UKCA and CE Self-Certification with RiskMach
RiskMach offers a powerful tool that makes the product self-certification process required by UK and EU legislation easy. With our handy integrated software solution, you can complete the relevant conformity assessment procedure, ensure your product is compliant with the statutory industry standards of the intended market and gather all legally-required technical documentation, including a UK Declaration of Conformity or an EU Declaration of Conformity.
Manage all aspects of the self-certification process in one collaborative space
Almost all products that require a CE mark or a UKCA mark don’t require a third-party assessment. However, the self-certification procedure and requirements are different for each individual product, so it can be difficult to gather all relevant information and design the risk assessment right.
RiskMach has the capability to help you organise and execute all the key elements of the UKCA / CE self-certification process listed below:
- Conformity Planning – Plan and schedule a conformity assessment
- Design Risk Assessment – Identify risk and assess risk levels
- Selection of Protective Measures – Design and implement measures to ensure compliance
- Review at intervals to ensure verification and validation of protective measures is properly evidenced
- Conformity Assessment – Ensure compliance with all EU legislation, including the Machinery Directive. Organise records to the applicable essential health and safety requirements (EHSRs).
- Compile the technical construction file – Issue all records, including PDFs generated by RiskMach, to the RiskMach Vault where they are held for a minimum of 10 years.
- Certification Audit (Optional) – Record an audit of the technical construction file and the as-built machine to achieve a high level of confidence
- Certification (CE) – Draw up an EU Declaration of conformity for CE marking. If RiskMach vault is used then RiskMach is the named person holding the technical construction file in the EEA
- Certification (UK) – Draw up a UK Declaration of Conformity for UKCA marking. If RiskMach vault is used then RiskMach is the named person holding the technical construction file in the UK
What are the benefits for your business?
Any CE and UKCA certification project can get messy – it’s a complicated process but by introducing RiskMach to your team, you can ensure that at the end, you have demonstrated systematically that all foreseeable risks have been considered and reduced adequately within the limitations of the project.
Organise the chaos of Design Risk Assessment
Thanks to our comprehensive system, the three key parts of the Design Risk Assessment: information gathering, risk analysis and risk evaluation can be organised and kept track of as new information comes to light.
Build a flawless technical file
Keep records safe for at least 10 years
Frequently Asked Questions
Why do I need a UKCA mark?
From January 2021, many products sold on the GB market must have a UKCA mark to prove they are compliant with the relevant UK regulations. If your products were previously CE-marked chances are you will need UKCA certification.
Who is responsible for ensuring compliance with regulatory requirements?
Both CE certification and UKCA certification fall under the duties of the manufacturer, as it is your legal responsibility to ensure the safety of your products.
How long do I need to keep the documentation related to the certification process?
You must keep the Declaration of Conformity and the technical file for each product for a minimum of 10 years, as those could be requested by the relevant market authorities at any point. With RiskMach Vault these documents will be stored in a safe space for at least 10 years.
Why do I need a CE mark?
If you are a UK-based company that manufactures products for the EU or NI markets, you will need to comply with the EU health and safety standards. A CE mark indicates your products conform to those.
What products are covered by the CE and UKCA self-certification?
Almost all products subject to CE and UKCA regulations are available for self-certification. The list of exceptions is short and includes just 17 groups of risk machinery, some Class I medical devices and a few other individual products.