Authorised Representative / Responsible Person Service
Under Articles 10 & 16 of the General Product Safety Regulation (EU) 2023/988
What is the General Product Safety Regulation?
The General Product Safety Regulation (GPSR) is new EU legislation replacing the general product safety directive (GPSD).
The GPSR requires that all consumer products placed on the EU market are safe and creates specific obligations for manufacturers and associated economic operators to ensure products are safe.
The GPSR applies to non-food products and provides a regulatory framework for products and risks not covered by existing EU legislation, with the emphasis placed on consumer safety, protecting them from dangerous products.
This new regulation aims to:
- Ensure product safety including consideration to new technologies.
- With the shift and growth of online sales such as Amazon, address the challenges.
- Provide better enforcement of the rules and market surveillance activities.
- Improve the effectiveness the product recall system.
Published in the Official Journal of the European Union on May 23rd, 2023, the GPSR entered into force on June 12th, 2023. However, it becomes mandatory December 13th, 2024.
For more information from the European Commission please visit their webpage on GPSR. And for the GPSR factsheet.
Which Products are Covered by the GPSR?
Pursuant to Article 2(1):
This Regulation applies to products that are placed or made available on the market insofar as there are no specific provisions with the same objective under Union law which regulate the safety of the products concerned
Where products are subject to specific safety requirements imposed by Union law, this Regulation applies only to those aspects and risks or categories of risks which are not covered by those requirements.
In essence this means consumer products in general (non-food products) not covered by existing EU legislation. Where harmonised standards may or may not exist. The following are some examples of consumer goods that would fall within the GPSR (this is not an exhaustive list):
- Children’s articles, such as cots, prams, highchairs and bunk beds.
- Bicycles.
- Gym equipment.
- Household goods, such as crockery, cutlery and cooking utensils.
- Gardening tools.
- Furniture and soft furnishings.
- Clothing.
- Candles and other ornaments.
- Hobby and art materials.
It’s a Mandatory Requirement.
The appointment of an article 16 Responsible Person is a mandatory requirement for manufacturers of product under the GPSR who are also located outside the EU who wish to sell and place products under the GPSR on the EU market.
Products covered by the GPSR shall not be placed on the EU market unless there is a Responsible Person within an economic operator established in the EU in accordance with article 16(1) of the GPSR. And the obligations of article 16(2) (a) & (b) have been met.
It’s a Critically Important Regulatory Role.
The role of an article 16 Responsible Person is new and is critically important and plays a pivotal role in ensuring compliance of products produced by manufacturers who are located outside the EU and serves as their contact person established in the EU.
Together with the authorised representatives’ responsibilities in article 10 of the GPSR our service outlines enhanced obligations. That the EU deem 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 / Responsible Person Service goes beyond the obligations of Article 10 & 16 of the GPSR. 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.
- Carry out its obligations as set-out in Article 10 of the GPSR.
- Keep on file a copy of your full technical documentation for inspection by EU regulators, upon request.
- Provide support and assistance with market surveillance and help manufacturers understand their obligations concerning reporting in accordance with EU regulations.
- Carry out its obligation as set-out and verify the manufacturers documentation in accordance with Article 16.
- Carry out regular checks in accordance with Article 16(2), point (a) and (b) of the GPSR.
- Document and record the checks performed and retain at the disposal of EU Competent Authorities/Market Surveillance Authorities.
- 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.
