On 24 December 2025, Malta Conformity Assessment Ltd. was added to the NANDO database as a notified body for the Medical Devices Regulation (EU) 2017/745 (MDR). With this new designation, the number of notified bodies under the MDR has reached 52.
Malta Conformity Assessment Ltd.
Malta Life Sciences Park Sir Temi Zammit Buildings, Office LS2.1.11
San Gwann SGN 3000
Malta
+356 2138 0875
info@maltaca.com
www.maltaca.com
Body Number: 3132
The Notification covers the following:
- MDS 1001 Devices incorporating medicinal substances, excluding human blood derivatives
- 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
- Devices in sterile condition, limited to Aseptic processing, Ethylene oxide gas sterilisation (EOG), Moist heat sterilisation, Radiation sterilisation (gamma, x-ray, electron beam), Sterilisation with hydrogen peroxide
- MDS 1006 Reusable surgical instruments
- MDS 1007 Devices incorporating or consisting of nanomaterial
- 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
- 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
- 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
- MDS 1013 Class III custom-made implantable devices
- 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, excluding leather
- MDT 2005 Devices manufactured using biotechnology
- MDT 2006 Devices manufactured using chemical processing
- MDT 2007 Devices which require knowledge regarding the production of pharmaceuticals
- MDT 2008 Devices manufactured in clean rooms and associated controlled environments
- MDT 2010 Devices manufactured using electronic components including communication devices
- MDT 2011 Devices which require packaging, including labelling
- MDT 2012 Devices which require installation, refurbishment
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