What is a UK Responsible Person?
In the context of product compliance, a Responsible Person (RP) is an individual or a business entity that acts as an authorised point of contact on behalf of a manufacturer that is based outside of the country for which the product is being sold (or placed on the market in most cases, even if a sale is not involved).
Comply Express provides the ‘UK Responsible Person’ (UK RP) service to customers outside the UK, licencing its Comply Express Ltd name and UK office contact details for use as part of a service to act on behalf of the client company located outside of the UK.
Is it mandatory to appoint a UK Responsible Person?
Under the UK MDR 2002 manufacturers based outside the UK that place medical devices, including in vitro diagnostic medical devices (IVDs), on the Great Britain market (England, Scotland and Wales), must appoint a UK responsible person.
Distributors and Importers are not required to appoint a UK responsible person.
Listed below are a few obligations of a UK RP, for the full list of obligations see the UK MDR 2002:
- Ensure that the declaration of conformity and technical documentation have been drawn up and, where applicable, that an appropriate conformity assessment procedure has been carried out by the manufacturer.
- In response to MHRA requests, provide the MHRA with all relevant technical documentation to demonstrate and provide evidence of conformity compliance.
- Cooperate with the MHRA on any preventative or corrective action taken to mitigate the risks posed by the device.
- Comply with device registration obligations with the MHRA.
MHRA Registration
The Medicines Healthcare products Regulatory Agency (MHRA) forms part of the UK’s Department of Health. The primary purpose of the MHRA is to regulate the medical industry to ensure that medical devices placed on the Great Britian market meet the required quality and safety standards. The MHRA carries out market surveillance of medical devices for the Great Britain market. Medical device monitoring performed by the MHRA determines decisions regarding the supply of devices into the UK market.
Manufacturers wishing to place their medical devices on the UK market are required to register them with the MHRA. Registration with the MHRA is mandatory!
Where manufacturers are based outside the UK, a UK Responsible Person must be appointed to act on the manufacturer’s behalf to register the devices.
UKCA marking & CE marking for Medical Devices
The UKCA mark is the UK certification mark required to be affixed to products that fall under the scope of the relevant UK Statutory Instruments. These requirements are very similar to the CE marking requirements previously used and well known by many businesses.
The CE mark is currently still accepted as a recognised certification mark for medical devices on the UK market. However, there are restrictions on which devices the CE mark is accepted for.
The transitional arrangements extending the acceptance of CE marked medical devices in Great Britain depend on the device type/classification and the directive/regulation it has been certified to. More information can be found on the UK Government website.
Please be aware that transitional timelines are subject to change.
Our UKRP service
Comply Express Ltd offers a UK RP service to customers outside of the UK, licencing its name and UK contact details for use accordingly. We will act on your behalf to register your certified devices with the MHRA.
Whether you have 1, 100 or 1000+ products / product variants to place on the UK market, we can assist you and act as your UK Responsible Person.
Why choose Comply Express to be your UKRP?
- Highly experienced team of compliance engineers
- Simple and streamlined registration process
- Cost-effective service
- Comply Express Ltd is backed by professional indemnity insurance
Additional Support and Services
Need help with your technical file, declaration of conformity or product labelling? Our team of compliance engineers can assist you with the documentation your product needs to meet market regulations.
Product Compliance Management – Our SmartCert software guides you through the compliance journey. From identifying the applicable legislation to on-going legislative monitoring to ensure updates and changes are not missed- preventing common mistakes that could have serious consequences.
Visit our features page for more information.
We provide the EU Authorised Representative Service for manufacturers based outside of the EU placing goods on the EU market.
Visit our EU Authorised Representative page for more information.
FAQ
What is a UKRP?
Do I need a UKRP?
Can I use an Authorised Representative to place products onto the Great Britian market?
How do I get started?
Simply contact Comply Express by email or phone to enquire further