Many companies have been slow to react to the Medical Devices Directive, despite it being implemented over 10 years ago. There is still insufficient industry understanding and acknowledgement of the Directive and its implications, with several people arguing that certain lights (especially examination lights) do not fit the “Medical Device” profile as outlined above. As such, these lights are not always manufactured to the European Union performance and safety standards as set out in the Directive.

As the UK’s leading medical lighting specialists, we have manufactured and tested our products to the guidelines set out in the Medical Device Directive for many years.

EU Directives have the task of harmonizing national legislation and regulations across all member states. Each country chooses how best to incorporate these Directives into their own legal system and then apply appropriate laws.

There are several Directives which are of particular relevance to the Medical Equipment industry. This article will focus on arguably the most important of these – the EC Medical Devices Directive 93/42/EEC.

Medical Devices Directive

This Directive was enacted to provide a harmonized regulatory environment for all Medical Devices sold within the EU. All products which fall within the scope of the Directive must meet certain essential safety and administrative requirements and are CE marked to show they comply.

The Directive defines a Medical Device 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, or 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 principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means."

Operating theatre, surgical, examination and reading lights which are also used for examinations all fall under this definition and are covered by the Directive.

This above definition of Medical Devices is expanded to cover 4 different risk classes of Device. All Brandon Medical products fall under Class I (Low Risk Devices). Further information on this classification can be found in Annex IX of the Directive.

Naturally, this leads us to another question – what is an operating theatre, surgical or examination light? Standard definitions are given in EN60601 as follows:

Operating Theatre Lamp System
Combination of lamps for local illumination of the body
Used for diagnosis or treatment
Minimum light output of 40,000 Lux
Light fail-safe owing to the combination of 2 or more lamps

Minor Surgical Light
For local illumination of the body
Used for diagnosis or treatment
Min 40,000 Lux
Not light fail-safe

Examination Light
For local illumination of the body
Used for diagnosis
Not light fail-safe

CE Marking

The CE Mark forms an integral part of the Medical Devices Directive.

While in theory article 100a of the Treaty of Rome should ensure that the legislation governing EC Markings is the same across the whole of the EU, the reality is that different member states have interpreted the Directive differently. This means that different CE marking standards need to be met in different countries.

Due to the Medical Devices Directive, every Medical Device sold within the EU has to carry this CE Mark, and the appropriate laws for each country have to be checked and adhered to.

A CE Certificate lists all the relevant international standards which a product has been manufactured to. In the case of lights, the most important standards to look for are EN60598 (Lamps) and EN60601 (Medical Electrical Equipment).

EN60589 – Lamps
This is the Basic Standard governing safety requirements applicable to lamps. Part 1 (General Safety Requirements) and Part 2-25 (Lamps for Rooms Used for Medical Purposes and for Hospitals) apply to Brandon Medical lights. In Part 2-25 a “Medical Room” is defined as hospitals, doctors’ surgeries, nursing homes or clinics etc. in which patients are treated, examined or cared for.