UK MHRA RG2 Registration Form 2013 free printable template

It may also help us if a picture or technical diagram of the device is also provided in addition to the completed registration form. Please also provide a general/generic description name for the product s you wish to register. You should avoid specific brand names or devices types as any changes to the registration details held incurs payment of our statutory fee. Note the MHRA will not accept a product catalogue/brochure as a means of application for registration. The MHRA generic device...

How to fill out UK MHRA RG2 Registration Form

How to fill out UK MHRA RG2 Registration Form

1. Download the UK MHRA RG2 Registration Form from the official MHRA website.
2. Fill in the applicant's details, including name, contact information, and organization.
3. Provide details about the product, including its name, purpose, and classification.
4. Include information about the manufacturer and any distributors involved.
5. Supply evidence of compliance with relevant regulations, such as technical documentation.
6. Sign and date the form at the specified section to confirm the information is accurate.
7. Submit the completed form along with any required supporting documents to the MHRA.

Who needs UK MHRA RG2 Registration Form?

1. Manufacturers or importers of medical devices and in vitro diagnostic devices that wish to place products on the UK market.
2. Companies seeking to obtain regulatory approval for medical products in the UK.
3. Organizations involved in the research and development of new medical technologies.

People Also Ask about

How do I register with MHRA UK?

Apply to register on the Device Online Registration System (DORS) You need to create an account on the MHRA DORS before you can start registering your devices. We will email you to confirm if your account request has been accepted or rejected.

How is MHRA approval for medical devices?

The U.K. MHRA medical and IVD device approval process explained Determine the classification of your device ing to the MHRA's adopted classification rules. Depending on your device classification, determine the appropriate conformity assessment route and implement a compliant quality management system (QMS).

What is the purpose of the MHRA?

The Medicines and Healthcare products Regulatory Agency regulates medicines, medical devices and blood components for transfusion in the UK. MHRA is an executive agency, sponsored by the Department of Health and Social Care.

How do I get MHRA approval?

User submits application for coordinated review by REC, MHRA and study wide review and receives a response or request for further information within 30 days. User responds to request for further information within 14 days. REC and MHRA provide final responses within 16 days.

What needs MHRA approval?

a Clinical Investigation or other study of a Medical Device. a combined trial of an Investigational Medicinal Product and an Investigational Medical Device. a Clinical Trial to study a novel intervention or randomised Clinical Trial to compare interventions in clinical practice.

What is MHRA approval?

The MHRA makes sure that any medicine or medical device is safe to use, and it meets the required quality and regulatory standards. A medical device can be anything from a plaster to an asthma inhaler or a ventilator used within a hospital setting.

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What is UK MHRA RG2 Registration Form?

The UK MHRA RG2 Registration Form is a document required by the UK Medicines and Healthcare products Regulatory Agency (MHRA) for the registration of certain clinical trials and studies involving human participants.

Who is required to file UK MHRA RG2 Registration Form?

Researchers and organizations conducting clinical trials or studies involving human subjects in the UK, particularly those that require MHRA approval, are required to file the UK MHRA RG2 Registration Form.

How to fill out UK MHRA RG2 Registration Form?

To fill out the UK MHRA RG2 Registration Form, one must provide detailed information about the trial, including the study title, objectives, methodology, participant information, and any investigational medicinal products used. Clear instructions and guidelines are provided by the MHRA.

What is the purpose of UK MHRA RG2 Registration Form?

The purpose of the UK MHRA RG2 Registration Form is to ensure that all clinical trials conducted in the UK are registered in accordance with regulatory requirements, facilitating monitoring, safety assessment, and transparency in clinical research.

What information must be reported on UK MHRA RG2 Registration Form?

Information that must be reported includes the trial's identification number, sponsor details, study design, ethical considerations, assessment of risks and benefits, informed consent procedures, and data management plans.