.

(a)EEE placed on the market before 1st July 2006;

(b)medical devices placed on the market before 22nd July 2014;

(c)in vitro diagnostic medical devices placed on the market before 22nd July 2016;

(d)monitoring and control instruments placed on the market before 22nd July 2014;

(e)industrial monitoring and control instruments placed on the market before 22nd July 2017;

[F7(ea)all other EEE that was outside the scope of the 2002 Directive and which is placed on the market before 22nd July 2019;]

(f)EEE which benefited from an exemption listed in the Directive or the [F82002 Directive] and which was placed on the market before that exemption expired, provided that the specific exemption concerned those cables or spare parts.

F9(2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

[F1024.  Provided that reuse takes place in auditable closed-loop business-to-business return systems, and that the reuse of spare parts is notified to the consumer, regulations 3(1), 10, 15, 19, 20, 21, 22, 23, 25, 26, 27 and 28 do not apply to reused spare parts—U.K.

(a)recovered from EEE placed on the market before 1st July 2006 and used in EEE placed on the market before 1st July 2016;

(b)recovered from medical devices or monitoring and control instruments placed on the market before 22nd July 2014 and used in EEE placed on the market before 22nd July 2024;

(c)recovered from in vitro diagnostic medical devices placed on the market before 22nd July 2016 and used in EEE placed on the market before 22nd July 2026;

(d)recovered from industrial monitoring and control instruments placed on the market before 22nd July 2017 and used in EEE placed on the market before 22nd July 2027;

(e)recovered from all other EEE that was outside the scope of the 2002 Directive and which is placed on the market before 22nd July 2019, and used in EEE placed on the market before 22nd July 2029.]

Textual Amendments

[F11PART 4E+W+SInternal Production Control Procedure

Textual Amendments

25.  The internal production control procedure is a conformity assessment procedure whereby a manufacturer must ensure EEE is manufactured in compliance with the technical documentation and with the applicable requirements of these Regulations.

26.  The technical documentation must—

(a)make it possible to assess the EEE's conformity with the applicable requirements of these Regulations, and must include an adequate analysis and assessment of the risks;

(b)specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and operation of the EEE;

(c)contain, where applicable, at least the following elements—

(i)a general description of the EEE;

(ii)conceptual design and manufacturing drawings and schemes of components, sub-assemblies;

(iii)descriptions and explanations necessary for the understanding of those drawings and schemes, and the operation of the EEE;

(iv)a list of the designated standards applied in full or in part (where applicable specifying the parts which have been applied);

(v)where designated standards have not been applied, descriptions of the solutions adopted to meet the essential requirements, including a list of other relevant technical specifications applied;

(vii)results of design calculations made, examinations carried out and

(viii)test reports.]