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  • Mhra Registration Form (rg2) - Optical Confederation

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Guidance on Completing an RG2 Form for Medicines and Healthcare Products Regulatory Agency (MHRA) Registration This guidance has been developed for the optical sector in collaboration with the MHRA.

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How to fill out the MHRA Registration Form (RG2) - Optical Confederation online

This guide provides clear, step-by-step instructions for completing the MHRA Registration Form (RG2) online, specifically tailored for the optical sector. Our goal is to support all users in navigating the form efficiently and accurately.

Follow the steps to complete the MHRA Registration Form (RG2) online.

  1. Press the ‘Get Form’ button to access the MHRA Registration Form (RG2) and open it in your preferred document viewer.
  2. Carefully read the instructions provided on the form. This will give you an overview of what information is required and the structure of the document.
  3. Complete Part 1 of the form, selecting the appropriate category that reflects your business role, such as ‘Assembler of System and Procedure Packs’ or ‘Manufacturer’. Make sure to provide your registered place of business address.
  4. If applicable, proceed to Part 2, where you will specify details related to the devices you are registering, including generic codes for each type of medical device you supply.
  5. In Part 3, provide details for the payment of the registration fee. Ensure you include the payment verification if paying via debit or credit card.
  6. Review all entries for accuracy and completeness. Confirm that all sections of the form are filled out according to the guidance.
  7. Save your completed form. You can either download it to your device, print a copy for your records, or share it as needed.

Start filling out your MHRA Registration Form (RG2) online today to ensure your optical practice is compliant with regulatory standards.

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The Regulations provide that, unless exempt1, any medicinal product placed on the UK market must have a marketing authorisation (MA), traditional herbal registration (THR) or certificate of registration as a homoeopathic product granted by the European Commission or by the UK Licensing Authority.

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.

Medical Device Regulations and Classification in United Kingdom REGULATORY AUTHORITY: Medical devices in the UK are regulated by the Medicines and Healthcare Products Regulatory Agency (MHRA). CLASSIFICATION SYSTEM: TIMEFRAME: The registration process takes about 6 weeks.

UDI-DI information is not required in GB under domestic legislation as the EU MDR does not apply in GB. The submission of UDI-DI information will become mandatory if the new GB regulations require it.

Application process All UK and Great Britain (England, Scotland and Wales) national applications should be submitted through the MHRA Submissions Portal. If you have any questions about the Submissions Portal, you should email submissions@mhra.gov.uk.

The UK Responsible Person acts on behalf of the outside-UK manufacturer to carry out specified tasks in relation to the manufacturer's obligations. This includes registering the manufacturer's devices with the MHRA before the devices can be placed on the Great Britain market.

What is the cost and time to register medical devices in the UK? The MHRA charges a fee of £240 for each registration. Companies can submit up to 100 device registrations under that £240 fee, if all are registered at the same time.

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© Copyright 1997-2025
airSlate Legal Forms, Inc.
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Form Packages
Adoption
Bankruptcy
Contractors
Divorce
Home Sales
Employment
Identity Theft
Incorporation
Landlord Tenant
Living Trust
Name Change
Personal Planning
Small Business
Wills & Estates
Packages A-Z
Form Categories
Affidavits
Bankruptcy
Bill of Sale
Corporate - LLC
Divorce
Employment
Identity Theft
Internet Technology
Landlord Tenant
Living Wills
Name Change
Power of Attorney
Real Estate
Small Estates
Wills
All Forms
Forms A-Z
Form Library
Customer Service
Terms of Service
Privacy Notice
Legal Hub
Content Takedown Policy
Bug Bounty Program
About Us
Help Portal
Legal Resources
Blog
Affiliates
Contact Us
Delete My Account
Site Map
Industries
Forms in Spanish
Localized Forms
State-specific Forms
Forms Kit
Legal Guides
Real Estate Handbook
All Guides
Prepared for You
Notarize
Incorporation services
Our Customers
For Consumers
For Small Business
For Attorneys
Our Sites
US Legal Forms
USLegal
FormsPass
pdfFiller
signNow
airSlate WorkFlow
DocHub
Instapage
Social Media
Call us now toll free:
+1 833 426 79 33
As seen in:
  • USA Today logo picture
  • CBC News logo picture
  • LA Times logo picture
  • The Washington Post logo picture
  • AP logo picture
  • Forbes logo picture
© Copyright 1997-2025
airSlate Legal Forms, Inc.
3720 Flowood Dr, Flowood, Mississippi 39232