The long awaited In Vitro Medical Devices Regulations 2000 (IVD Regulations) finally came in to force on 7 June 2000 to directly implement Directive 98/79/EC on In Vitro Medical Devices (IVD Directive). The enforcement of the IVD Directive will introduce common regulatory requirements for in vitro diagnostic products across Europe, bringing them in line with all other medical devices.

IVDs

In vitro medical devices (IVDs) cover any medical device, reagent, reagent product, kit, instrument, apparatus or substance which is intended to be used for the in vitro examination of substances derived from the human body, such as blood grouping reagents, pregnancy testing and hepatitis B test kits. All other medical devices are covered by existing regimes for active implantable medical devices and all other medical devices.

Transitional Provisions

The IVD Regulations include a transitional period until 7 December 2003, after which date manufacturers must comply with the legislation. IVDs which 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.

Until the IVD Regulations become mandatory on 7 December 2003 there are no other statutory controls dealing specifically with IVDs in the UK. The Medical Devices Agency (MDA) operates a voluntary evaluation program for certain IVDs to provide performance and safety evaluation to potential purchasers.

General legal requirements will apply to IVD manufacturers as they do to all medical device manufacturers; these include, for example, the Health and Safety at Work Act 1974 (general duty to ensure that any article for use at work is safe and without risk to health, has been appropriately tested and examined and adequate information about use provided) and the General Product Safety Regulations 1994 (impose safety requirements on any consumer product for which there are no specific provisions in European law governing all aspects of safety).

Marketing Authorisation

Before an IVD can be placed on the market in the EU the manufacturer must comply with a number of requirements of the IVD Directive. In the UK the IVD Regulations require direct compliance with the IVD Directive, application for marketing approval is made to the UK Competent Authority, the MDA. The MDA is responsible for ensuring that all medical devices comply with IVD regulatory requirements before they are released on to the market and for the post-marketing observation of such devices.

Classification of IVDs

The pre-marketing requirements for IVDs are dependent on their intended use and the associated hazards. Under the IVD Directive IVDs are divided into four groups, the level of pre-marketing examination required is dependant on the category the devices falls in:

• general IVDs
• IVDs for self testing i.e. test kits used in a home environment excluding those included in Annex II of the IVD Directive
• IVDs in Annex II List B of the IVD Directive: e.g. test kits for rubella, chlamydia, CMV, PSA, blood glucose or the major tissue typing groups
• IVDs in Annex II List A of the IVD Directive: e.g. test kits for HIV, hepatitis B, C, or D, HTLV and the major blood groups.

Declaration of Conformity

Before an IVD can be placed on the market the manufacturer is required to ensure the IVD complies with the 'declaration of conformity' of the IVD Directive. Declaring conformity with the IVD Directive provides a consistent method of assessing the safety and efficacy of the IVD.

As for other types of medical device, the level of control is proportionate to the risks associated with the relative dangers to public health and/or patient treatment should an IVD fail to perform as expected. "Notified Bodies" (e.g. BSI Product Certification) are used to examine IVDs which carry higher risks associated with their usage to ensure compliance with the IVD Directive. This examination, as for all other types of medical device, forms an integral part in declaring conformity to the IVD Directive.

Essential Requirements and CE Marking

There are a set of essential requirements in the IVD Directive which specify how an IVD must be designed, manufactured, labelled and packaged to ensure safe and effective use. In addition to this requirement, all IVDs must be CE marked and conform. By declaring conformity the manufacturer indicates compliance with these Essential Requirements. This must be done before they can be released onto the market.

Risk and Notified Bodies

Whilst the manufacturer declares conformity with the provisions of the IVD Directive there is no requirement for involvement of a Notified Body. Before the manufacturer of higher risk IVDs (e.g. Annex II of more complex self test IVDs) can draw up the declaration of conformity as for general IVDs it must first lodge an application with a Notified Body for the examination and assessment of the design of the device and in some instances the systems of manufacture. This can involve an audit of the full quality assurance system and review the product dossier or even an EC type-examination, plus audit of the production quality assurance system. For products in list A of Annex II (and where appropriate list B) common technical specifications (CTS) will be developed to establish the performance characteristics of the device. CTSs may then be used to demonstrate conformity with the IVD Directive.

Conclusion

The implementation of the IVD Directive should enhance the safety of products placed on the market and harmonise requirements in Europe for manufacturers of IVDs as similar procedures will apply for all medical devices in all Member States.

This article first appeared in IPeye, the intellectual property newsletter published by Eversheds Solicitors. For more information about, or to receive copies of IPeye, please contact Janet Knowles on 0161 837 6107 or at janetknowles@eversheds.com

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