CE Marking Self-Certification with RiskMach
Are you manufacturing or exporting products for the EU or NI markets? Avoid the legislative pitfalls of the CE marking self-certification process with the help of RiskMach Certification – your all-in-one, digital cloud-hosted certification software. Experience the power of our collaborative platform which gives you access to the hazard, task location (HTL) manager that together with the protective measures and technical file manager gives you a one stop shop certification solution. The secure Cloud storage for your technical file and Declaration of Conformity will have you sailing through the administrative burden of your certification procedure.
Do you need CE certification?
If you are a UK manufacturer or exporter who supplies products to be sold on the EU or NI markets, you are legally required to conform with all relevant EU regulatory directives. To achieve that, the CE certification marking must be attached to each of your products to indicate that its conformity has been verified.
RiskMach Certification is designed to help you streamline the self-certification process, allowing you to ensure compliance with all relevant industry standards and directives, without having to hire a third-party compliance assessor to do the CE mark certification (where self-certification is applicable). Alternatively, you could use external consultants but have them working in your company area in RiskMach giving you perfect oversight and capturing all the important tweaks and changes to important records like your Design Risk Assessment.
How do I self-certify for CE?
In most cases, you can do the CE marking certification yourself (except when the applicable directives indicate otherwise). However, the CE self-certification process can be confusing, as it can vary for different products. That being said, there are a few general steps you should always follow when you self-certify a product for the CE marking:
- Identify the relevant CE marking directives & harmonised or designated standards
- Design to applicable standards or explain any deviations
- Internal checks to identify gaps in compliance
- Affix the CE certification mark to the product
- Complete and sign a Declaration of Conformity (or other relevant declaration)
- Compile a Technical File & store it for at least 10 years
How can RiskMach Certification help?
What makes the CE marking self-certification process difficult is that you need to have an in-depth knowledge of all industry standards and directives applicable to the specific product you are assessing.
RiskMach Certification makes that process simple by giving you all the tools you need to perform the conformity assessment and design risk assessment process for any product certification directives or regulations.
The Declaration of Conformity along with the rest of the technical file is compiled and stored in our secure cloud-based Certification Vault. Your technical file is safely held by RiskMach for at least 10 years with RiskMach acting as the named person on the declaration of conformity giving you access to both NI and EU markets.
Identify & Monitor CE Regulations and Directives
Get full visibility of all relevant CE certification regulations and requirements & monitor for changes to the directives that apply to your product.
Impeccable Compliance Assessment
From planning a conformity assessment to identifying, assessing and reducing risks by safe design, you have all the tools to ensure regulatory compliance.
EU Declaration of Conformity
Complete the CE marking self-certification process with an automated Declaration of Conformity, and save it in the RiskMach Vault for 10 years.
Named Person Holding the Technical File
RiskMach is able to hold your technical file in the target market that you have identified for your product further helping you to grow your business whilst minimising the compliance burden ongoing.
Frequently Asked Questions
If you are manufacturing or exporting your product to the EU or NI markets and that product falls under the New Approach Directives, you are required to have CE certification to demonstrate conformity with the EU safety standards and regulations.
Yes, nearly 90% of all products are eligible for CE marking self-certification. Consult with the relevant compliance regulations and directives to find out whether your product can be self-certified or not.
Yes, as it stands, UKCA is completely aligned to CE with only administrative reference differences in real terms. However, over time this may change as either the UK or the EU change their requirements.
You need to find which UK regulations and/or EU regulatory directives are relevant to your product, carry out a conformity assessment, identify and assess risks, recertify them and ensure compliance, all before affixing the CE marking. You also have to compile all relevant documentation, including a CE Declaration of Conformity, in a Technical File which you are legally required to keep for at least 10 years. If you are not sure how to go about this then consider using an expert to support you.
This is when you, as the manufacturer, perform the certification process, including the conformity assessment, by yourself. RiskMach Certification is designed to support you throughout the CE self-certification procedure.
The cost of CE marking is different for different products. For example, CE marking machinery in the UK varies depending on the machine assessed and whether there are major non-conformities that need to be rectified, so it can go from £1,500 to £4,000 per machine for expert support. There will also need to be internal resources applied to provide the required evidence to put in the technical file.