By adopting this quality management system, manufacturers and suppliers of medical devices demonstrate to the outside world that the medical devices they manufacture or provide meet essential requirements for safety and performance, i.e., that their medical devices will not compromise the clinical condition or safety of patients, or of other users of medical devices..

The system stresses the importance of the control of products and processes consistent with the regulatory requirements for medical devices defined in relevant directives and rules, good business practice given in the ISO 13485:2003 standard, and specific requirements of standards for individual medical devices or processes.

It is due to the specificity of the use of medical devices and their direct impact on the safety and health of persons that the production and trade in medical devices are severely regulated within the European Union, i.e. defined in Medical Device Directive 93/42/EEC (MDD) that has been transposed into the national legislations of EU member states. The aim of the MD Directive, as one of the New Approach directives, is to harmonize legislations and administrative requirements of the EEA members (European Economic Area) concerning safety, health protection and performance characteristics of medical devices.

Manufacturers must ensure the compliance of their devices with the provisions of the Medical Device Directive before affixing the CE marking on them and placing them on the EEA market.Under the Medical Device Directive, conformity assessment procedures are carried out by notified bodies, i.e. qualified and competent impartial organizations designated by competent national authorities and notified to the European Commission.

Duration of contact with the body, degree of invasiveness, source of power, and place of application of a medical device are the criteria for assigning medical devices in one of the following four classes: class I for low risk devices, classes IIa and IIb for medium risk devices, and class III for high risk devices.

Please read Information for custumers for details concerning the medical device certification procedure.

Various conformity assessment procedures or routs are available to manufacturers and notified bodies under the Medical Device Directive. Their selection, however, is not unlimited but depends on the class a medical device has been assigned to.  

SIQ acts as a notified conformity assessment body with ID no. 1304 under the Medical Device Directive. The scope of notification (types of medical devices and conformity assessment models) is evident from the following table:

• Class I devices (pdf)
• Class IIa devices (pdf)
• Class IIb devices (odf)
• Class III devices (pdf)

MD 0000	Medical Devices, Non-Active	Annexes					Limitations
MD 0100	General non-active, non-implantable medical devices	II	III	IV	V	VI
MD 0101	Non-active devices for anaesthesia, emergency and intensive care	X			X	X	only tracheal tubes, urinary catheters, tubing for anaesthesia included
MD 0102	Non-active devices for injection, infusion, transfusion and dialyses	X			X	X	non-active devices for dialyses and class III devices excluded
MD 0104	Non-active medical devices with measuring function	X			X	X
MD 0105	Non-active ophthalmologic devices	X			X	X
MD 0106	Non-active instruments	X			X	X
MD 0200	Non-active implants	II	III	IV	V	VI
MD 0202	Non-active orthopaedic implants	X			X	X	hips excluded
MD 0300	Devices for wound care	II	III	IV	V	VI
MD 0301	Bandages and wound dressing	X			X
MD 0302	Suture materials and clamps	X			X
MD 1000	Medical Devices, Active	Annexes					Limitations
MD 1100	General active medical devices	II	III	IV	V	VI
MD 1101	Devices for extra-corporal circulation, infusion and haemopheresis	X			X	X	only infant icubators included
MD 1102	Respiratory devices, devices including hyperbaric chambers for oxygen therapy, inhalation anaesthesia	X			X	X	hyperbaric chambers for oxygen therapy, inhalation anaesthesia excluded
MD 1103	Devices for stimulation or inhibition	X			X	X
MD 1104	Active surgical devices	X			X	X	only lasers for medical use included
MD 1105	Active ophthalmologic devices	X			X	X	only lasers for medical use included
MD 1106	Active dental devices	X			X	X	only lasers for medical use included
MD 1107	Active devices for desinfection and sterilization	X			X	X
MD 1300	Monitoring devices	II	III	IV	V	VI
MD 1301	Monitoring devices of non-vital physiological parameters	X			X	X
MD 1302	Monitoring devices of vital physiological parameters	X			X	X
MDS 7000	Specifics of Medical Devices	Select		Limitations
MDS 7004	Medical devices referencing the Directive 2006/42/EC on machinery	X
MDS 7006	Medical devices in sterile conditions	X

 

 

• Guidance MEDDEVs
• Directive 93/42/EEC
• ISO 13485:2003
• Certification of medical devices
• Testing of electrical medical devices