Why do Manufacturers require a European Authorised Representative?
Legal background
In June 2023, the EU adopted the new Machinery Regulation (EU) 2023/1230, a directly applicable regulation aligning with the New Legislative Framework. This Regulation entered into force in July 2023 and will apply mandatory from 20 January 2027, repealing and replacing the Machinery Directive at that time.
Failure to comply may lead to serious consequences, including:
- Products being stopped at customs or removed from the EU market
- Corrective actions, withdrawals or recalls
- Loss of distribution channels and contractual disputes
- Administrative penalties and enforcement measures
- Reputational damage and long-term market access impacts
Our services
EU & UK Authorised Representative for Machinery Products
Obelis offers end-to-end regulatory support to verify that your machinery enters and remain in the EU and UK markets legally and successfully. As your Authorised Representative in the European Union and in the United Kingdom, we will:
- Guide you through the requirements of the Machinery Directive 2006/42/EC and the upcoming Machinery Regulation (EU) 2023/1230, ensuring your machinery, assemblies or partly completed machinery are correctly classified and compliant.
- Support in preparing and reviewing the technical documentation.
- Maintain your EU Declaration of Conformity (or Declaration of Incorporation, where applicable) and technical file for 10 years after the machinery is placed on the market.
- Monitor regulatory developments and provide post-market surveillance support, including assistance with corrective actions and authority requests.
- Represent your brand before EU Competent Authorities as Authorised Representative, ensuring clear, professional communication and minimising the impact of any compliance issues.
- With our trusted EU machinery representation, you gain a reliable compliance partner, supporting safe market access and protecting your business reputation.
FAQ
Frequently Asked Questions
Machinery placed on the EU market is currently regulated under the Machinery Directive 2006/42/EC, which sets essential health and safety requirements and CE marking obligations.
Manufacturers must prepare and keep technical documentation demonstrating compliance with the applicable essential health and safety requirements before placing machinery on the EU market.
Manufacturers must also draw up an EU Declaration of Conformity (or a Declaration of Incorporation for partly completed machinery) and affix the CE marking, where applicable.
The technical file must be kept available for market surveillance authorities for at least 10 years after the machinery has been placed on the market.
Working with Obelis means having a trusted regulatory partner with extensive experience in EU product compliance.
We support you throughout the compliance process, helping you correctly classify your machinery, prepare robust documentation and address regulatory requirements efficiently. Our practical, structured approach reduces compliance risks, avoids delays and supports long-term market access in the EU.
We support manufacturers in identifying the applicable conformity assessment procedure, reviewing technical documentation and ensuring that declarations and CE marking are correctly prepared.
Where the involvement of a Notified Body is required for certain categories of machinery, we help coordinate the process and align documentation with regulatory expectations.
