Last week’s blogpost discussed what an Authorised Representative (AR) does and what they can do for a manufacturer who is based outside of the EU. Because this was rather specific to EU context, this blogpost will look at the concept of an AR within UK context. For the UK market, the term AR is not applicable: we speak of a Responsible Person (RP). A manufacturer based outside of the UK who sells on the UK market can appoint an RP to help ensure a safe and legal trading process. The UK market here refers to the product market of England, Wales, and Scotland – notice that Northern Ireland is excluded. Another blog will soon be devoted to Northern Ireland’s position within all this, but today’s blog will answer your questions about UKRPs.
Brexit: from EU AR to UKRP
Because the UK has left the EU, the EU legislation on product safety and trade does not apply to the UK market anymore. The UK is thus free to draw up new regulations that might complicate the process of trading on the UK market for manufacturers who are based outside of it. Where the EU and Northern Ireland adhere to the Market Surveillance Regulation 2019/1020, the UK has not implemented this regulation and rather sticks to requirements as disclosed in the New Legislative Framework (NLF) Regulation EC 765/2008. Besides that, the EU regulations have been adopted without revision, meaning that currently the same legislation applies both within the EU and the UK. The main differences right now come down to mere terminology and market-specific product marking:
- EU AR à UKRP
- EU Single Market legislation à UK domestic product safety legislation
- CE marking à UKCA (United Kingdom Conformity Assessed) marking – click here to find out the difference between these two
The UK is now considered a ‘third country’ by the EU, so for manufacturers based in the UK who want to trade on the EU market, it is best to assign an EU AR. Likewise, for manufacturers who are based outside of the UK and who want to sell on the UK market, appointing a UKRP is either mandatory or strongly preferred. To get in touch with a UKRP with expertise in UKCA marking, click here.
What is a UKRP?
An RP is thus essentially the same as an AR only specific to the UK market: it is a legal party based within the UK that acts as a liaison between a manufacturer outside of the UK and competent national authorities within the UK. An RP can be appointed by manufacturers who sell their products:
- Online (via e-commerce)
- Through a fulfilment service provider
They act on behalf of the non-UK manufacturer to carry out specified tasks that were part of the manufacturer’s obligations before outsourcing them to an RP. These responsibilities are disclosed in the UK MDR 2002 and include but are not limited to:
- Reviewing UKCA marking
- Drawing up the UK Declaration of Conformity and ensuring this and other technical files are available to the local market authorities
- Answering of questions from local authorities and advice the manufacturer about possible requests from said authorities
The conditions on which the partnership between the manufacturer and the UKRP is established should be documented in an official mandate. The mandate should include all of the tasks delegated to the RP, as well as the tasks that cannot be outsourced and remain a responsibility of the manufacturer. An example of this is the verification concerning the requirements of the QMS (Quality Management System) of a manufacturer.
The UKRP’s duty.
A UKRP fulfils all of the tasks that are listed in the mandate. The following summary shows the very basics responsibilities that the RP adopt from the manufacturer.
- Informing the manufacturer when a competent authority makes a valid request concerning the conformity of products
- Notifying authorities when there is reason to believe that a product presents a risk and cooperating with them to eliminate that risk
- Cooperating with the national surveillance authorities and making sure that the technical documentation is available to them, including the Declaration of Conformity
- In the event of any relevant dispute arising between Authorised Representative and a third party relating to the requirements of the Products, the AR shall notify the manufacturer of the dispute and shall attempt to resolve this dispute by providing all information, evidence, help and assistance which may be reasonably and/or mandatorily required
- Terminating the agreement if the manufacturer does not adhere to the obligation as stated in the relevant legislation
These and other tasks become mandatory for the RP to carry out once the mandate has been signed; the manufacturer is no longer allowed to concern themselves with the tasks as they have now officially outsourced them.
An important side note for manufacturers of Medical Devices: one more task should be included in the list above. For these manufacturers specifically, an RP needs to also verify that all the necessary information concerning their medical product will be registered in MHRA (Medicines and Healthcare products Regulatory Agency). This is the UK equivalent of EUDAMED. Another blog will soon follow to explain the services a UKRP can provide for manufacturers of Medical Devices.
Important when working with an RP.
Although it is preferable, having an RP is not mandatory for all manufacturers who want to trade their product on the UK market. A UK Economic Operator is required, but an importer or a Fulfilment Service Provider could also take on these responsibilities. Click here to be directed to the blogpost that sets apart for which manufacturers an RP is mandatory, and for which ones it is not.
It is mandatory for the same manufacturers that are required to appoint an RP to include both the address and contact information of the RP and themselves on the product and its packaging.
Another term to be aware of is who is obliged to sign the Declaration of Conformity. If the mandate states that RP’s details need to be provided, this is obligatory. Otherwise, it is not required for the RP to sign the Declaration, meaning that the manufacturer’s details must be provided instead.
Choosing the right RP.
There are multiple reasons why having an RP is in nearly all cases the best choice for a manufacturer (another blog will go deeper into these reasons soon). One of the most important reasons, however, is that appointing an RP prevents importers to have access to all of the manufacturer’s technical files, which includes documentation such as:
- CE test reports
- Instructions for use
- Design documents
- Declaration of Conformity (CE certificate)
Therefore, it is crucial to assign an RP that is not economically or commercially involved with the products. Likewise, it is important to choose a UKRP that has expertise in compliance, considering that they are the party that verifies the Declaration of Conformity and liaises between the manufacturer and market authorities. In this way, legal complications can be prevented and notifying the the manufacturer of compliance matters will only happen if it affects their product directly. A competent RP will be able to answer all question authorities can have and additionally advice you, as the manufacturer, accordingly.
If you are still looking for the right RP, click here to let us help you.
Stay tuned on our blog for more information on the advantages of having an RP and the role of RPs for manufacturers of Medical Devices.