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UK Responsible Person For Medical Devices

Are You a Foreign Device Manufacturer wanting to sell your devices in the UK Market? Then This message is for you! Post the Brexit and Amendment of MDR (2019),A UKRP (United Kingdom Responsible Person) is a designated person (organization) that can help you in achieving the essential MHRA (Medicines and Healthcare Products Regulatory Agency) certifications before you can export your medical devices to the United Kingdom.

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What is UK Responsible Person?

According to the UK MDR 2019, the UKRP is defined as “a person based in the United Kingdom who acts on behalf of a foreign manufacturer located outside the United Kingdom in relation to the manufacturer’s obligations under the regulations.

The UKRP serves as the UK’s equivalent to the EU authorized representative, with the role of the authorized representative no longer applicable in the United Kingdom.

It is essential that a medical device is placed on the I-JK market by either the manufacturer or a recognized UKRP.

To validate this arrangement, documentary evidence in the form of a mutually signed agreement (letter of designation) between the manufacturer and the UK Responsible Person is required. This agreement should include the names and addresses of both the overseas manufacturer and the UKRP, demonstrating that the UKRP is authorized by the manufacturer and that the devices comply with all relevant laws. The MHRA, on September 18, 2019, published new guidelines outlining the role and responsibilities of the UKRP in regulating medical devices after Brexit.

Why CERT3Global Deserves to be your UKRP Partner ?

  • We offer Complete UKRP Services to ensure our clients can sell their Medical Devices in the UK Market in a seamless way.Our services are not limited to Clerical or Transactional Partnership,but we offer end to end solutions at every step of the process.

  • We have been in the market since 1999, our team comprises highly experienced Medical Device regulatory professionals National Representatives of seven countries who have the expertise to handle complicated devices and their regulatory aspects.

  • In addition to UKRP Services, we offer:
    -support for UKCA Technical Documentation
    -Clinical Evaluation,Biological Evaluation,
    -Certification Body Coordination,
    -end to end solution for certification and compliance
    -ISO 13458 implementation and
    -MHRA Registration services.

  • For a smooth Business experience with us we offer multiple Payment Options, which gives you the flexibility to Pay according to your chosen Payment Method.

  • Team CERT-3 Global is a result driven,customer focused consultancy service. Having the experience of assisting numerous companies over the years gives us the ability to personalize and customize the service we offer to our clients. We Look forward to a fruitful association with you. You can send us a message or reach out to us directly on call. We are eager to help you.

Roles And Responsibilities Of UKRP

  • Identification of appropriate GMDN Code at no additional charge.
  • Collaboration with associated laboratories for biocompatibility and safety testing in multiple countries.
  • Critical Investigation ,Evaluation and risk analysis of the device.
  • Assisting with correct medical device classification.
  • Ensuring the manufacturer follows the appropriate conformity assessment procedure.
  • Maintaining the latest technical documentation and records of the manufacturer.
  • Providing the MHRA (Medicines and Healthcare Products Regulatory Agency) with requested information and documentation.
  • Coordinating with the manufacturer in case of sample requests or device inquiries from the MHRA.
  • Cooperating with the MHRA to implement any corrective and preventive actions (CAPA) to mitigate potential risks.
  • Promptly informing the manufacturer about field incidents and complaints. Monitoring the manufacturer’s compliance with obligations under the MHRA Regulations.
  • Notifying the MHRA and terminating the UKRP relationship with the manufacturer, if necessary.
  • Opening a single registration account on behalf of the manufacturers we represent.
  • Supporting Post-Market Surveillance (PMS) activities.
  • MHRA Registration is Mandatory for Medical Devices and IVDs.

Required Details for MHRA Registration of Medical Devices and IVDs

To bring your medical device or (IVD) in-vitro diagnostic device to the UK market, Medicines and Healthcare Products Regulatory Agency ( MHRA) Registration is a non-negotiable requirement.

 

Here are the Information Essential for MHRA Registration Process :

 

Manufacturer (Facility) Information:

 

  • Legal manufacturer’s name, address, contact details (phone, email).
  • Description of activities conducted by the legal manufacturer.
  • Name, Email of the person responsible for communication with MHRA.
  • A mutually Signed agreement between legal manufacturer and the UK Responsible person

 

Medical Device Information:

  • Regulations applicable to the device.
  • Device’s risk classification.
  • Global Medical Device Nomenclature (GMDN) Code.
  • Basic Unique Device Identifier (UDI-DI).
  • Brand/trade name of the device.
  • Device model or versions.
  • Reference number of Instructions for Use (IFU), User
  • Manual, or Catalog.
  • Name and address of UK Approved Body or Notified
  • Body (excluding Class I devices).
  • Sterilization type (if applicable).
  • Details regarding Latex and phthalates.
  • MRI compatibility information for the device.

Who can be a UK Responsible Person ?

Any third party entity/individual who is established in the UK and acts ‘on behalf of’ foreign manufacturers to register their (manufacturer’s) medical devices and IVD (In Vitro Diagnostic Devices) with MHRA(Medicines and Healthcare Products Regulatory Agency).

A UKRP must :
(i)have a registered place of business in UK
(ii)be able to address local grievances
(iii)be physically present in UK where technical documentation related to the product shall be maintained
(iv)be registered with MHRA
(v)ensure that conformity assessment of the device has been completed by the manufacturer.

A UKRP is essentially an Authorized Representative for manufacturers of Medical Devices and will generally fulfill the same role in accordance with the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR)