MHRA guidance and publications on a possible no deal scenario
The 20th March update has been implemented in the following section of the webpage:
From 29 March 2019, any medical device or an IVD placed on the UK market must be registered with the MHRA.
The MHRA will only register manufacturers that have a registered place of business (see section on ‘Definition of ‘registered place of business’ for more information) in the UK. If the manufacturer is based outside the UK, the manufacturer must assign a UK Responsible Person that has a registered place of business in the UK. This UK Responsible Person will then assume the responsibilities of the manufacturer in terms of registering the device.
Before you register with MHRA, you must ensure that your device meets all relevant legal requirements set out above.
Once you are satisfied that your devices meet all the relevant requirements, you can register with MHRA. We will provide further guidance on how to register with us in due course.
Definition of ‘registered places of business’
If the manufacturer or its UK Responsible Person is a UK company then the “registered place of business” should be the same as its “registered office” under the Companies Act 2006. That would be the address held by the Registrar of Companies, which would have been included in the original application for company registration (and any change of address would have been notified to the Registrar).
In certain cases, the UK Responsible Person may not be a company. If this is the case, the person’s contact address, or any address where official documents can be sent, will need to be provided. Please note that this address will be made publicly available on the MHRA’s Public Access Registrations Database (PARD).
Registering your device after 29 March 2019
After 29 March 2019, all medical devices, active implantable medical devices, IVDs and custom-made devices will need to be registered with the MHRA prior to being placed on the UK market.
Given that this is an extension of existing registration requirements, there will be a grace period to allow time for compliance with the new registration process.
For the following devices, you will have four months to register with the MHRA. This means you must be registered before 29 July 2019:
- Class III medical devices
- Class IIb implantable medical devices
- Active implantable medical devices
- IVD List A
For the following devices, you will have eight months to register with the MHRA. This means you must be registered before 29 November 2019:
- Class IIb non-implantable medical devices
- Class IIa medical devices
- IVD List B
- Self-test IVDs
For the following devices, you will have 12 months to register with the MHRA. This means you must be registered before 29 March 2020:
- Class I medical devices
- General IVDs
- Class A IVDs (if complying with the EU IVDR 2017/746)
Registration for custom-made devices will be in line with the risk class of the device. Failure to register by these dates will mean that you will no longer be able to lawfully place your device on the UK market.
Registration information to be provided to the MHRA
To register any class of device with MHRA, you will need to use Global Medical Devices Nomenclature (GMDN) to describe your device. You do not need to be a member of the GMDN Agency to find and select the appropriate GMDN terms within our online registration system.
Initially, the MHRA will require all devices to be registered at the level of GMDN code. If you do not know which GMDN code applies to your device, you will need to select the relevant description term from our system. However, for Class III devices, you must also provide the following product information:
- medical device name
- catalogue or reference number
These are recognised common data elements in the IMDRF Primary Medical Device Identity information.
You can read more about the registration obligations in regulation 7A (for medical devices), regulation 21A (for active implantable medical devices) and regulation 33A (for IVDs) in the UK MDR 2002 (as amended by the UK MDR 2019).
If you’re a manufacturer based outside of the UK
Registration of a device with the MHRA must be undertaken by a designated UK Responsible Person established in the UK and with a UK registered address who will take responsibility for the device in the UK.
You can read more about the UK Responsible Person above, in the section regarding ‘Role of those manufacturing and supply devices’. You can also read about this Person’s obligations in regulation 77 (for medical devices)and regulation 146 (for IVDs) of the UK MDR 2002 (as amended by the UK MDR 2019).
How to register your medical devices in a no deal scenario
The Agency is making preparations to ensure that, in the event that the UK leaves the EU on 29 March 2019 without a deal, we are able to process the anticipated volume of devices which will require registration with the MHRA.
For this reason, we intend to process registrations in phases in line with the regulatory deadlines set for each device class. We will take into account how many devices you intend to register.
In a no deal scenario, the deadline for all high-risk devices listed below to be registered with the MHRA is 29 July 2019:
- Class IIb implantable devices
- Class III medical devices
- Active implantable medical devices
- Annex II List A IVDs
- Procedure packs that include any of the above devices
For all other medical devices and IVDs, we ask that you wait until we provide further updates on when to register with us.
Registration for custom-made devices will be in line with the risk class of the device.
If you intend to register high risk devices that fall within the above categories, please email email@example.com using the following subject line heading:
“[Your organisation name] - Intention to register high risk devices”.
The body of the email should contain the following information:
- Your contact details (including your organisation’s legal address and an email address you can be contacted on)
- Your organisation name
- Whether you are a UK Responsible Person acting on behalf of a manufacturer based outside of the UK (further information on the role of a UK Responsible Person can be found in our guidance published on 26 February 2019)
- An indication of how many devices and products you intend to register with us (for each organisation if you are the authorised representative)
If you are currently a UK based authorised representative, please provide details of all organisations that you represent.
You will receive an auto-response confirming receipt of your email, and we will then contact you in due course with further instructions on the registration process.
To prepare for registering your devices with us, we advise that you compile lists of the devices you intend to register, along with the GMDN code/term. We will also require copies of the associated CE certificates.
For Class III devices you will also need to compile the corresponding product information (device name, model, catalogue number, UDI (if applicable).
You will be charged a statutory fee of £100 per registration application. Depending on the number of devices you have, you may be able to register all of these in one application.
A fee of £100 also applies for adding new and/or subsequent changes to medical device(s) and/or in vitro diagnostic device(s) registrations.
Manufacturers who are already registered with the MHRA
If you are already registered with the MHRA, you will need to confirm the accuracy of the information registered with the MHRA by the relevant dates set out above. There will be no charge for this, unless you need to make any changes.
You must notify us of changes to your registration details and a statutory fee of £100 is chargeable for a change of:
- your registered place of business
- company name
- company type e.g. if you become a limited company
- adding device(s) to your registration record
- status of an IVD, for example a change from ‘performance evaluation’ to ‘new’
Where the manufacturer is currently registered on our systems through an EU Authorised Representative, you must update the information to include a UK Responsible Person. The fee of £100 will apply if you need to update information to include the details of a UK Responsible Person.
The fee is not chargeable for:
- change of email address or telephone numbers
- adding or removing product information for your registered devices
- removing devices from your registration record
Requirement to regularly update the information
You must renew your registration one year after your registration application or confirmation was made and every two years after this date. For each renewal, you will be charged the £100 statutory fee (see below for further information).
Failure to renew your registration will result in the removal of your records from our database, after which you will need to complete a new registration application or you will no longer be able to place your device on the UK market.
Register of manufacturers
Once registered, your company name and address are added to the Public Access Database for Medical Device Registration. Records are listed by manufacturer name, address, MHRA reference number and list the device types registered with us.
Registering your devices with MHRA does not mean that we give you any form of accreditation, certification or approval for the device and you should not claim this in any marketing materials, on the packaging or in the instructions for use.
Future changes to registering your device from May 2020
Changes to registration requirements will come into force on 26 May 2020 for medical devices and on 26 May 2022 for IVDs. The additional registration requirements can be found in regulations 91 to 95 (for medical devices) and regulations 157 to 160 (for IVDs) of the UK MDR 2002 (as amended by the UK MDR 2019).
Post-market surveillance and vigilance
MHRA operates the system for reporting and recording details of suspected adverse incidents relating to a medical device or IVD which occur in the UK. A key responsibility of the MHRA is to investigate device-related adverse incidents or monitor investigations carried out by the manufacturer and take appropriate action to prevent or reduce the likelihood of recurrence as part of its market surveillance role. If a non-compliances are found during an investigation of a manufacturer, the manufacturer has a statutory obligation to resolve these non-compliances.
Once a medical device has been placed on the UK market in compliance with the applicable legislation, the manufacturer must continually monitor the safety and performance of their device. The manufacturer must submit vigilance reports to the MHRA when certain incidents occur in the UK involving their device and take appropriate safety action when required. The manufacturer must ensure the device meets appropriate standards of safety and performance for as long as it is in use.
From 29 March 2019, where a manufacturer is based outside of the UK, it must have in place a UK Responsible Person. This UK Responsible Person will be required to meet certain reporting requirements, as set out in regulation 7A (for medical devices), regulation 21A (for active implantable medical devices) and regulation 33A (for IVDs) in the UK MDR 2002 (as amended by the UK MDR 2019).
Please see our guidance page for further information on manufacturer reporting requirements.
Future changes to post-market surveillance requirements from May 2020
From 26 May 2020 (for medical devices) and May 2022 (for IVDs) new requirements relating to a manufacturer’s post market surveillance system will be in place that will require manufacturers to adhere to increased requirements around post-market surveillance and vigilance. This will include maintaining a post-market surveillance plan and issuing periodic safety update reports (PSURs). Further information for post-market surveillance requirements can be found under regulations 121 to 124 (for medical devices)and regulations 186 to 189 (for IVDs) of the UK MDR 2002 (as amended by the UK MDR 2019).
Additionally, the new vigilance requirements define specific reporting requirements which include but are not limited to defined time frames for notifying the MHRA of incidents and the preparation of manufacturer reports after the occurrence of incidents. Full information on vigilance can be found under regulations 125 to 129 (for medical devices) and regulations 190 to 194 (for IVDs) of the UK MDR 2002 (as amended by the UK MDR 2019).
Please direct any queries to firstname.lastname@example.org.