FAQs
Frequently Asked Questions
CE Marking and other forms of regulatory compliance can be confusing, here are a few of the most common questions we are asked by our customers.
What is CE Marking?
CE Marking is a certification mark that shows compliance with the relevant health, safety and environmental regulations for products sold or used in the European Union.
Do I need CE Marking?
CE Marking is a certification mark that shows compliance with the relevant health, safety and environmental regulations for products sold or used in the European Union.
How do I get my product CE marked?
Except for a few high-risk industries, most products can be CE marked by the manufacturer. Although you may be able to legally ‘self-declare’ and CE mark your product, the process can seem somewhat convoluted and confusing if you are unfamiliar with the process. Physically attaching a CE label may appear to be very simple, but the CE mark is the culmination of a process of assessment and validation.
What is the difference between Directives and Regulations?
CE Marking is a certification mark that shows compliance with the relevant health, safety and environmental regulations for products sold or used in the European Union.
How do I show compliance with a Directive or Regulation?
To ‘show’ you have complied with a directive you should apply the CE mark in accordance with the guidance in the directive. Some directives require the issue of a support document (Declaration of Conformity, as an example) and these should be considered a legal statement made by the manufacturer prior to placement on the market. There are additional considerations for Importers and specialist product labelling, but as a ‘general rule of thumb’ the minimum they all require CE marking.
How do I identify which Directive a product applies to?
CE Marking is a certification mark that shows compliance with the relevant health, safety and environmental regulations for products sold or used in the European Union.
What is a European Directive?
A Directive is an EU legislative act that sets out a goal that all EU member states must achieve. (It is up to the individual countries to devise their own laws on how to reach these goals). The EU has issued Directives covering hundreds of subjects, most of which do not require the use of the CE Mark. Those Directives that do require the use of the CE Mark are commonly described as New Legislative Framework or NLF Directives.
What is a Notified Body?
An organisation designated by an EU country to assess the conformity of certain products before being placed on the market. These bodies carry out tasks related to conformity assessment procedures set out in the applicable legislation, when a third party is required. The term ‘Notified’ comes from the fact that EU Member States mustnotify the European Commission when they accredit an organisation to undertake conformity assessments.
What is a UKCA Mark?
The UKCA Mark (UK Conformity Assessment Mark), is used to demonstrate that a product conforms to applicable regulations on the GB Market (England, Scotland and Wales). It was not intended for the Northern Ireland market place.
It should be emphasised that some market sectors have their own particular requirements when it comes to the use of the UKCA mark. Please ensure that you review the industry sector list on the UK Government website.
What is an Approved Body?
An Approved Body is an organisation designated to assess the conformity of products before they are placed on the market in the UK. Some regulations require substantial involvement from Approved Bodies for most products, whilst for other regulations the use of anApproved Body remains entirely voluntary.
Do I need a Notified/Approved Body?
This will depend on the Directive/Regulation(s) that is/are applicable to a Product.
Some Directives, such as the Low Voltage Directive 2014/35/EU, never require the use of a Notified Body, whilst others, such as the Machinery Directive, only mandate the involvement of an Notified Body in limited and very specific circumstances. However, when applying some Directives, such as the ATEX Directive 2014/34/EU, the involvement of a Notified Body will be required in the majority of circumstances.
How do I know if my product needs to be CE marked?
For a definitive list of applicable products for the European market you would need to check the Europa website foundhere.
How Can Technology International Help?
Whatever a client’s individual requirements Technology International offer a flexible approach to how we provide our services, allowing you and your team the ease of our input into the specifics of the Machinery Directive, as if we were one of the team.
Why work with Technology International?
Technology International’s goal is to simplify and guide our customer confidently through the complicated process of UKCA / CE Marking and other Regulations from start to finish.
Approved Body for Machinery, Electromagnetic Compatibility and Radio Equipment Regulations.
We have been a presence in the Regulatory Compliance industry for over 30 years and have worked on over 10,000 compliance projects worldwide.
We are committed to an ethical, bespoke and consultative approach to all our customers.
