The following information is a summary of the requirements of the Directive. It is not an area in which we currently offer advice but you may find some useful information and links here.
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).
- Active Implantable Medical Devices Directive
- In-Vitro Diagnostic Medical Devices Directive
- Importing CE marked Medical Devices into the UK
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.”
Custom-made devices and those intended exclusively for the purposes of clinical trials are excluded from certain of the Directive's administrative provisions, although they must still meet the essential safety requirements and may only be applied to patients by clinical specialists.
Also excluded from the provisions of the Medical Devices Directive (MDD) are medical products which fall within the scope of the AIMDD and the IVDD although clearly they are subjected to equally stringent controls under other directives or national legislation.
Medicinal products, cosmetics, human blood products and transplant tissue are also excluded.
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 MDD 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 Single Market
While in theory article 100a of the Treaty of Rome (now actually article 95 of the Treaty of Amsterdam) should ensure that legislation governing CE marked products is the same across the whole of the EEA, the reality is that the regulations implementing and enforcing the Directives are drafted individually in each Member State and do sometimes interpret the Directives differently. This can mean that different CE marking requirements need to be met in different countries. A good example of this in relation to medical devices can be found in connection with medical gas pipelines and accessories. In the UK these products are treated by the Competent Authority as part of the infra-structure of the medical institution, much the same as heating or water pipes, and as such they do not need CE marking under the Directive. Certain other EEA countries, however, do regard them as medical device accessories (as they are connected to medical devices) and do require them to be CE marked. With complex apparatus such as this, it is important to check the interpretation of the Directive in every country in which a product is to be marketed. Complying with the regulations of one Member State does not automatically guarantee compliance in others, and it does not ensure against interference from other Competent Authorities or even from prosecution.
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 investigationand 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 Directive.
In addition to Registration, manufacturers (or their agents) must typically
- comply with the essential requirements of annex 1 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)
Additionally, the different classifications of device are subject to different conformity regimes, as follows:
- CLASS I devices are subject only to the requirements laid out above, except for sterile products and measuring devices which are also subjected to a limited degree of notified body intervention relating to those aspects of the device affecting the sterility or the measuring function. Intervention is likely to consist of a type approval and the audit of a quality systems and manufacturing processes.
- CLASS IIA devices are subject to all the requirements for Class I devices, and additionally the manufacturer is required to undergo an audit of their production quality assurance scheme by a notified body. There are several options for this audit which does not necessarily require a fully fledged ISO9000-style quality management system but will require type approval of the product.
- CLASS IIb devices are subject to all the requirements for Class I devices, and in addition the manufacturer is required to maintain a full quality assurance system covering all aspects of production from design through to final examination and testing. For practical purposes this means compliance with EN ISO 13485. In most cases, type approval of the product by a notified body is an integral part of the quality system registration.
- CLASS III devices are subject to the same requirements as Class IIb devices but additionally the manufacturer must submit a design dossier to a notified body for approval.
One of the other 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 vigilance procedure is established by the Directive, through which manufacturers, their Authorised Representatives, 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 was brought into force with effect from 1 January 1995. Transitional arrangements permitted equipment which complied with national regulations to be sold until 14 June 1998.