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Regulatory ESSENTIAL
United Kingdom - X-RAY Health/Safety

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, Operator     
Application: x-ray, ionizing radiation
Countries: Image for GB United Kingdom,  
#w76s  
Status: Published 2023-03-22 by Inken Green and Torsten Sahm
Last change 2024-03-14 by Torsten Sahm: Link/Reference to other reference document(s), 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

Analysis of regulatory requirements

Hints
here you will get related hyperlink(s)

Specific recommendations, information or most common mistakes

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)?

Scope of legislation
The focus relates to occupational health and safety, which must be ensured by the employer.

see Regulation 3
Subject to the provisions of IRR17 is
- any practice and any work (other than a practice) carried on in an atmosphere containing radon 222 gas at an annual average activity concentration in air exceeding 300 Bq m-3.

BUT the IRR17 also impose some requirements for the manufacturer, supplier and designer of articles for use in work with ionising radiation (see Regulation 32).'

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)

Exemption clauses
here you will get textual information

Exempted devices/products or industry sectors.

Sub-federal legislation of states/counties
here you will get textual information

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

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)

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]

Hints
here you will get textual information

Specific recommendations, information or most common mistakes

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

Hints
here you will get textual information

Specific recommendations, information or most common mistakes

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 textual information

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

Acceptance of foreign test reports
here you will get textual information

Regulatory labelling, markings and user information

Regulatory label (mandatory)
here you will get textual information

e. g. product label

Regulatory e-labelling allowed?
here you will get textual information

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

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

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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