UK +441322413787  |  USA +13612472831  |  EU +35319643047

enquiry@cert3global.com

We are a group of professionals & device regulatory experts

The obstacles on the way can only be avoided if the guide is familiar with the matter!

REQUEST PROPOSAL

Post Approval Changes

Prior approval from the license holder must be obtained for major changes and notification from the national or central licensing authority is required for any minor changes as per Annex 6 of the Indian MDR.

 

Read more

Medical Device QMS

The manufacturing facility must comply with the Quality Management System requirements of India’s 5th MDR program, which is required for the manufacture of medical devices of the same quality.

 

Read More

Indian Agent

The Authorized Agent acts as the official agent of Import License in India and submits all required documents as specified in the Fourth Schedule for Medical Device Import License.

Read more

Understanding the UK Responsible Person (UKRP)

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UKRP serves as the UK’s equivalent to the EU authorized representative, with the role of the authorized representative no longer applicable in the United Kingdom. The UK MDR 2002, as amended by the UK MDR 2019, provides detailed information about the UKRP’s responsibilities.

 

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.” It is essential that a medical device is placed on the UK 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.

Cert3Global UK Responsible Person Service

As experienced medical device regulatory professionals and national representatives for seven countries, we offer comprehensive UKRP services through our UK headquarters. Our expertise extends beyond administrative tasks, providing a range of services to medical device manufacturers worldwide since 1999. Our clients can be confident in their success.

 

In addition to UKRP services, we offer support for UKCA Technical Documentation, Clinical Evaluation, Biological Evaluation, Certification Body coordination, ISO 13485 Implementation, and MHRA registration services.

 

Our team comprises experienced consultants, regulatory experts, and auditors who possess the ability to comprehend complex device regulations and offer expert opinions and advice. We are not limited to UK Responsible Person services; we provide end-to-end solutions for certification and compliance. Our friendly team maintains multiple payment options from various countries to facilitate smooth business relationships.

UK Responsible Person Roles and Responsibilities

  • Identification of appropriate GMDN Code at no additional charge.
  • Collaboration with associated laboratories for biocompatibility and safety testing in multiple countries.
  • Clinical investigation, clinical evaluation, and risk analysis.
  • 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 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.

MHRA Registration is Mandatory For Medical Device & IVD’s

To sell, lease, rent, or exchange your medical device or in-vitro diagnostic device on the UK market, you must obtain MHRA Registration. It is essential to make arrangements to register with the Medicines and Healthcare Products Regulatory Agency (MHRA).

Manufacturer (Facility) Information:

 

To complete the MHRA registration process, the following information regarding the manufacturer (facility) is required:

 

  1. Legal manufacturer’s name, address, designation, telephone, and email.
  2. Description of the activities carried out by the legal manufacturer.
  3. Name, email, and contact information of the person responsible for communicating with the MHRA.
  4. A mutually signed agreement between the legal manufacturer and the UK Responsible Person.

 

B. Medical Device Information:

 

In order to complete the MHRA registration process, the following information regarding the medical device is required:

 

  1. Applicable Regulation(s) for the device.
  2. Device Risk Classification.
  3. GMDN (Global Medical Device Nomenclature) Code applicable to the device in scope.
  4. Basic UDI-DI (Unique Device Identifier – Device Identifier) (Note: Currently not enforced, but will soon come into effect).
  5. Medical device brand/trade or proprietary name.
  6. Device model or versions.
  7. Reference number of the Instructions for Use (IFU), User Manual, or Catalogue.
  8. Name and address of the UK Approved Body or Notified Body for all classes, except for Class I.
  9. Type of Sterilization, if applicable.
  10. Details regarding Latex and phthalates.
  11. Medical Device MRI compatibility issues.
  12. Conformity assessment certificates.
  13. Declaration of Conformity, signed and dated.
  14. Latest revision number with the date of the Technical File.

 

Please ensure that all the above information is provided accurately for a smooth MHRA Registration process.

One year after your registration application or confirmation was made and then every two years after that, your MHRA registration must be renewed. Failure to renew your registration will cause our database to remove your records, at which point you will need to submit a new registration application in order to continue selling your device in the UK.