MDR: 30 Notified Bodies on NANDO

The NANDO database newly listed 30 Notified Bodies under the MDR!

Berlin Cert Prüf- und Zertifizierstelle für Medizinprodukte GmbH has been the latest NB notified under the Regulation (EU) 2017/745 on medical devices – MDR.

Berlin Cert Prüf- und Zertifizierstelle für Medizinprodukte GmbH
Dovestraße 6
10587 Berlin
Country: Germany

Phone: +49 30 5858 216-0 (Zentrale)
Fax: +49 30 314-23719

Email: cert@berlincert.de
Website: http://www.berlincert.de

Notified Body number: 0633

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

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

• MDA 0202 Active non-implantable imaging devices utilising non-ionizing radiation
• 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 0302 Active non-implantable devices utilising non-ionizing radiation
• MDA 0305 Active non-implantable devices for stimulation or inhibition
• MDA 0306 Active non-implantable devices for extra-corporal circulation, administration or removal of substances and haemapheresis
  
  • Ohne aktive Produkte, die dazu bestimmt sind, Arzneimittel, Körperflüssigkeiten oder andere Stoffe an den Körper abzugeben und/oder aus dem Körper zu entfernen, wenn diese Vorgehensweise unter Berücksichtigung der Art der betreffenden Stoffe, des betreffenden Körperteils und der Art der Anwendung eine potenzielle Gefährdung darstellt (Regel 12 Anhang VIII Verordnung (EU) 2017/745)
    (Excluding active devices intended to deliver or remove medicines, body fluids, or other substances to or from the body when this represents a potential hazard due to the type of substances involved, the body part, and the mode of application (Rule 12 Annex VIII Regulation (EU) 2017/745))
• MDA 0307 Active non-implantable respiratory devices
• MDA 0309 Active non-implantable ophthalmologic devices
• MDA 0310 Active non-implantable devices for ear, nose and throat
• MDA 0311 Active non-implantable dental devices
• 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 0315 Software
• MDA 0316 Medical gas supply systems and parts thereof
• MDA 0317 Active non-implantable devices for cleaning, disinfection and sterilisation
• MDA 0318 Other active non-implantable devices
• MDN 1205 Non-active non-implantable orthopaedic and rehabilitation devices
• MDN 1207 Non-active non-implantable diagnostic devices
• MDN 1208 Non-active non-implantable instruments
• MDN 1214 General non-active non-implantable devices used in health care and other non-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)
• MDS 1006 Reusable surgical instruments
• 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 1011 Devices in systems or procedure packs
• MDS 1012 Products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745
• …

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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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