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:

SLG PRÜF UND ZERTIFIZIERUNGS GMBH
Burgstädter Strasse 20
09232 Hartmannsdorf
Country: Germany

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

Email: service@slg.de.com
Website: http://www.slg.de.com

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