United Kingdom Market
UK Responsible Person (UKRP)
Medical Device
IVD
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What is UK Responsible Person?
A UK Responsible Person (UKRP) is a legal entity appointed by a manufacturer, based outside of the UK, to fulfil the obligations of the UK Responsible Person as per the UK Medical Device Regulations (UK-MDR) and In-Vitro Diagnostic Regulations (UK-IVDR). The UKRP ensures that the medical devices or in vitro diagnostic devices they represent comply with all regulatory requirements before they are placed on the UK market.
To appoint a UKRP, the manufacturer must be established outside of the UK and must not have a registered place of business in the UK. The manufacturer must provide the UKRP with all the relevant technical documentation and ensure that the UKRP has sufficient knowledge and experience to fulfill the role.
Why is UK Responsible Person important?
Assurance
Their involvement helps manufacturers navigate the complexities of the UK regulatory landscape and ensures that their products meet the necessary standards for safety, quality, and efficacy in the UK market.
Market Access
The UK Responsible Person (UKRP) plays a crucial role in ensuring compliance with regulatory requirements and facilitating market access for products in the UK.
Process Flow for UK Responsible Person
Understand UK Market Regulations: Familiarize yourself with the specific regulatory requirements for your product category in the UK market.
Identify Qualified UKRP Providers: Research and identify qualified UKRP providers who have experience and expertise in your industry.
Evaluate UKRP Services: Assess the services offered by different UKRP providers. Consider factors such as their knowledge of UK regulations, experience with your specific product category, support for regulatory submissions, and post-market surveillance capabilities.
Engage with a UKRP Provider: Initiate discussions and negotiations with the selected UKRP provider. Clarify their responsibilities, scope of services, and the terms of the agreement.
Register with the UKRP: Work closely with the UKRP provider to register your products with the relevant UK authorities.
Ensure Compliance with UK Regulations: Collaborate with the UKRP provider to ensure ongoing compliance with UK regulations. Regularly review and update product documentation, labeling, and packaging to meet the specific requirements of the UK market.
Post-Market Obligations: Seek guidance from the UKRP provider on fulfilling post-market obligations, such as vigilance reporting, product updates, and communication with regulatory authorities.
Communication with Authorities: Utilize the expertise of the UKRP provider to facilitate effective communication with the relevant UK regulatory authorities.
Stay Updated on Regulatory Changes: Continuously monitor the requirements set by the UK authorities and work closely with your UKRP provider to adapt your strategies and compliance efforts accordingly.
How can we help in UK Responsible Person?
The CliniExperts professionals will -
Assist in registration process.
Ensure that product comply with UK regulations and standards.
Provide guidance on adapting the product, labeling, or documentation to meet the changing regulations.
Regulatory requirements for UK Responsible Person
Timeline
The specific timeline for appointing a UKRP can vary depending on various factors, including the type of medical device, the regulatory pathway used to place the device on the UK market, and the transition arrangements in place for existing devices.
Regulatory Body
The regulatory body responsible for overseeing the UKRP role and the UK medical device regulations is the Medicines and Healthcare products Regulatory Agency (MHRA).
Fees
The specific timeline for appointing a UKRP can vary depending on various factors, including the type of medical device, the regulatory pathway used to place the device on the UK market, and the transition arrangements in place for existing devices.
Validity
The validity of the UKRP role is tied to the validity of the medical device’s presence on the UK market and compliance with the regulatory requirements.
