MDR: 37th Notified Body on NANDO!

The NANDO database has a new Notified Body under the MDR!

SLG PRÜF UND ZERTIFIZIERUNGS GMBH is the 37th EU Notified Body under the Regulation (EU) 2017/745 on medical devices – MDR:

Burgstädter Strasse 20
09232 Hartmannsdorf
Country: Germany

Phone: +49:3722:7323-0
Fax: +49:3722:7323-899


Notified Body number: 0494

You can find the full scope of its notification on the following link. Below, an extract from NANDO, where conditions/limitations are listed:

Codes reflecting the design and intended purpose of the device

A. Active devices

2. Active non-implantable devices for imaging, monitoring and/or diagnosis

  • MDA 0201 Active non-implantable imaging devices utilising ionizing radiation
    • Restricted to X-ray diagnostics, scintigraphy
  • MDA 0203 Active non-implantable devices for monitoring of vital physiological parameters
  • MDA 0204 Other active non-implantable devices for monitoring and/or diagnosis

3. Active non-implantable therapeutic devices and general active non-implantable devices

  • MDA 0302 Active non-implantable devices utilising non-ionizing radiation
  • MDA 0303 Active non-implantable devices utilising hyperthermia/hypothermia
    • Excluding devices for external whole-body hyperthermia therapy and hyperthermic perfusion
  • MDA 0305 Active non-implantable devices for stimulation or inhibition
  • MDA 0307 Active non-implantable respiratory devices
    • Excluding devices for emergency medicine and anesthesia
  • MDA 0308 Active non-implantable devices for wound and skin care
  • MDA 0309 Active non-implantable ophthalmologic devices
  • MDA 0312 Other active non-implantable surgical devices
    • Restricted to products for minimally invasive surgery
  • MDA 0313 Active non-implantable prostheses, devices for rehabilitation and devices for patient positioning and transport
    • Excluding prostheses
  • MDA 0315 Software
  • MDA 0316 Medical gas supply systems and parts thereof
    • Restricted to central gas supply according to EN ISO 7396
  • MDA 0318 Other active non-implantable devices

Horizontal technical competence

  • MDS 1004 Devices which are also machinery as defined in point (a) of the second paragraph of Article 2 of Directive 2006/42/EC of the European Parliament and of the Council
  • MDS 1009 Devices incorporating software/utilising software/controlled by software, including devices intended for controlling, monitoring or directly influencing the performance of active or active implantable devices
  • MDS 1010 Devices with a measuring function
    • Restricted to products included in the scope
  • MDS 1011 Devices in systems or procedure packs
    • Restricted to products included in the scope
  • MDS 1012 Products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745
    • Without Regulation (EU) 2017/745 Appendix XVI paragraph 1.; 2.; 3.; 4. restricted to products included in the scope
  • MDT 2001 Devices manufactured using metal processing
  • MDT 2002 Devices manufactured using plastic processing
  • MDT 2003 Devices manufactured using non-metal mineral processing (e.g. glass, ceramics)
  • MDT 2004 Devices manufactured using non-metal non-mineral processing (e.g. textiles, rubber, leather, paper)
  • MDT 2010 Devices manufactured using electronic components including communication devices
  • MDT 2011 Devices which require packaging, including labelling
    • Excluding sterile packaging
  • MDT 2012 Devices which require installation, refurbishment
  • MDT 2013 Devices which have undergone reprocessing
    • Restricted to products that need to be reprocessed for use, excluding single-use devices

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