MDR: 31 Notified Bodies on NANDO

The NANDO database newly listed 31 Notified Bodies under the MDR!

AGENCIA ESPAÑOLA DE MEDICAMENTOS Y PRODUCTOS SANITARIOS has been the latest NB notified under the Regulation (EU) 2017/745 on medical devices – MDR.

AGENCIA ESPAÑOLA DE MEDICAMENTOS Y PRODUCTOS SANITARIOS
Campezo 1. Edificio 8
28022 MADRID
Country : Spain

Phone : +34:91:822 52 52
Fax : +34:91:822 52 89

Email : on0318@aemps.es
Website : –

Notified Body number : 0318

You can find the full scope of its notification on the following link.

Below, an extract from NANDO, where conditions/limitations are listed:

• MDA 0201 Active non-implantable imaging devices utilising ionizing radiation
  
  • Limited to x-ray medical devices, gamma cameras and positron emission tomography
• MDA 0302 Active non-implantable devices utilising non-ionizing radiation
  • Limited to medical devices for magnetotherapy and microwaves
• MDA 0309 Active non-implantable ophthalmologic devices
  • Limited to diagnostic medical devices
• MDN 1101 Non-active cardiovascular, vascular and neurovascular implants
  • Limited to stents, sutures for cardiovascular surgery, and implantable drug delivery systems
• MDN 1104 Non-active soft tissue and other implants
  • Neurological, neurosurgical and breast implants are excluded
• MDN 1202 Non-active non-implantable devices for administration, channelling and removal of substances, including devices for dialysis
  • Annex X limited to medical devices for puncture, injection and/or extraction of fluids
• MDN 1211 Non-active non-implantable devices for disinfecting, cleaning and rinsing
  • Annex X limited to contact lens care products
• MDS 1003 Devices manufactured utilising tissues or cells of animal origin, or their derivatives
  • Excluding medical devices utilising tissues or cells of animal origin under Regulation (UE) No. 722/2012
• MDS 1005 Devices in sterile condition
  • Including aseptic processing, ethylene oxide gas sterilisation (EOG), low temperature steam and formaldehyde sterilisation, moist heat sterilisation, radiation sterilisation (gamma, x-ray, electron beam)
• MDT 2009 Devices manufactured using processing of materials of human, animal, or microbial origin
  • Excluding human and animal material of Regulation (UE) No. 722/2012

Under the designation scope without limitations:

• MDA 0203 Active non-implantable devices for monitoring of vital physiological parameters
• MDA 0204 Other active non-implantable devices for monitoring and/or diagnosis
• MDA 0312 Other active non-implantable surgical devices
• MDA 0313 Active non-implantable prostheses, devices for rehabilitation and devices for patient positioning and transport
• MDA 0314 Active non-implantable devices for processing and preservation of human cells, tissues or organs including in vitrofertilisation (IVF) and assisted reproductive technologies (ART)
• MDA 0315 Software
• MDA 0316 Medical gas supply systems and parts thereof
• MDA 0318 Other active non-implantable devices
• 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)
• …

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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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