芬兰
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Legislation |
Standard |
Product range |
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93/42/EEC Medical devices |
EN ISO/IEC 17021 |
Certification of management systems |
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EN ISO/IEC 17025 |
Testing and calibration laboratories |
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MD 0100 |
General non-active, non-implantable |
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MD 0101 |
Non-active devices for anaesthesia, |
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MD 0102 |
Non-active devices for injection, infusion, |
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MD 0103 |
Non-active orthopaedic and rehabilitation |
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MD 0104 |
Non-active medical devices with |
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MD 0105 |
Non-active ophthalmologic devices |
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MD 0106 |
Non-active instruments |
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MD 0108 |
Non-active medical devices for |
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MD 0110 |
Non-active medical devices for ingestion |
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MD 0200 |
Non-active implants |
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MD 0202 |
Non-active orthopaedic implants |
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MD 0300 |
Devices for wound care |
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MD 0301 |
Bandages and wound dressings |
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MD 0302 |
Suture material and clamps |
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MD 0303 |
Other medical devices for wound care |
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MD 0400 |
Non-active dental devices and accessories |
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MD 0401 |
Non-active dental equipment and |
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MD 0402 |
Dental materials |
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MD 0403 |
Dental implants |
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MD 1100 |
General active medical devices |
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MD 1102 |
Respiratory devices, devices including |
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MD 1103 |
Devices for stimulation or inhibition |
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MD 1104 |
Active surgical devices |
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MD 1105 |
Active ophthalmologic devices |
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MD 1106 |
Active dental devices |
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MD 1107 |
Active devices for disinfection and |
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MD 1108 |
Active rehabilitation devices and active |
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MD 1109 |
Active devices for patient positioning and |
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MD 1111 |
Software |
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MD 1112 |
Medical gas supply systems and parts |
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MD 1200 |
Devices for imaging |
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MD 1201 |
Imaging devices utilising ionizing |
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MD 1202 |
Imaging devices utilising non-ionizing |
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MD 1300 |
Monitoring devices |
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MD 1301 |
Monitoring devices of non-vital |
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MD 1302 |
Monitoring devices of vital physiological |
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MD 1400 |
Devices for radiation therapy and thermo |
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MD 1401 |
Devices utilising ionizing radiation |
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MD 1402 |
Devices utilising non-ionizing radiation |
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MD 1403 |
Devices for hyperthermia / hypothermia |
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MD 1404 |
Devices for (extracorporal) shock-wave |
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Horizontal technical competence |
MDS 7004 |
Medical devices referencing the Directive 2006/42/EC on machinery |
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MDS 7006 |
Medical devices in sterile condition |
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MDS 7010 |
Medical devices incorporating software /utilising software /controlled by software |
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Regulation (EU) 2017/745 on medical devices |
MDA 0201 |
Active non-implantable imaging devices |
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MDA 0202 |
Active non-implantable imaging devices |
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MDA 0203 |
Active non-implantable devices for |
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MDA 0204 |
Other active non-implantable devices |
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MDA 0301 |
Active non-implantable devices utilising |
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MDA 0303 |
Active non-implantable devices utilising |
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MDA 0304 |
Active non-implantable devices for |
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MDA 0305 |
Active non-implantable devices for |
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MDA 0307 |
Active non-implantable respiratory |
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MDA 0309 |
Active non-implantable ophthalmologic |
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MDA 0311 |
Active non-implantable dental devices |
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MDA 0313 |
Active non-implantable prostheses, |
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MDA 0315 |
Software |
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MDA 0317 |
Active non-implantable devices for |
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MDA 0318 |
Other active non-implantable devices |
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MDN 1205 |
Non-active non-implantable |
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MDN 1207 |
Non-active non-implantable diagnostic devices |
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MDN 1208 |
Non-active non-implantable instruments |
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MDN 1211 |
Non-active non-implantable devices for |
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MDN 1214 |
General non-active non-implantable |
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Horizontal technical competence |
MDS 1004 |
Devices which are also machinery as defined in point (a) of the second |
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MDS 1005 |
Devices in sterile condition |
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MDS 1007 |
Devices incorporating or consisting of nanomaterial |
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MDS 1009 |
Devices incorporating software/utilising software/controlled by software, |
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MDS 1010 |
Devices with a measuring function |
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MDS 1011 |
Devices in systems or procedure packs |
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MDS 1012 |
Products without an intended medical purpose listed in Annex XVI to |
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MDS 1014 |
Devices incorporating as an integral part an in vitro diagnostic device |
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MDT 2001 |
Devices manufactured using metal processing |
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MDT 2002 |
Devices manufactured using plastic processing |
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MDT 2003 |
Devices manufactured using non-metal mineral processing (e.g. glass,ceramics) |
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MDT 2004 |
Devices manufactured using non-metal non-mineral processing (e.g. textiles, |
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MDT 2006 |
Devices manufactured using chemical processing |
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MDT 2008 |
Devices manufactured in clean rooms and associated controlled environments |
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MDT 2010 |
Devices manufactured using electronic components including communication devices |
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MDT 2011 |
Devices which require packaging, including labelling |
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MDT 2012 |
Devices which require installation, refurbishment |
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2014/30/EU Electromagnetic compatibility |
EN ISO/IEC 17065 |
Product certification |
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Regulation (EU) No 305/2011 - Construction products |
EN 1090-1:+A1 |
98/214/EC |
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EN 50575:/A1 |
2011/284/EU |
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2014/68/EU Pressure equipment |
EN ISO/IEC 17020 |
Inspection |