MDR: 28 Notified Bodies on NANDO

The NANDO database newly listed 28 Notified Bodies under the MDR!

SLOVENIAN INSTITUTE OF QUALITY AND METROLOGY – SI has been the latest NB notified under the Regulation (EU) 2017/745 on medical devices – MDR.

SLOVENIAN INSTITUTE OF QUALITY AND METROLOGY – SI

Mašera – Spasićeva ulica 10
1000 LJUBLJANA
Country : Slovenia

Phone : +386 1 4778 000
Fax : +386 1 4778 444

Email : info@siq.si
Website : http://www.siq.si/

Notified Body number : 1304

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

• MDA 0309 Active non-implantable ophthalmologic devices
  • Annex X and XI(B) for lasers only. Other annexes with no limitations
• MDA 0311 Active non-implantable dental devices
  • Annex X and XI(B) for lasers only. Other annexes with no limitations.
• MDN 1104 Non-active soft tissue and other implants
  
  • Nonabsorbable sutures only
• MDN 1202 Non-active non-implantable devices for administration, channelling and removal of substances, including devices for dialysis
  
  • Devices for dialysis excluded
• MDS 1005 Devices in sterile condition
  
  • Aseptic processing, filtration, steam, EtO, irradiation included
• MDS 1008 Devices utilising biologically active coatings and/or materials or being wholly or mainly absorbed or locally dispersed in the human body or are intended to undergo a chemical change in the body
  
  • Biologically active coatings/materials excluded
• MDS 1013 Class III custom-made implantable devices
  
  • Orthopaedic implantable devices only

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Have a look at the Analysis of NB Designation prepared by our partners AKRA TEAM. You will find it in our dedicated Library of Documents – Notified Body: MDR and IVDR.

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