Medical Devices - Quality Management Systems

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.

 

Certification of Medical Devices & CE Marking

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.

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.  

 

Certification schemes for the four different classes of devices:

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:

 

Scope of notification

SIQ acts as a notified conformity assessment body with ID no. 1304 under the Medical Device Directive 93/42/EEC (MDD). The scope of notification (types of medical devices and conformity assessment models) is evident from the following table

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

 

MD 0102

Non-active devices for injection, infusion, transfusion and dialyses

X

 

 

X

X

Only devices for injection, infusion, transfusion

MD 0103

Non-active orthopaedic and rehabilitation devices

X

 

 

X

X

 

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 0107

Contraceptive medical devices

X

 

 

X

 

 

MD 0108

Non-active medical devices for disinfecting, cleaning, rinsing

X

 

 

X

 

 

MD 0110

Non-active medical devices for ingestion

X

 

 

X

 

 

MD 0200

Non-active implants

II

III

IV

V

VI

 

MD 0202

Non-active orthopaedic implants

X

 

 

X

 

 

MD 0300

Devices for wound care

II

III

IV

V

VI

 

MD 0301

Bandages and wound dressing

X

 

 

X

X

 

MD 0302

Suture materials and clamps

X

 

 

X

X

 

MD 0303

Other medical devices for wound care

X

 

 

X

X

 

MD0400

Non-active dental devices and accessories

II

III

IV

V

VI

 

MD0401

Non-active dental equipment and instruments

X

 

 

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

Only respiratory devices included

MD 1103

Devices for stimulation or inhibition

X

X

X

X

X

 

MD 1104

Active surgical devices

X

 

 

X

X

 

MD 1105

Active ophthalmologic devices

X

X

X

X

X

Anex III and VI for lasers

MD 1106

Active dental devices

X

X

X

X

X

Anex III and VI for lasers

MD 1107

Active devices for disinfection and sterilization

X

 

 

X

X

 

MD 1109

Active devices for patient positioning and transport

X

 

 

X

X

 

MD1111

Software

X

 

 

X

X

 

MD1200

Devices for imaging

II

III

IV

V

VI

 

MD1201

Imaging devices utilising ionizing radiation

X

 

 

X

X

 

MD1202

Imaging devices utilising non-ionizing radiation

X

X

X

X

X

 

MD 1300

Monitoring devices

II

III

IV

V

VI

 

MD 1301

Monitoring devices of non-vital physiological parameters

X

X

X

X

X

 

MD 1302

Monitoring devices of vital physiological parameters

X

X

X

X

X

 

MD 1400

Devices for radiation therapy and thermotheapy

II

III

IV

V

VI

 

MD 1402

Devices utilising non—ionizing radiation

X

 

 

X

X

 

  

MDS 7000

Specifics of Medical Devices

Limitations

MDS 7001

Medical devices incorporating medicinal substances, according to Directive 2001/83/EC

 

MDS 7004

Medical devices referencing the Directive 2006/42/EC on machinery

X

MDS 7006

Medical devices in sterile conditions

formaldehyde sterilization excluded

MDS 7010

Medical devices incorporating software / utilising software / controlled by software

 

 

 

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