Notification of a Body in the framework of a

technical harmonization directive

From: Ministry of Economy – DG Product Safety To: European Commission

and Inspection GROWTH Directorate-General
Inönü Bulvari No:36 200 Rue de la Loi,
Emek 06100 B-1049 Brussels.
Ankara
Türkiye
Other Member States

Reference: Legislation: 93/42/EEC Medical devices

Body name, address, telephone, fax, email, website :

UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A..
Mutlukent Mahallesi 2073 Sokak No:10 Umitkoy-CANKAYA
Ankara
Türkiye
00 90 312 443 03 90
00 90 312 443 03 76
yapi@udemltd.com.tr
www.udemltd.com.tr

Body info: NB 2292

Body:
Created: 2017-09-05

Last update: 2017-09-07

Name of National Accreditation Body (NAB):

TURKAK - Turkish Accreditation Agency

The accreditation covers the product categories and conformity assessment procedures
concerned by this notification: Yes

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Tasks performed by the Body:
Last approval date: 2021-05-10

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 Products Procedures Articles /Annexes Limitations

-*MD 0100 - General non-active, EC declaration of conformity (full quality Annex II

non-implantable medical devices assurance system) Annex V
-*MD 0101 - Non-active devices for EC declaration of conformity (production
anaesthesia, emergency and quality assurance)
intensive care

-*MD 0100 - General non-active, EC declaration of conformity (full quality Annex II

non-implantable medical devices assurance system) Annex V
-*MD 0102 - Non-active devices for EC declaration of conformity (production
injection, infusion, transfusion and quality assurance)
dialysis

-*MD 0100 - General non-active, EC declaration of conformity (full quality Annex II

non-implantable medical devices assurance system) Annex V
-*MD 0104 - Non-active medical EC declaration of conformity (production
devices with measuring function quality assurance)

-*MD 0100 - General non-active, EC declaration of conformity (full quality Annex II

non-implantable medical devices assurance system) Annex V
-*MD 0105 - Non-active EC declaration of conformity (production
ophthalmologic devices quality assurance)

-*MD 0100 - General non-active, EC declaration of conformity (full quality Annex II

non-implantable medical devices assurance system) Annex V
-*MD 0106 - Non-active instruments EC declaration of conformity (production
quality assurance)
-*MD 0100 - General non-active, EC declaration of conformity (full quality Annex II
non-implantable medical devices assurance system) Annex V
-*MD 0107 - Contraceptive medical EC declaration of conformity (production
devices quality assurance)

-*MD 0100 - General non-active, EC declaration of conformity (full quality Annex II

non-implantable medical devices assurance system) Annex V
-*MD 0108 - Non-active medical EC declaration of conformity (production
devices for disinfecting, cleaning, quality assurance)
rinsing

-*MD 0100 - General non-active, EC declaration of conformity (full quality Annex II

non-implantable medical devices assurance system) Annex V
-*MD 0110 - Non-active medical EC declaration of conformity (production
devices for ingestion quality assurance)

-*MD 0200 - Non-active implants EC declaration of conformity (full quality Annex II

-*MD 0201 - Non-active assurance system) Annex V
cardiovascular implants EC declaration of conformity (production
quality assurance)
-*MD 0200 - Non-active implants EC declaration of conformity (full quality Annex II
-*MD 0202 - Non-active orthopaedic assurance system) Annex V
implants EC declaration of conformity (production
quality assurance)
-*MD 0200 - Non-active implants EC declaration of conformity (full quality Annex II
-*MD 0203 - Non-active functional assurance system) Annex V
implants EC declaration of conformity (production
quality assurance)
-*MD 0200 - Non-active implants EC declaration of conformity (full quality Annex II
-*MD 0204 - Non-active soft tissue assurance system) Annex V
implants EC declaration of conformity (production
quality assurance)

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 Products Procedures Articles /Annexes Limitations

-*MD 0300 - Devices for wound EC declaration of conformity (full quality Annex II
care assurance system) Annex V
-*MD 0301 - Bandages and wound EC declaration of conformity (production
dressings quality assurance)

-*MD 0300 - Devices for wound EC declaration of conformity (full quality Annex II
care assurance system) Annex V
-*MD 0302 - Suture material and EC declaration of conformity (production
clamps quality assurance)

-*MD 0300 - Devices for wound EC declaration of conformity (full quality Annex II
care assurance system) Annex V
-*MD 0303 - Other medical devices EC declaration of conformity (production
for wound care quality assurance)

-*MD 0400 - Non-active dental EC declaration of conformity (full quality Annex II

devices and accessories assurance system) Annex V
-*MD 0401 - Non-active dental EC declaration of conformity (production
equipment and instruments quality assurance)

-*MD 0400 - Non-active dental EC declaration of conformity (full quality Annex II

devices and accessories assurance system) Annex V
-*MD 0402 - Dental materials EC declaration of conformity (production
quality assurance)
-*MD 0400 - Non-active dental EC declaration of conformity (full quality Annex II
devices and accessories assurance system) Annex V
-*MD 0403 - Dental implants EC declaration of conformity (production
quality assurance)
-*MD 1100 - General active EC declaration of conformity (full quality Annex II
medical devices assurance system) Annex V
-*MD 1101 - Devices for extra- EC declaration of conformity (production
corporal circulation, infusion and quality assurance)
haemopheresis

-*MD 1100 - General active EC declaration of conformity (full quality Annex II

medical devices assurance system) Annex V
-*MD 1102 - Respiratory devices, EC declaration of conformity (production
devices including hyperbaric quality assurance)
chambers for oxygen therapy,
inhalation anaesthesia

-*MD 1100 - General active EC declaration of conformity (full quality Annex II

medical devices assurance system) Annex V
-*MD 1103 - Devices for stimulation EC declaration of conformity (production
or inhibition quality assurance)

-*MD 1100 - General active EC declaration of conformity (full quality Annex II

medical devices assurance system) Annex V
-*MD 1104 - Active surgical devices EC declaration of conformity (production
quality assurance)
-*MD 1100 - General active EC declaration of conformity (full quality Annex II
medical devices assurance system) Annex V
-*MD 1105 - Active ophthalmologic EC declaration of conformity (production
devices quality assurance)

-*MD 1100 - General active EC declaration of conformity (full quality Annex II

medical devices assurance system) Annex V
-*MD 1106 - Active dental devices EC declaration of conformity (production
quality assurance)

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 Products Procedures Articles /Annexes Limitations

-*MD 1100 - General active EC declaration of conformity (full quality Annex II

medical devices assurance system) Annex V
-*MD 1107 - Active devices for EC declaration of conformity (production
disinfection and sterilisation quality assurance)

-*MD 1100 - General active EC declaration of conformity (full quality Annex II

medical devices assurance system) Annex V
-*MD 1108 - Active rehabilitation EC declaration of conformity (production
devices and active prostheses quality assurance)

-*MD 1100 - General active EC declaration of conformity (full quality Annex II

medical devices assurance system) Annex V
-*MD 1109 - Active devices for EC declaration of conformity (production
patient positioning and transport quality assurance)

-*MD 1100 - General active EC declaration of conformity (full quality Annex II

medical devices assurance system) Annex V
-*MD 1111 - Software EC declaration of conformity (production
quality assurance)
-*MD 1100 - General active EC declaration of conformity (full quality Annex II
medical devices assurance system) Annex V
-*MD 1112 - Medical gas supply EC declaration of conformity (production
systems and parts thereof quality assurance)

-*MD 1300 - Monitoring devices EC declaration of conformity (full quality Annex II

-*MD 1301 - Monitoring devices of assurance system) Annex V
non-vital physiological parameters EC declaration of conformity (production
quality assurance)
-*MD 1400 - Devices for radiation EC declaration of conformity (full quality Annex II
therapy and thermo therapy assurance system) Annex V
-*MD 1403 - Devices for EC declaration of conformity (production
hyperthermia / hypothermia quality assurance)

-*MD 1400 - Devices for radiation EC declaration of conformity (full quality Annex II
therapy and thermo therapy assurance system) Annex V
-*MD 1404 - Devices for EC declaration of conformity (production
(extracorporal) shock-wave therapy quality assurance)
(lithotripsy)

Horizontal technical competences 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:
*MDS 7006 - Medical devices in sterile condition: Including aseptic processing, ethylene oxide gas
sterilisation (EOG), moist heat sterilisation, radiation
sterilisation (gamma, x-ray, electron beam)
*MDS 7009 - Medical devices utilising biological active
coatings and/or materials or being wholly or mainly
absorbed:
*MDS 7010 - Medical devices incorporating software
/utilising software /controlled by software:

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