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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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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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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
DMCA Policy
About Us
Blog
Affiliates
Contact Us
Privacy Notice
Delete My Account
Site Map
All Forms
Search all Forms
Industries
Forms in Spanish
Localized Forms
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 workflows
DocHub
Instapage
Social Media
Call us now toll free:
1-877-389-0141
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