Medical Devices Directive 93/42/EEC
The following information is a summary of the requirements of the Directive.
The Medical Devices Directive is due to be replaced by the Medical Devices Regulation in 2021.
The main differences between the Directive and the Regulation are as follows:
- Wider and clearer scope of EU legislation, extended to include, for example, implants for aesthetic purposes, and clarified as regards genetic tests;
- Stronger supervision of independent conformity assessment bodies (so called notified bodies’) by national authorities;
- More powers for notified bodies vis-à-vis the manufacturers, to ensure thorough testing and regular checks, including unannounced factory inspections at manufacturing sites;
- Clearer rights and responsibilities for manufacturers, authorised representatives, importers and distributors, including in the case of diagnostic services and internet sales;
- Extended database on medical devices (Eudamed), providing comprehensive and public information on products available on the EU market;
- Better traceability of devices throughout the supply chain, enabling a swift and effective response to safety concerns (e.g. recalls);
- Reinforced rules for clinical investigations on devices and the required clinical data for the pre-market and the continuous post-market assessment of medical devices, including in vitro diagnostic medical devices.
- Adaptation of the general health and safety requirements, including labelling provisions, to the technological and scientific progress.
- Introduction of classification rules that divide the broad range of in vitro diagnostic medical devices into four different risk classes as it already exists for other medical devices.
- Creation of a Medical Device Coordination Group composed of members representing national competent authorities in the field of medical devices to ensure better coordination between Member States, with the Commission providing the necessary scientific, technical and logistic support.
The basic structure and requirements of the Regulation remain the same as for the Directive, with medical devices being grouped into four risk categories based on a set of classification rules, and the level of external assessment required for CE marking increasing with the risk.
The Medical Devices Directive 93/42/EEC, along with two associated directives (the Active Implantable Medical Devices Directive and the In Vitro Diagnostic Devices Directive) cover all medical equipment. This 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. The Directive excludes any products which come within the scope of one of the other two medical device directives.
The Medical Devices Directive has a very wide scope and it is important to realize that the intended purpose and the way a product is marketed can cause them to be covered or excluded. The Directive defines and applies different administrative requirements to four classifications of medical device. These classifications are based on the risk a device presents to the public, as defined through a series of classification rules.
The Directive came fully into force in June 1998 and is enforced in the UK by the Medicines and Healthcare products Regulatory Agency (MHRA).
The Medical Devices Directive was enacted to provide for a harmonised regulatory environment for all medical 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 CE marked to show that they comply. Such products may then be freely sold throughout the EEA without being subject to additional national regulations.
The Medical Devices Directive is one of a suite of three directives which together cover all medical equipment. The associated directives are the Active Implantable Medical Devices Directive (AIMDD) and the In Vitro Diagnostic Devices Directive (IVDD).
The Directive defines 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, 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.”
Clearly the scope of the Directive is extremely wide and potentially there is overlap with other Directives. However, the MDD includes provisions for all relevant hazards, including mechanical and electrical safety and provisions for electromagnetic compatibility. Devices which fall within the scope of the MDD, the AIMDD and the IVDD are 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.
It is also important to realise that some equipment may fall into or out of the scope of the MDD solely on the basis of the purpose to which the equipment is intended to be put and the way it is marketed. Basically, if the manufacturer makes any claims that the equipment has therapeutic effects or alleviates the symptoms of any disability, injury or illness, the equipment is within the scope of the MDD and (at the very least) product registration and appropriate documentation are required.
Examples of products which are considered to be medical devices include:
- Medicine measuring cups
- Dental instruments
- Prescription spectacles and contact lenses
- Bandages and splints
- Dental treatment chairs
- First aid kits
Equipment which (in the UK at least) is not considered to fall within the scope of the Medical Devices Directive 93/42/EEC includes:
- Baby nappies
- Intense Pulsed Light (IPL) therapy for, for example, hair removal.
- Sunglasses (which are covered under the Protective Personal Equipment Directive)
- “Consumer products aimed at comfort”
- “Products for sport or leisure”
- Cosmetic products, including tooth whitening products
An example of equipment which may or may not be within the scope of the MDD depending on the purpose for which they are marketed are protective gloves – those intended for use in direct contact with patients will be considered as medical devices while those used (for instance) in a medical laboratory are considered to be PPE.
The Directive applies different administrative requirements to devices depending on the risk which they present to the user. There are four classifications:
- Class I – generally regarded as low risk
- Class IIa – generally regarded as medium risk
- Class IIb – generally regarded as medium risk
- Class III – generally regarded as high risk
Once it has been decided that a device falls within the scope of the Medical Devices Directive, the actual classification of an appliance is determined by a series of rules which are laid out in annex IV to the Directive. Essentially these start by saying that anything which is not covered by one of the other rules is a class I device, and then go on to give more detailed rules for the classification of other equipment. Typical factors upon which the rules decide are whether the device is intended for long term or short term use, whether it involves the use of associated pharmaceuticals and chemicals, whether it is invasive in normal bodily orifices or via surgical insertion, and whether it operates by the exchange of energy with the body. Definitions of terms used to describe these factors are also included in the annex.
Caution: This is not an exhaustive list of the factors covered in the rules; these rules are complex and should be considered carefully in the light of a specific application.
For Class I devices, custom made devices, devices for clinical investigation and procedure packs the Manufacturer must be registered with the Competent Authority in the Member State where they are resident. The Competent Authority will only register manufacturers who are resident in their own territory so if the manufacturer is not based within the EEA, then they must appoint someone who is to act as their Authorised Representative and their name and address must appear on the product instead of the manufacturer’s.
In the UK, the Competent Authority is the Medicines and Healthcare Regulatory Agency (MHRA).
Manufacturers of class II and higher devices are not required to register because they will have a relationship with an EU based Notified Body, but they are still required to provide an address within the Community on their products.
Annex 1 of the Directive lays down a series of essential requirements for the design of medical devices. The Essential Requirements of the Directive apply to all medical devices:
- 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 (for devices with a measuring function)
- 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 Medical Devices Directive 93/42/EEC.