MDR: 35 Notified Bodies on NANDO

The NANDO database newly listed 35 Notified Bodies under the MDR! INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. has been the latest NB notified under the Regulation (EU) 2017/745 on medical devices – MDR:


trida Tomase Bati 299

Louky, 76302 ZLIN

Country : Czech Republic


Phone : +420-572 779 912

Fax : –


Email :

Website :


Notified Body number : 1023

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

  • MDN 1104 Non-active soft tissue and other implants
    • Excluding IUD, breast implants and non-absorbable dermal fillers based on methylmethacrylate nad silicones
  • MDS 1012 Products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745
    • Excluding products intended to be totally or partially introduced into the human body through surgically invasive means for the purpose of modifying the anatomy or fixation of body parts. Excluding equipment intended to be used to reduce, remove or destroy adipose tissue, such as equipment for liposuction, lipolysis or lipoplasty.

Under the designation scope without limitations:

  • MDS 1001 Devices incorporating medicinal substances
  • 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 (1)
  • 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
  • MDT 2009 Devices manufactured using processing of materials of human, animal, or microbial origin
    • including only devices manufactured using processing of materials of microbial origin

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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