Registration of medical devices: Frequently asked questions

Raised handWho should register
Commercial testing service
Registration of a sterile service department (SSD)
Optometrists
Reporting changes after registration
Changes of phone numbers, contact person or removal of devices
Registration costs
Fees
Contacting us by phone
Renewal
Device codes for parts 7, 8 and 9 of the RG2 form
Additional documentation regarding the devices placed on the market
Placing devices on the market once registration forms are submitted
Appointment of authorised representative for EFTA members Iceland, Liechtenstein, Norway and Switzerland
MHRA logo on your packing and labelling of our products
Authorised representatives within the EU
Contact the MHRA

Who should register
Persons (under their own name and who have a registered place of business within the UK) responsible for placing on the market and putting into service devices classified as:

  • class I systems and procedure packs
  • custom-made
  • custom-made active implantable
  • in vitro diagnostic

Please note the Regulations define the manufacturer as the ‘person who is responsible for the design, manufacture, packaging and labelling of a device before it is placed on the market under his own name, regardless of whether these operations are carried out by that person himself or on his behalf by a third party’.

If you are a manufacturer of a device subject to registration, but do no have a registered place of business in a Member State, you will need to appoint a single authorised representative (AR) based within the European Union to register on your behalf.

It is the responsibility of the authorised representatives, who must have a registered place of business within the UK, to register with the MHRA using the appropriate registration forms, accompanied by the £70.00 statutory fee.

We do not register devices classified as class IIa, IIb, III or active implantable devices. However, for such devices you must follow the conformity assessment procedure appropriate for your device, which includes being assessed by a notified body in order to obtain the appropriate certifications and attach your CE mark.

Use form RG2 for registrations of class I systems and procedure packs, custom made devices, and custom made active implantable devices.

Use form RG3 for in vitro diagnostic devices.

Please refer to the section entitled ‘Supporting documentation required to complete the processing of notifications/registrations’ for the list of additional documentation required for completed AR registrations.

<Back to top>


Commercial testing service
Article 9.13 of the IVD Directive states that:
‘The provisions of this Article shall apply accordingly to any natural or legal person who manufactures devices covered by this Directive and, without placing them on the market, puts them into service and uses them in the context of his professional activity.’

For manufacturers of IVDs that provide a testing service for the public even though the kit may not be placed on the European market, the IVD still falls within the scope of the IVD Directive. Reagents and instruments used by testing service providers are required to be CE marked and requires the submission of a notification using an RG3 registration form.

<Back to top>


Registration of a sterile service department (SSD)
Simple sterilization of devices that do not change the ownership of the devices and without incorporation into new procedure packs is not regarded as coming within the scope of the Medical Devices Regulations. Similarly, if an SSD is part of a single legal entity (e.g. an NHS hospital trust) and supplies a service only within that legal entity, there is no placing on the market. In both these circumstances there is no requirement to register with the MHRA. In all other circumstances, however, it is likely that you will need to complete an RG2 form to register with the MHRA.

<Back to top>


Optometrists
Optometrists and glazing facilities assembling spectacles from CE-marked lenses and frames are likely to fall within the scope of the Medical Devices Directive under Article 12; more information on ophthalmic products is available.

<Back to top>


Reporting changes after registration
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 e.g. change from ‘performance evaluation’ to ‘new’ or ‘other'.

You must complete the appropriate registration form(s) RG2 and/or RG3 and submit it to the MHRA. Please refer to the section ‘Supporting documentation required to complete the processing of notifications/registrations’ for a list of additional documentation required to completed the processing of registrations submitted to us.

There is no need to inform the MHRA of additional products being placed on the UK market if you have already registered under a generic code within which the new products falls. However, any products falling outside of the generic codes registered i.e. an in vitro diagnostic and/or medical device(s) should be notified to the UK competent authority.

<Back to top>


Changes of phone numbers, contact person or removal of devices
You do not need to pay for these changes, but you should provide these types of changes in writing (email us on: mb-mda-era@mhra.gsi.gov.uk) 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

<Back to top>


Registration costs
Registration costs are £70 per RG2 or RG3 form; please note multiple devices can be registered on one form, by just copying additional page(s) when you run out of room.

<Back to top>

 


Fees

  • There is no fee per item placed on the form - 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.
  • There is no the fee payable for new and subsequent changes to the registered details

<Back to top>


Contacting us by phone
We do not accept changes to details by phone. All changes should be submitted in writing (email us on: mb-mda-era@mhra.gsi.gov.uk) by using the appropriate registration form RG2 or RG3 with the exception of changes covered under point 6.

<Back to top>


Renewal
You do not need to re-register every year. 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).

<Back to top>


Device codes for parts 7, 8 and 9 of the RG2 form
You will find the appropriate codes in the guidance section of the RG2 formPDF file (opens in new window) (73Kb).

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 and any pictures or diagrams of the device are provided to assist us in identifying the correct code.

<Back to top>


Additional documentation regarding the devices placed on the market
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.

<Back to top>


Placing devices on the market once registration forms are submitted 
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.

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.

<Back to top>


Appointment of authorised representative for EFTA members Iceland, Liechtenstein, Norway and Switzerland
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.

<Back to top>


MHRA logo on your packing and labelling of our products
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.

<Back to top>


Authorised representatives within the EU
The amendment Directive 2007/47/EC to the Medical Devices Directive 93/42/EEC stipulates that ‘where a manufacturer who places a device on the market under his own name does not have a registered place of business in a Member State, he shall designate a single authorised representative in the European Union’.

Recital 14 of Directive 2007/47/EC clarifies: ‘to introduce the obligation for such manufacturers to designate an authorised representative for a device. This designation should be effective at least for all devices of the same model.’

Further information is provided in the European Commission’s guidance document calledMEDDEV 2.5/10 January 2012 Guideline for authorised representatives’. It is not the intention that this provision restricts a manufacturer to a single authorised representative for the whole range of his products. The manufacturer may have more than one authorised representative as long as each device (type/model) is linked to only one authorised representative.

Therefore, under the amended legislation quoted above only one authorised representative can be designated within the EU for each product type.

<Back to top>


Contact the MHRA
If you still have queries regarding the registration process please contact us under the relevant alphabetical split for your company name, which is as follows:

A – D = Jasu Patel 020 3080 7195
E - M = Barbara Clarke 020 3080 7318
M - Z = Angela Bartley 020 3080 7149

or send your enquiry via email to: mb-mda-era@mhra.gsi.gov.uk

<Back to top>


Page last modified: 28 August 2013