MDD


Medical Devices Directive

1. THE MEDICAL DEVICES

1.1. Definition

The medical devices are products that can very seriously influence the health and safety to users and other persons and therefore they undergo strict EU regulation in the stage of introduction to EU market. According to their nature and especially function, they are subjects to three EU Directives and other legislative documents:

93/42/EEC Directive medical devices MD
90/385/EEC Directive active implantable medical devices AIMD
98/79/EC Directive in-vitro diagnostic medical devices IVD
2002/364/EC Decision common technical specification for IVD

Practically all means used by physicians for diagnostic and treatment of ill patients or injured people are medical devices, provided that they are not medicinal drugs. The more exact definition is given by the MD directive:

The medical device is any instrument, material or other article (including controlling software) intended by the manufacturer for the purpose of:
  Diagnosis, prevention, monitoring, treatment or alleviation of human 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.

1.2. Scope of the MD Directive 93/42/EEC

The MD Directive applies to medical devices and their accessories, which for the purposes of this Directive are treated as ordinary medical devices.

Excluded from scope of medical devices;
  Custom-made MD (tailored to individual patient, individual handicap or injury)
  MD intended exclusively for the purposes of clinical trials (they 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)
  Active implantable AIMD
  In-Vitro Diagnostics IVD.

Examples of products which are the medical devices include:
  Medicine measuring cups
  Syringes
  Dental instruments
  Stethoscopes
  Thermometers
  Prescription spectacles and contact lenses
  Bandages and splints
  Dental treatment chairs
  Wheelchairs
  Condoms
  First aid kits
  Surgical needles

Examples of products which are not the medical devices include:
  Toothbrushes
  Baby nappies
  Mouth guards
  Sunglasses (which are covered under the Protective Personal Equipment Directive),     unless they have a corrective action - lenses
  Breath analysers
  Products for sport or leisure (arm or leg protectors)
  Cosmetic
  Medicinal drugs
  "Living" transplants of human or animal origin

Examples of equipment which may or may not be medical devices 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 personal protective equipment PPE. Similar situation occurs in the case of the protective glasses or goggles - without optical corrective actions they are PPE, however in case of incorporated corrective lenses, they are both PPE and medical devices

1.3. Classification of Medical Devices

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

1.4. Essential requirements and supplier registration:

The essential requirements of the Directive apply to all medical devices. The most basic requirement is for the manufacturer or his authorised representative in the EU to register with the appropriate agency in the country in which he is based.

This makes the all Medical Devices Directives different from all the other New Approach Directives in that there is actually a specific provision which requires manufacturers and suppliers of devices to appoint a representative within the EU, and for that representative to be registered with an appropriate government agency.

The safety requirements are specified extensively in the Annex I of the 93/42/EEC.

1.5. Conformity Assessment

Additionally, the different classifications of device are subject to different conformity assessment regimes, as follows:
  CLASS I devices are subject only to the manufacturer's responsibility for requirements     laid out above. Exception are sterile products and measuring devices which are also     subjected to a limited degree of Notified Body participation which consists of a type     approval and the audit of a quality system and manufacturing process
  CLASS IIA devices are subject to all the requirements for Class I devices, and     additionally the manufacturer is required to undergo an audit of his production quality     assurance system by a Notified Body. The type approval of the product is often     required.
  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.     In most cases, type approval of the product by a notified body is an integral part of the     quality system approval.
  CLASS III devices are subject to the same requirements as Class IIb devices but     additionally the manufacturer must submit a design technical documentation to a     notified body for approval.

1.6. Vigilance procedures

One of the other provisions, which distinguishes the Medical Device Directives from the other New Approach Directives is that they establish a formal vigilance procedure. In the frame of vigilance the manufacturers, health professionals and others must report certain problems occurred by the use of medical devices and in clinical trials. This vigilance system is administered by the national competent authority in each of the member states. As regard the manufacturer, he shall have a procedure for post market surveillance and reporting of adverse incidents.

Post market activity is of course deviation from the New Approach, caused by extremely high risks in connection to use of medical devices.