This directive, along with two associated directives, the Medical Devices Directive and the Active Implantable Medical Devices Directive, cover all medical equipment for use in Great Britain. The directives came fully into force in June 2000 and are enforced in the UK by the Medicines and Healthcare Products Regulatory Agency (MHRA). Different regulations apply for devices to be placed on the market or put into use in Europe and Northern Ireland.
The IVD directive includes equipment intended by the manufacturer to be used to diagnose, prevent, monitor, treat, alleviate, compensate for and/or control a disease, injury, handicap, physiological process or conception. It covers equipment used in laboratories, not in the patient environment and also excludes any products which come under the scope of one of the other two medical directives.
The In Vitro Diagnostic Medical Devices (IVD) Directive (98/79/EC) was enacted to provide for a harmonised regulatory environment for all in vitro diagnostic medical (IVD) devices sold within the European Economic Area. All products which fall within the scope of the Directive must meet certain essential safety and administrative requirements and are to be UKCA marked to show that they comply. Such products may then be freely sold throughout Great Britain.
The IVD Directive defines an IVD device 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.“
This definition needs to be read in conjunction with the definition of a medical device in the Medical Devices Directive.
Excluded from the Directive are invasive sampling devices and apparatus that process blood for re-introduction into the body - these are Medical Devices. Also excluded are general-purpose laboratory apparatus. Devices for performance evaluation of IVD devices are not IVD devices but manufacturers must prepare documentation to be available for inspection by the Competent Authority.
Like the Medical Devices Directive (MDD), the IVDD includes provisions for all relevant hazards, including mechanical and electrical safety and provisions for electromagnetic compatibility. Devices which fall within the scope of the IVDD are, as with the MDD and the AIMDD, generally excluded from the scope of the other Directives. However, equipment which may have an application which is not exclusively medical will usually have to comply with the other Directives.
Examples of IVD Devices
- Laboratory centrifuge, blood composition analyzer.
- Personal use OTC devices: blood sugar monitors, pregnancy testers.
- Specimen receptacles and other accessories to an IVD device are also considered as IVD devices.
As with other Directives the IVD Directive applies only to products placed on the market and not, for example, devices manufactured for use within a single legal entity (eg. NHS Trust).
The directive applies different administrative requirements to devices depending on the risk which they present to the user. There are four classifications:
- General devices
- Self test devices not listed in Annex II of the IVDD
- Devices listed in Annex II List A
- Devices listed in Annex II List B
Annex II Listed devices:
A: Reagents and reagent products, including related calibrators and control materials for:
- determining the blood groups: ABO system, rhesus (C, c, D, E, e) anti-Kell,
- the detection, confirmation and quantification in human specimens of markers of HIV infection (HIV 1 and 2), HTLV I and II, and hepatitis B, C and D.
B: Reagents and reagent products, including related calibrators and control materials for:
- determining the blood groups: anti-Duffy and anti-Kidd,
- determining irregular anti-erythrocytic antibodies,
- the detection and quantification in human samples of the congenital infections: rubella, toxoplasmosis,
- diagnosing the hereditary disease: phenylketonuria,
- determining the human infections: cytomegalovirus and chlamydia,
- determining the HLA tissue groups: DR, A, B,
- determining the tumoral marker: PSA,
- evaluating the risk of trisomy 21 (specifically designed and including software), and devices for:
- measurement of blood sugar for self-diagnosis, including its related calibrators and control materials.
The ‘manufacturer’ or authorised representative, as the legal entity in Europe, must ensure that the device meets the essential requirements specified in Annex I of the Directive and follow the appropriate conformity assessment procedure.
Manufacturers (or their agents) must typically:
- comply with the general safety and performance requirements of Annex I of the Directive
- demonstrate design verification
- carry out a risk assessment
- demonstrate clinical evidence of the effectiveness of the device
- implement a procedure for post-market surveillance
- complete a Declaration of Conformity
- maintain a file of technical information about the product
- put the CE mark on the product (or its packaging)
- for General Devices, register with the Medicines and Healthcare products regulatory Agency (MHRA), the Competent Authority in the UK or, for all other devices apply to a Notified Body.
Annex 1 of the Directive lays down a series of essential requirements for the design of medical devices. These include (among others):
- a general requirement for safe design
- the minimisation of risks from contamination
- compatibility with materials with which they are likely to come into contact
- the minimisation of hazards of infection and microbial contamination
- provision of sufficient accuracy
- protection against radiation
- adequate product marking
- adequate user instructions
The details of these essential requirements are laid out in a series of standards which have been (or are being) developed to meet the requirements of the Directive.
Conformity assessment methods are similar to those of the MDD being largely quality system based.
General devices are self-certified, the manufacturer must compile a technical file which is available for inspection upon request by the Competent Authority.
Self-test devices not listed in Annex II: either one of the methods for Annex II devices is followed or the Notified Body performs limited testing/inspections appropriate to the device.
Annex II List A devices require either a full quality system, or alternatively, an EC Type examination of the device together with a production quality system and final product/batch verification.
Annex II List B devices require a full quality system or alternatively, an EC type examination of the device together with final product examination (EC Verification).
In all cases except for General Devices, the Notified Body, where appropriate, assesses the quality system, inspects the Product design Dossier, and performs testing and design examinations.
One of the provisions which distinguishes the Medical Device Directives from the other New Approach Directives is that they establish standing committees to consider the development and application of standards produced in support of the essential requirements, and to consider (in effect) 'matters arising' regarding the safety of devices within the scope of the Directives.
As part of this process of consideration, a formal post-market surveillance, or vigilance plan and reporting procedure is required by the Regulation, through which manufacturers, health professionals and others must report certain problems which arise in the use of medical devices and in clinical trials. This vigilance system is administered by the competent authority in each of the member states, and requires each manufacturer to have a procedure in place for post market surveillance and reporting of adverse incidents.
The Directive came fully into force in December 2003, and all in-vitrio diagnostic medical devices manufactured and placed on the market after that date must comply.
The enforcement authority (“Competent Authority”) in the UK is the Medicines and Healthcare Products Regulatory Agency (MHRA).
The MHRA also have a very useful website including lots of helpful publications to download.