Authorised Representative Service
Under Article 12 of the Machinery Regulation (EU) 2023/1230 & Article 4(3) of Regulation (EU) 2019/1020
What is the Machinery Regulation?
The Machinery Regulation (EU) 2023/1230 sets out and promotes harmonisation through a combined approach of mandatory essential health and safety requirements and ‘voluntary’ harmonised standards considered to be state of the art.
This Regulation applies to machinery placed on the EU market or when existing machinery is modified to the extent it becomes new machinery.
For more information from the European Commission please visit their webpage on machinery.
Which Products are Covered by the Machinery Regulation?
The Machinery Regulation applies to a broad spectrum of machinery and related products. Specifically, it covers machinery, interchangeable equipment, safety components (including software), lifting accessories, chains, ropes, webbing, and removable mechanical transmission devices. For more details, please refer to Article 2 of the Machinery Regulation.
It’s a Mandatory Requirement.
Since it is now compulsory to include regulation (EU) 2019/1020 within the scope of the Machinery Regulation, Article 4(3) of regulation (EU) 2019/1020 makes it mandatory for a manufacturer located outside the EU to appoint an economic operator such as an Authorised Representative.
Products covered by the Machinery Regulation, including Regulation (EU) 2019/1020, shall not be placed on the EU market unless an economic operator in accordance with Article 4(3) established in the EU is appointed.
It’s a Critically Important Regulatory Role.
The Authorised Representative Service offered by Advena plays a pivotal role in ensuring compliance of Machinery produced by manufacturers who are located outside the EU and serves as their contact person established in the EU.
Article 12 of the Machinery Regulation & Article 4(3) of Regulation (EU) 2019/1020 outlines the obligations of our authorised representative service, that the EU deems to be critically important.
Experienced & Qualified
Advena has over 25 years’ experience as an authorised representative and employs qualified individuals who possess the necessary expert knowledge of the regulatory requirements. This knowledge is supported by academic qualifications and professional experience in regulatory affairs and quality management.
Appointing the Right Partner is Crucial
Advena’s Authorised Representative Service goes beyond the obligations of Article 12 of the Machinery Regulation & Article 4(3) of Regulation (EU) 2019/1020. We also help by providing client guidance, opinions, professional advice, all designed to help clients understand regulatory compliance.
We are also a founding member of the European Association of Authorised Representatives (EAAR).
In summary:
- Provide the manufacturer with a registered address in the EU, that is shown on their labelling packaging or IFU etc.
- Provide a point of contact between the manufacturer and EU Authorities.
- Verify that declarations of conformity and the technical documentation has been drawn up.
- Keep on file the Technical Documentation and the EU Declaration of Conformity of Machinery and related products or the EU Declaration of Incorporation of partly completed machinery at the disposal of national Market Surveillance Authorities.
- Provide information and documentation to competent authorities when requested to demonstrate conformity of Machinery covered in the authorised representatives mandate.
- Cooperate with competent authorities concerning requests to assist in the elimination of risks posed by Machinery covered in the authorised representative’s mandate.
- Provide support and assistance with market surveillance and help manufacturers understand their obligations concerning reporting in accordance with EU regulations.
- Carry out the obligations as detailed in Article 4(3) of Regulation (EU) 2019/1020 & mandate.
- Be available to consult with and support the manufacturer with issues regarding regulatory compliance.
Why Choose Advena as Your EU Authorised Representative?
Advena is one of the largest EC REP organisations within the EU. Representing a worldwide client portfolio. We offer a premium service at a competitive price, supporting clients to navigate the complex regulatory landscape in the EU.
- Over 25 years’ experience as an authorised representative.
- Experienced consultants to review your technical files.
- If you need consultancy support, we have the depth of experience you can rely on.
- If you need support and guidance with market surveillance issue, we are here to help.
- We are responsive, 90% of emails are replied to within 24-48 hours.
- We are available to answer questions & queries as part of our service.
- We offer a premium service at a competitive price.
Years of experience
With over 25 years of experience as an Authorised Representative Advena is the perfect choice for your business. It makes sense for you to engage with an experienced regulatory team. Our service has been developed to specifically support the needs of start-ups and small to medium sized manufacturers, to help them successfully enter the EU market.
Personal approach
We have a team of professional business administrators who provide a personal approach and place the needs of our clients at the very top of our priorities while also recognising that the applicable EU regulations must be complied with. Just take a look at our Client Testimonials page.
Great Responsive support
We also understand that clients need to be able to reach out for help and advice and how important being responsive is, Advena is committed to supporting our clients and is always available to answer client’s questions and queries, and this is included as standard in our service. In fact, our client feedback survey found that 90% of emails were replied to within 24-48 hours.
For More Information Concerning Our EU REP Service that
- Complies with EU Legislation
- Is certified to ISO13485.
- Is cost effective.
- Offers regulatory guidance and opinion.
- Answers your questions in a responsive manner.
- Allows you to benefit from our extensive experience and knowledge.
Contact us for a free quotation/proposal.
