1. Where do I find the device codes for parts 7, 8 and 9 of the RG2 form?
2. Is the fee per item placed on the form?
3. Is there a different fee for submitting a change for registration?
4. Do you have to pay for change of phone numbers, contact person or removal of devices?
5. Can we inform you of our change of registration by phone?
6. Do we have to renew our registration every year?
7. Should we provide additional documentation regarding the devices we are placing on the market ie technical files, certification of conformity certificates, devices catalogues etc?
8. May I place my devices on the market once I have submitted my registration forms accompanied with payment of the statutory fee to the UK competent authority?
9. Do the five EFTA members Iceland, Liechtenstein, Norway and Switzerland have to appoint an authorised representative if they wish to register with the UK Competent Authority?
10. May we place the MHRA logo on our packing and labelling of our products?
11. Further contact
1. Where do I find the device codes for parts 7, 8 and 9 of the RG2 form?
You will find the appropriate codes in the document:
MHRA list of generic code names for the RG2 form - Appendix A and Appendix B
(65Kb)
If you are still unable to assign a generic device code, you should provide details of the device and its intended use in sections 7a, 8a and/or 9a. It is also helpful if a copy of the Instructions For Use are provided to assist us in identifying the correct code.
2. Is the fee per item placed on the form?
No - it is payable per form submitted. You can also place multiple devices on the registration form RG2/3, by just copying additional page(s) when you run out of room.
3. Is there a different fee for submitting a change for registration?
No - the fee payable for new and subsequent changes to the registered details held is the same.
4. Do you have to pay for change of phone numbers, contact person or removal of devices?
No, but you should provide these types of changes in writing - providing your reference number, which appears at the top of your letter of registration, with your full name and address. All other changes should be submitted using the appropriate registration forms and the registration fee is applicable.
Such changes where payment is required include:
- change of address
- addition of device types
- change of manufacturer name
- change of authorised representative
- change in status of an IVD eg change from ‘performance evaluation’ to ‘new’ or ‘other'.
Any changes to the registered details held must be notified to the UK competent authority, otherwise you could be in breach of the legislation that applies if you fail to notify us.
5. Can we inform you of our change of registration by phone?
No - all changes should be submitted in writing by using the appropriate registration form RG2/3 with the exception of changes covered under point 4.
6. Do we have to renew our registration every year?
No - we only require an update of your registration when there has been a change to your registration details or if we require confirmation that you wish to remain registered (in which case we will write to you.
7. Should we provide additional documentation regarding the devices we are placing on the market ie technical files, certification of conformity certificates, devices catalogues etc?
We only require the RG2 and/or RG3 form, and the relevant letters in support of your notification if you are an authorised representative. If we have difficultly assigning the appropriate device code we may ask for further information.
8. May I place my devices on the market once I have submitted my registration forms accompanied with payment of the statutory fee to the UK competent authority?
Once you have submitted a valid notification under Regulations 19/44 and 53 of the Medical Devices Regulations 2002, you are free to place the medical and/or in vitro diagnostic medical device on the UK/EU market as long as all other requirements of the Regulations have been met.
Please also note that our letter acknowledging that the registration has been made is just our confirmation of registration and is not a legal requirement. You should also provide the registration number at the top of your registration letter when communicating with us, as this allows us to trace your information more readily.
9. Do the four EFTA members Iceland, Liechtenstein, Norway and Switzerland have to appoint an authorised representative if they wish to register with the UK Competent Authority?
No, as there is no requirement for companies within these countries to appoint an authorised representative they should submit a notification to their relevant competent authority within their own jurisdiction borders. Registration with the UK Competent Authority would not be appropriate.
In addition under a treaty signed with the EU, Turkey may also now accept notifications under the Medical Devices and In Vitro Diagnostic Medical Devices Directive and so no longer needs to designate an authorised representative to place these devices on the EU market.
10. May we place the MHRA logo on our packing and labelling of our products?
No - our logo is copyrighted and should not be used on any packaging, labelling or promotional material. You should also note in accepting a registration, the Competent Authority does not examine each individual notification and therefore cannot and does not necessarily endorse these determinations.
Neither does the letter confirming registration represent any form of accreditation or approval by the UK Competent Authority or a certification/certificate. Our letter is just confirmation that the registration process is at an end. You may freely place your allocated registration number on your packaging/labelling or provide a copy of your registration letter to your own customers as proof you are registered with the MHRA. However, this is purely your decision and should not be seen as a regulatory requirement of operating in the devices industry.
11. Further contact
If you still have any queries regarding the registration process please contact us under the relevant alphabetical split for your company name, which is as follows:
- A - J = 020 3080 7195
- L - Z = 020 3080 7325
Email: era@mhra.gsi.gov.uk
