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Regulatory ESSENTIAL
United Kingdom - X-RAY Devices

Modular information package with all the essential information for compliant products in your target market.
Conveniently read online at Product-Compliance-Portal ROGER WILLCO.

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Stakeholders:      Manufacturer, Importer, B2C products, B2B products     
Application: x-ray devices, radiation
Countries: Image for GB United Kingdom,  
#ux6c  
Status: Published 2023-03-09 by Inken Green and Torsten Sahm
Last change 2024-07-19 by Anette Dunkel-Reinboth: Regulatory label (mandatory), X-Ray
   
Price 365 day licence for 695.00 € net         Buy this REGULATORY ESSENTIAL >>

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Subject Areas of this Essential:


X-Ray

Scope of this ESSENTIAL
This ESSENTIAL describes the UK regulations on X-Ray devices as Low voltage Devices.

Reg. 3) These Regulations apply to electrical equipment:
(a) placed on the market on or after the commencement date; and
(b) designed for use with a voltage rating of between 50 and 1000V for alternating current and between 75 and 1500V for direct current.'

Hints
here you will get textual information

Specific recommendations, information or most common mistakes

Abbreviations
here you will get a table

Important abbreviations which are special for this legislation or theme.

Analysis of regulatory requirements

Legislation in force for this PCT
here you will get a linked document in ROGER WILLCO
(only reachable with additional ROGER WILLCO licence)

Are legal provisions regulates the product compliance topic? If yes, what is the reference (title, number)?

Legislation in force for this PCT
here you will get a table

Are legal provisions regulates the product compliance topic? If yes, what is the reference (title, number)?

Responsible actors
here you will get textual information

Which actor(s) are responsible for compliance with the legal provisions: e. g. - economic operators (manufacturer, importer, distributor, fulfilment service provider), - user (commercial/industrial/professional), - user (private, consumer)?

Regulatory market access conditions for the actor(s)
here you will get textual information

What are the main regulatory requirements (e. g. conformity assessment fulfilment of essential requirements of Annex I 2006/42/EC) prior placing on the market, importation and putting into service (brief description)

Penalty by this legislation
here you will get textual information

What are the possible penalties (e. g. sales ban, fines) in the case of non-compliance?

Exemption clauses
here you will get textual information

Exempted devices/products or industry sectors.

Sub-federal legislation of states/counties
here you will get related hyperlink(s)

E. g. by 2019 an Inter-Governmental Agreement (IGA) on governance of the Electrical Equipment Safety System (EESS) has been signed by Queensland, Victoria, Western Australia and Tasmania.

FTA/MRA status with EU
here you will get a linked document in ROGER WILLCO
(only reachable with additional ROGER WILLCO licence)

Has the country signed a Free Trade Agreement (FTA) or a Mutual recognition agreement (MRA) with EU?

Authority
here you will get related hyperlink(s)

Name of the authority for approval, registration, market surveillance and/or enforcement

Market surveillance authority
here you will get related hyperlink(s)

Name of the authority for market surveillance and/or enforcement

Link/Reference to other reference document(s)
here you will get a linked document in ROGER WILLCO
(only reachable with additional ROGER WILLCO licence)

Link/Reference to other reference document(s)
here you will get related hyperlink(s)

Comment on the comparability to EU legislation
here you will get textual information

Hints
here you will get textual information

Specific recommendations, information or most common mistakes

Route to compliance

Formal and administrative requirements

Registration at related authority required?
here you will get textual information

Product registration? Manufacturer registration? Importer / Representative registration? if required.

Local representative legally required?
here you will get textual information

[Yes/No]

Equipment authorization (approval process)

Approval process (conformity assessment procedure)
here you will get textual information

Means each legally required approval process prior placing on the market, importation or putting into service

Is the IECEE CB Scheme accepted by the authority/approval body?
here you will get textual information

"[Yes/ No / no information available] [Text] Information (website)"

Conformance document(s) to show compliance to the authority
here you will get textual information

e. g. SDoC, technical documentation (for 10 years), filled-in approval forms (e. g. ACMA in AUT)

Conformance document validity and renewal
here you will get textual information

Validity for Conformance document name mentioned. For mandatory certification validity is important.

Which documents are required by an approval body?
here you will get textual information

e .g. formal application

Is a factory inspection legally required
here you will get textual information

Testing & Standards

Specific requirements for testing
here you will get textual information

e. g. is an accredited test lab. mandatory, limits, test samples, product description

General information to the application of standards
here you will get textual information

e. g. China: GB standards are mandatory, EU: harmonized standards shall be published in the OJEU with respect to "presumption of conformity"

Source for standards for conformity assessment
here you will get related hyperlink(s)

Source for standards for conformity assessment
here you will get textual information

Are national standards based on IEC/ISO standards?
here you will get textual information

Undetailed information

Is in-country testing legally required?
here you will get textual information

Acceptance of foreign test reports
here you will get textual information

Hints
here you will get textual information

Specific recommendations, information or most common mistakes

Regulatory labelling, markings and user information

Regulatory label (mandatory)
here you will get a image or chart

e. g. product label

Regulatory e-labelling allowed?
here you will get related hyperlink(s)

e. g. put the regulatory information and labels in a software menu

Regulatory label (mandatory)
here you will get textual information

e. g. product label

Required information on the product and/or packaging
here you will get textual information

e. g. address of the manufacturer/importer, serial number

User instructions language(s)
here you will get textual information

Regulated by the legal provisions

User instruction requirements and specific compliance notes
here you will get textual information

Form, sentence inside, simple text. E. g. FCC/ISED compliance information, SAR information, battery, environmental information like waste

User instruction requirements and specific compliance notes
here you will get a linked document in ROGER WILLCO
(only reachable with additional ROGER WILLCO licence)

Form, sentence inside, simple text. E. g. FCC/ISED compliance information, SAR information, battery, environmental information like waste

Digital user documentation allowed?
here you will get textual information

User instructions allowed by QR-Code/internet or digital medium or integrated in device with display? Safety instruction allowed by QR-Code or digital medium?

Warnings, symbols
here you will get textual information

e. g. ANSI Z 535.4

General Information:

   United Kingdom

Code, ContinentGBR, Europe
Economic Area
Official LanguageEnglish (plus 6 regional official languages) De facto official language of the United Kingdom is English. Welsh, an official language in Wales, and the only de jure official language in any part of the UK and Scots
Standard InstituteBSI - British Standards Institution | https://www.bsigroup.com/en-US/Standards/
HS CodememberYes, since 1952

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