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Medicines, medical devices and blood regulation and
safety – guidance
Register as a manufacturer to sell
medical devices
From: Medicines and Healthcare products Regulatory Agency
First published: 18 December 2014
Last updated: 23 February 2016, see all updates
Part of: Medical devices regulation and safety, Medicines, medical
devices and blood regulation and safety and Patient safety
Register a manufacturer or authorised representative (agent) for a manufacturer, to sell
medical devices, including in vitro diagnostic (IVD) medical devices.
Contents Overview
Overview
If you place certain medical devices on the EU market you or your
When you must authorised representative (agent) must be registered with the competent
register
authority (national health regulator) in the EU state where you have an
Eligible devices and office or place of business. In the UK, Medicines and Healthcare Products
their codes Agency (MHRA) is the competent authority for the registration of medical
CE marking devices. MHRA will only register manufacturers or authorised
Apply to register with representatives that have a place of business in the UK.
the Device Online
Registration System Before you register, you must first complete a conformity assessment , so
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Register as a manufacturer to sell medical devices - Detailed guidance - [Link]
(DORS) you can put the CE marking on your products.
Making changes to
your DORS
registration
When you must register
Contact
You must inform a competent authority (in the UK this is the MHRA) when
you first place your device on the market. You must register if you or your
company sells, leases, lends or gifts:
class I devices you have manufactured
class I devices you have refurbished or re-labelled with your own name
any system or procedure pack containing at least one medical device
custom-made devices
‘in vitro diagnostic medical device’ (IVD) you have manufactured
in vitro diagnostic medical devices (IVDs) undergoing performance
evaluation
Note: We do not register devices classified as class IIa, IIb, III or active
implantable devices. For these, you need to follow the appropriate
conformity assessment route, which includes being assessed by a notified
body.
Manufacturers without a place of business in the EU need to appoint an
authorised representative in the EU. Only one authorised representative
can be designated within the EU for each product type.
Eligible devices and their codes
Class I devices
Examples of class I devices include:
dental and surgical instruments
stethoscopes and ophthalmoscopes
bandages and splints
spectacle lenses and frames
treatment chairs and hospital beds
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Examples of products that are not medical devices include:
toiletries
tattooing instruments
protective equipment
swabs, wipes and disinfectants
The European Commission has a guidance document Definitions of
“medical devices”, “accessory” and “manufacturer” (MEDDEV 2.1/1) .
Custom-made devices, systems and procedure packs
You will need to register if your company:
places devices bearing the CE marking on the market, under your own
name in a system or a procedure pack within their intended purposes
and within the limits of uses specified by their original manufacturers
sterilises, for the purpose of placing on the market under your own
name, systems or procedure packs or other CE marked medical
devices designed by the manufacturer to be sterilised before use
There is more information about custom-made devices and examples of
the information we need on your statement on this page.
To register your medical device with the MHRA, you can use either of the
following lists of codes:
MHRA generic device description codes
the Global Medical Devices Nomenclature System
In vitro diagnostic medical devices
Examples of in vitro diagnostic (IVD) medical devices include cultures,
reagents, antigens, serums, plasmas etc and testing kits and equipment
for these.
You will need to specify the correct codes for your IVD medical devices.
You can use either of the following lists of codes to register your IVD
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device with the MHRA:
the Global Medical Devices Nomenclature System
the European Diagnostic Manufacturers Association (EDMA)
CE marking
The CE marking is a declaration of conformity with the EU’s Medical
Devices Directive (MDD).
For class I devices (those with the lowest risk level) you must ensure that
your product complies with all the relevant essential requirements of the
MDD and draw up a written statement to this effect (self-declaration).
If you manufacture sterile products or devices with a measuring function
you must apply to a notified body for certification.
Once you are satisfied that your products meet all the relevant essential
requirements, you can register with MHRA (or other EU authority), then
you can put the CE mark on the product(s) and place them on the market.
Find out more about the conformity assessment for medical devices in
section 2.5 of Guidance MEDDEVs on the European Commissions
website.
Apply to register with the Device Online Registration
System (DORS)
Using DORS you can register medical devices and IVD devices and
manage your account details. First you need to create an account on
DORS and wait for the email from us confirming that it is active before you
can start registering your products.
Start the process on the device online registration system
(DORS) and we will email you when it’s activated.
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You must pay £70 via DORS per registration.
There is more information about DORS here .
If you are an authorised representative (AR) of a non-EU manufacturer you
must provide written evidence that you are acting with the consent of the
manufacturer. We need an official letter, on headed paper, from the
manufacturer stating your company’s name and address – this is the
designation letter.
If you are taking over the role from an existing authorised representative
we need the designation letter and a copy of the letter cancelling the
service with the previous representative.
The European Commission has guidance for authorised
representatives .
Making changes to your DORS registration
You must inform MHRA, by updating your DORS record, if you want to
change:
address
addition of device types
manufacturer name
authorised representative
status of an IVD, for example a change from ‘performance evaluation’ to
‘new’
You must pay £70 for each change request but you can change more than
one detail within each registration request. We have to check these
changes so they won’t appear immediately in your DORS record.
Changes you can make for free by updating your DORS record include:
removing a device from your records
changing a contact person
changing a telephone number and/or email address.
There is no need to tell us if you decide to sell extra products that fall
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under the same generic product code you have already registered with us.
Register of manufacturers
Once registered, your company will be added to the Public Access
Database for Medical Device Registration . Records are listed by
manufacturer and device and include contact details. Manufacturers of in
vitro diagnostic medical devices will not be published on this database, as
the IVD Directive confidentiality clause still applies.
Registering your devices with MHRA does not mean that we
give you any form of accreditation, certification or approval for
the device. It is just a notification of your activities.
Contact
If you are already registered with us, please contact us under the following
alphabetical splits for your company name or the surname under which
the registration is held, quoting your reference number:
A – D Jasu Patel on 020 3080 7195
E – M Barbara Clarke on 020 3080 7318
N – Z Angela Bartley on 020 3080 7149
Email: mb-mda-era@[Link]
Published: From:
18 December 2014 Medicines and Healthcare products Regulatory Agency
Updated: Part of:
23 February 2016 Patient safety
+ full page history
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