UK Responsible Person

Taylored Consultancy Ltd offer comprehensive UK Responsible Person (UKRP) services to ensure your company and brand are compliant with UK MDR 2002.

But what does this mean?

In the landscape of consumer safety and regulatory compliance, the UK Responsible Person plays a pivotal role in ensuring that products placed on the market meet the necessary standards and requirements.

If you are a medical devices manufacturer based outside the UK and wish to place a device on the Great Britain market, you need to appoint a single UK Responsible Person (UKRP) for all your devices. This UKRP will act on your behalf to carry out specified tasks as per the UKRP responsibilities.

The Essential Role of the UK Responsible Person:

At its core, the UK Responsible Person serves as a bridge between manufacturers based outside of the UK and regulatory authorities, assuming responsibility for the compliance of products with applicable regulations and standards.

Responsibilities of the UK Responsible Person:

The responsibilities of the UK Responsible Person are set out in the UK MDR 2002. In summary, in addition to the above registration requirements, the UK Responsible Person must:

·       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

·       keep available a copy of the technical documentation, a copy of the declaration of conformity and, if applicable, a copy of the relevant certificate, including any amendments and supplements for inspection by the MHRA

·       in response to a request from the MHRA, provide the MHRA with all the information and documentation necessary to demonstrate the conformity of a device

·       where they have samples of the devices or access to the device, comply with any request from the MHRA to provide such samples or access to the device

·       where they have neither samples of the device nor access to the device, communicate to the manufacturer any request from the MHRA to provide such samples or access, and communicate to the MHRA whether the manufacturer intends to comply with that request

·       cooperate with the MHRA on any preventive or corrective action taken to eliminate or, if that is not possible, mitigate the risks posed by devices

·       immediately inform the manufacturer about complaints and reports from healthcare professionals, patients and users about suspected incidents related to a device for which they have been appointed

·       if the manufacturer acts contrary to its obligations under these Regulations:

o   terminate the legal relationship with the manufacturer; and

o   inform the MHRA and, if applicable, the relevant Approved Body of that termination.

Registration:

The MHRA will only accept registration of devices from manufacturers where the manufacturer is based in the UK. If the manufacturer is based outside of the UK, a UKRP is required as detailed above. One of the responsibilities of the UKRP is to complete the registration of the device with the MHRA, as detailed above.

So now you understand when a UKRP is required, why a required UKRP is required and the responsibilities of the UKRP, what are the next steps…

Determine your partner:

Taylored Consultancy work with a wide range of medical device manufacturers appointed as UKRP to enable the sale across Great Britain. Reach out to us and we can discuss the following steps in more detail, providing you with a statement of work and quotation.

Compliance Check:

Taylored Consultancy will provide you with a ‘UKRP Checklist’. This requests from the manufacture a list of documents to be reviewed to ensure the products to be registered with the MHRA are compliant to UK MDR 2022. If any gaps are picked up during this compliance review, Taylored Consultancy can support you with generating these documents prior to registration.

How do I appoint a UKRP?

Once the compliance check is complete, it is time to assign your UKRP. The UK Responsible Person must provide written evidence that they have the manufacturer’s authority to act as their UK Responsible Person. Taylored Consultancy will provide you with a template to complete this activity, called a ‘Letter of Designation’. This will assign Taylored Consultancy as your UKRP.

Registration:

Taylored Consultancy will now complete the registration for the devices detailed in the scope of work. Once approval is received from the MHRA this will be shared with the manufacturer to enable you to start selling or continue to sell.

Ongoing Compliance:

Taylored Consultancy will keep up to date with medical device legislation in the UK to ensure your products remain compliant and remain on the market.

What’s next… Reach out and ask any further questions about UKRP and we can start working together!