Registration
How is the safety of medical devices controlled within the UK?
Most medical devices now placed on the UK market have to comply with device specific legislation. This results from the UK having transposed into its national laws a series of European medical device Directives. These have been transposed as safety regulations under the Consumer Protection Act.
Who is responsible for implementing the Medical Devices Directive?
The MHRA has been designated as the UK's Competent Authority for the Medical Devices Directives. This means it is responsible for a range of functions allocated to national authorities by the Directives such as ensuring that the Directives provisions are followed by manufacturers and others as appropriate, the designation and control of Notified Bodies, assessing clinical trial notifications from manufacturers and maintaining a register of manufacturers of certain types of devices.
For List of EC Competent Authorities contact the Commission - Tel: 00 32 2295 9154/9339 or Fax: 00 33 32 2296 7013 or go to their website.
What are the Medical Devices Directives?
There are three European Directives concerning medical devices. The first, the Active Implantable Medical Devices Directive (90/385/EEC) came into force on 1 January 1995. An example of an active implant is a pacemaker. The second, the Medical Devices Directive (93/42/EEC) came into force in June 1998 and covers the large majority of medical devices. This Directive was amended in Directives 2000/70 and 2001/104 to extend its scope to those devices incorporating stable derivatives of human blood or human plasma and since then there have been other additions in relation to devices containing animal tissue, breast implants and joint replacements. The third, is the In Vitro Diagnostic Medical Devices Directive (98/79/EC) which came into force in December 2003. This Directive covers any reagent, reagent product, calibrator, control material kit, instrument, apparatus, equipment or system intended for use for the in vitro examination of specimens, including blood and tissue donations, derived from the human body.
What is the purpose of the Directives?
The Directives are principally trade measures designed to remove technical barriers to trade within Europe and create a single market for medical devices within the EU. However, by harmonising the regulations governing medical device manufacturers, they also aim to improve the level of protection of patients, users and third parties and ensure that devices perform as intended.
How do the Directives achieve their aims?
Each Directive contains a wide-ranging and comprehensive list of Essential Requirements covering items such as electrical safety, chemical and mechanical safety, biocompatibility, and labelling requirements. The device manufacturer is obliged to ensure that his device meets each relevant Essential Requirement and to demonstrate that this is so by completing the relevant conformity assessment procedures specified in the Directive. These conformity assessment procedures become more demanding as the perceived level of risk associated with the device increases. For all but low risk devices, there must be the involvement of independent third party certification bodies called Notified Bodies. Conformity is demonstrated by the manufacturer signing a declaration of conformity and affixing of the CE-mark to the device before it is placed on the market.
› For further information about the CE mark see Bulletin 2.
(201Kb)
› For further information about conformity assessment procedures see Bulletin 4 (82Kb).
› For further information about Notified Bodies see Guidance Note 6. (181Kb)
What is the CE Mark?
The CE mark is the public representation of the manufacturer's claim that his device satisfies the relevant Essential Requirements in the Directives, is fit for its intended purpose and, where required, has been independently assessed by a Notified Body.
Medical devices bearing the CE mark can be freely marketed anywhere in the EU without further control.
The CE mark should be at least 5mm in size, appear on the packaging, instruction leaflets and the device itself (where practicable), and, where a Notified Body has been involved in the conformity assessment process, the identification number assigned to it by the Commission.
› For further information on the CE mark see Bulletin 2. (201Kb)
Must all medical devices bear the CE mark?
Generally all devices, covered by the scope of the relevant Directive, should bear the CE mark when placed on the market. However there are some specific exemptions. These are:
- Custom-made devices
- Devices undergoing a clinical investigation
- Devices for performance evaluation
› For further information about Custom Made devices see Guidance Note 9 (283Kb).
› For further information about clinical investigations see Guidance Note 1 (741Kb).
Does a manufacturer need to have his device licensed by a national authority before being sold?
No. The Directives place the responsibility for meeting the rules set out in the Directives firmly on the manufacturer, working with the Notified Body as required.
Notified Bodies
What are Notified Bodies?
A Notified Body is an independent certification body designated by a Competent Authority to conduct conformity assessment procedures specified in the various Directives. A manufacturer may choose any Notified Body provided it has been designated to perform the particular conformity assessment procedure it wishes to use. A complete list of Notified Bodies is published in the EU's Official journal and is available on the EU Commission's website. UK Notified Bodies are listed on the MHRA website.
Medical Devices Directive
What is the Medical Devices Directive?
The Medical Devices Directive harmonises the regulatory requirements for medical devices within the EU. It came into force in June 1998 and covers most medical devices.
What is a Medical Device?
The Medical Devices directive defines a medical devices as:
'any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application intended by the manufacturer to be used for human beings for the purpose of:
- diagnosis, prevention, monitoring, treatment or alleviation of disease,
- diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
- investigation, replacement or modification of the anatomy or of a physiological process,
- control of conception,
and which does not achieve its principle intended action in or on the human body by pharmacological, immunological or metabolic means, but may be assisted in its function by such means.'
How are the levels of risk of each type of medical device determined?
The Medical Devices Directive includes a classification system whereby the level of regulatory control applied to devices is proportionate to the degree of risk associated with the device. There are four different classes of device. Class I for low risk, Class IIa and IIb for moderate risk and Class III for high risk. The class of the device will affect the choice of conformity assessment procedures the manufacturer may choose to demonstrate compliance with the essential requirements. Thus:
- For low risk devices (ie Class I) the manufacturer may complete the conformity assessment process itself (self assessment) entirely on his own responsibility.
- For moderate and high risk devices (ie Class IIa, IIb and III) the manufacturer must employ an independent certification body called a Notified Body to carry out the conformity assessment procedure.
› For further information on Notified Bodies see Guidance Note 6. (181Kb)
› For further information on Conformity assessment procedures see Bulletin 4 (148Kb).
› For further information about the Medical Devices Directive see Bulletin 8. (82Kb)
How do I know which risk category my device falls within?
The Medical Devices Directive gives rules for the classification of devices into one of four different classes based on the perceived level of risk associated with the device. The risk classification is important in that it determines which conformity assessment route the manufacturer may use to demonstrate compliance with the Directive's requirements.
In addition to the Directive itself the following provide useful information on device classification:
- MEDDEV 2.4/1 (external link) available at the European Commission website
- Bulletin 10 (70Kb) The Classification Rules produced by MHRA
Is my product a medical device?
Some devices fall into the borderline between what is and is not a medical device. There are three main points of reference:
- The Medical Device Directive (external link)
- MEDDEV 2.13 (external link) and Bulletin 17 (131Kb). Both provide useful information about the borderline between a medicine and a medical device.
- MEDDEV 2.11 (external link) expands on the definition of a medical device.
Finally, you may wish to write to the MHRA, giving details of your device including its mode of action and intended purpose. To assist manufacturers we are willing to give any help and advice we can. However, any views given by us on the interpretation of those Regulations represent our best judgement at the time based on the information available. It is not meant to be a definitive statement of law. Accordingly, we would always advise you to seek advice from your professional advisors.
Is my software a medical device?
It may be depending upon its purpose. The European Commission Guidelines Document MEDDEV 2.1/1 (external link) draws a distinction between software provided for a diagnostic or therapeutic tool and software for handling general patient-related data. A medical purpose may be determined only in the first case.
How do I CE mark my medical device?
Manufacturers of Class I devices can self-certify conformity to the Essential Requirements of the Medical Devices Directive. However a Notified Body must be involved when CE marking a Class I device which is sterile or has a measuring function. In these cases the Notified Body will only verify the sterility or metrology aspects of the device. A Notified Body must also be involved in the conformity assessment of all Class IIa, IIB and III devices.
› For further information about Conformity Assessment procedures see Bulletin 4 (148Kb).
In Vitro Diagnostic Medical Devices Directive
What is an IVD?
The In Vitro Diagnostic Medical Devices Directive (98/79/EC) defines an IVD as:
"any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information:
- concerning a physiological or pathological state, or
- concerning a congenital abnormality, or
- to determine the safety and compatibility with potential recipients, or
- to monitor therapeutic measures
and includes a specimen receptacle but not a product for general laboratory unless that product , in view of its characteristics, is specifically included by the manufacturer to be used for In Vitro diagnostic examinations".
How are IVDs classified?
The IVD Directive takes a similar approach to the Medical Devices Directive (MDD) in that it groups devices so that the level of regulatory control applied will be proportionate to the degree of perceived risk based on who the device user may be or the effect if it fails to perform as intended. This is achieved by grouping IVDs into one of four categories:
- general;
- self-testing;
- Annex II List B - which, amongst others, includes self-test kits for rubella, toxoplasmosis and phenylketonuria test kits, as well as self-test devices for blood glucose;
- Annex II List A - which includes test kits for HIV, HTLV and Hepatitis and some blood grouping products including those used to test donated blood.
IVDs for self-testing and those included in Annex II List A and B need the intervention of a Notified Body in the Conformity Assessment procedure before the device may be CE-marked and placed on the market.
› For further information about IVDs see Bulletin 12 (122Kb) Sale and Supply of In Vitro Diagnostic Medical Devices (IVDs).
Active implantable Medical Devices
The AIMD Directive 90/385/EEC defines an active implantable medical device as:
'any active medical device which is intended to be totally or partially introduced, surgically or medically, into the human body or by medical intervention into a natural orifice, and which is intended to remain after the procedure'.
The conformity assessment procedure for IVDs is similar to that for class III medical devices. There is no requirement to register IVDs.
Registration
Who should register?
The medical devices Regulations require manufacturers of generally low risk devices to register in the country in which they have their registered place of business. 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 an Authorised Representative based within the European Community to register on your behalf. UK-based Authorised Representatives registering with the MHRA are required to enclose a copy of your letter of designation together with a completed RG2 form (275Kb).
After I have registered, do I need to report changes?
There is no need to inform the MHRA of additional products being manufactured if you have already registered with a generic code within which the new products fall. However, any products falling outside of the generic codes for which the company is registered, any change of address etc should be notified to the MHRA on an RG2 form (275Kb).
How do I register an IVD?
Manufacturers of IVDs have to register with the regulatory authority of the Member State(s) in which he, or if outside the EEA, his representative in the Community has a place of business.
The following details will be required:
- Name and address of registered place of business of manufacturer or authorised representative,
- Information relating to reagents, reagents products and calibration and control materials and any significant changes and discontinuation of placing on the market,
- Appropriate indications relating to kits, instruments, apparatus, equipment or systems,
- For Annex II and self-test products all data allowing for the identification, the analytical and where appropriated diagnostic parameters, the outcome of performance evaluations, certificates and any changes and discontinuation of placing on the market,
- Notification of "new" devices (as defined in Article 10.4 of the Directive).
MHRA's Registration Pack and RG3 application form (256Kb) are designed to guide you through how to present the above information. Until the European Data Base is set up manufacturers of IVDs are required to register in every member state where they are placing products on the market.
When should I register my IVD?
The UK Regulations implementing the Directive came into force on the 7 June 2000 with a transition period of 3.5 years until December 2003. IVDs that conform to existing national legislation and are already in the distribution chain at the end of the transitional period can continue to be supplied to the end user for a further two years i.e. until 7 December 2005. At present manufacturers should be adhering to SI 1992 No 462 (HIV Testing Kits and Services Regulations). For example, SI 1992 No 460 prohibits the sale of HIV testing kits or HIV testing services to members of the public, and specifies warnings that should be included in the device labelling for these products.
Do I need to register a 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 manufacturers 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 IVD's 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 by the end of the second transition period - 7 December 2005).
Do I need to register a sterile service department?
Simple sterilisation of devices that do not change the ownership of the devices and without incorporation into new procedure pads is not regarded as coming within the scope of the 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. In all other circumstances however it is likely that you will need to complete an RG2 (275Kb) to register.
Do I have to register as an Optometrist?
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 opthtalmic products is available.
How much does registration cost?
Registration costs £70 per RG2 (275Kb) or RG3 (256Kb) form; please note multiple devices can be registered on one form. There is more information available in the following publication - Optical Flyer (168Kb).
What advice is available to help me register with the MHRA?
