With more than 30 years of experience and a broad international presence, IMNB delivers reliable, efficient, and high-quality auditing and certification services, helping manufacturers achieve and maintain compliance for market access in Europe and beyond.
Intertek Medical Notified Body AB (IMNB AB) is a globally recognized Notified Body, officially designated as NB 2862, specializing in the certification of medical devices under the EU Medical Device Regulation (MDR 2017/745). Headquartered in Stockholm, Sweden, IMNB operates worldwide, providing expert support to manufacturers navigating the complex regulatory landscape for medical devices.
With more than 30 years of experience and a broad international presence, IMNB delivers reliable, efficient, and high-quality auditing and certification services, helping manufacturers achieve and maintain compliance for market access in Europe and beyond.
Notified Body Number: NB 2862
Designation Authority: Sweden
Official Database: NANDO
Last Updated: June 21, 2025
Organization Information
Legal Entity: Intertek Medical Notified Body AB
Address: Torshamnsgatan 43, Box 1103, SE-164 22 Kista, Sweden
Phone: +46 8 750 00 00
Email: IMNB@intertek.com
Website: www.intertek.se
Scope of Designation
Device Categories by Type
A. Active Devices
1. Active Non-Implantable Devices for Imaging, Monitoring and/or Diagnosis
| Device Code | Device Category | Conformity Assessment |
|---|---|---|
| MDA 0201 | Active non-implantable imaging devices utilising ionizing radiation | Annex IX(I), IX(II), XI(A) |
| MDA 0202 | Active non-implantable imaging devices utilising non-ionizing radiation | Annex IX(I), IX(II), XI(A) |
| MDA 0203 | Active non-implantable devices for monitoring of vital physiological parameters | Annex IX(I), IX(II), XI(A) |
| MDA 0204 | Other active non-implantable devices for monitoring and/or diagnosis | Annex IX(I), IX(II), XI(A) |
2. Active Non-Implantable Therapeutic Devices and General Active Non-Implantable Devices
| Device Code | Device Category | Conformity Assessment |
|---|---|---|
| MDA 0301 | Active non-implantable devices utilising ionizing radiation | Annex IX(I), IX(II), XI(A) |
| MDA 0302 | Active non-implantable devices utilising non-ionizing radiation | Annex IX(I), IX(II), XI(A) |
| MDA 0303 | Active non-implantable devices utilising hyperthermia/hypothermia | Annex IX(I), IX(II), XI(A) |
| MDA 0304 | Active non-implantable devices for shock-wave therapy (lithotripsy) | Annex IX(I), IX(II), XI(A) |
| MDA 0305 | Active non-implantable devices for stimulation or inhibition | Annex IX(I), IX(II), XI(A) |
| MDA 0306 | Active non-implantable devices for extra-corporal circulation, administration or removal of substances and haemapheresis | Annex IX(I), IX(II), XI(A) |
| MDA 0307 | Active non-implantable respiratory devices | Annex IX(I), IX(II), XI(A) |
| MDA 0308 | Active non-implantable devices for wound and skin care | Annex IX(I), IX(II), XI(A) |
| MDA 0309 | Active non-implantable ophthalmologic devices | Annex IX(I), IX(II), XI(A) |
| MDA 0310 | Active non-implantable devices for ear, nose and throat | Annex IX(I), IX(II), XI(A) |
| MDA 0311 | Active non-implantable dental devices | Annex IX(I), IX(II), XI(A) |
| MDA 0312 | Other active non-implantable surgical devices | Annex IX(I), IX(II), XI(A) |
| MDA 0313 | Active non-implantable prostheses, devices for rehabilitation and devices for patient positioning and transport | Annex IX(I), IX(II), XI(A) |
| MDA 0314 | Active non-implantable devices for processing and preservation of human cells, tissues or organs including in vitro fertilisation (IVF) and assisted reproductive technologies (ART) | Annex IX(I), IX(II), XI(A) |
| MDA 0315 | Software | Annex IX(I), IX(II), XI(A) |
| MDA 0316 | Medical gas supply systems and parts thereof | Annex IX(I), IX(II), XI(A) |
| MDA 0317 | Active non-implantable devices for cleaning, disinfection and sterilisation | Annex IX(I), IX(II), XI(A) |
| MDA 0318 | Other active non-implantable devices | Annex IX(I), IX(II), XI(A) |
B. Non-Active Devices
1. Non-Active Implants and Long Term Surgically Invasive Devices
| Device Code | Device Category | Conformity Assessment |
|---|---|---|
| MDN 1101 | Non-active cardiovascular, vascular and neurovascular implants | Annex IX(I), IX(II), XI(A) |
| MDN 1102 | Non-active osteo- and orthopaedic implants | Annex IX(I), IX(II), XI(A) |
| MDN 1103 | Non-active dental implants and dental materials | Annex IX(I), IX(II), XI(A) |
| MDN 1104 | Non-active soft tissue and other implants | Annex IX(I), IX(II), XI(A) |
2. Non-Active Non-Implantable Devices
| Device Code | Device Category | Conformity Assessment | Conditions/Limitations |
|---|---|---|---|
| MDN 1201 | Non-active non-implantable devices for anaesthesia, emergency and intensive care | Annex IX(I), IX(II), XI(A) | - |
| MDN 1202 | Non-active non-implantable devices for administration, channelling and removal of substances, including devices for dialysis | Annex IX(I), IX(II), XI(A) | - |
| MDN 1203 | Non-active non-implantable guide catheters, balloon catheters, guidewires, introducers, filters, and related tools | Annex IX(I), IX(II), XI(A) | - |
| MDN 1204 | Non-active non-implantable devices for wound and skin care | Annex IX(I), IX(II), XI(A) | - |
| MDN 1205 | Non-active non-implantable orthopaedic and rehabilitation devices | Annex IX(I), IX(II), XI(A) | - |
| MDN 1206 | Non-active non-implantable ophthalmologic devices | Annex IX(I), IX(II), XI(A) | - |
| MDN 1207 | Non-active non-implantable diagnostic devices | Annex IX(I), IX(II), XI(A) | - |
| MDN 1208 | Non-active non-implantable instruments | Annex IX(I), IX(II), XI(A) | - |
| MDN 1209 | Non-active non-implantable dental materials | Annex IX(I), IX(II), XI(A) | - |
| MDN 1210 | Non-active non-implantable devices used for contraception or prevention of the transmission of sexually transmitted diseases | Annex IX(I), IX(II), XI(A) | Restricted to condoms |
| MDN 1211 | Non-active non-implantable devices for disinfecting, cleaning and rinsing | Annex IX(I), IX(II), XI(A) | - |
| MDN 1212 | Non-active non-implantable devices for processing and preservation of human cells, tissue or organs including in vitro fertilisation (IVF) and assisted reproductive technologies (ART) | Annex IX(I), IX(II), XI(A) | - |
| MDN 1213 | Non-active non-implantable devices composed of substances to be introduced into the human body via a body orifice or the dermal route | Annex IX(I), IX(II), XI(A) | - |
| MDN 1214 | General non-active non-implantable devices used in health care and other non-active non-implantable devices | Annex IX(I), IX(II), XI(A) | - |
Horizontal Technical Competence
| Product Code | Product Category | Limitations |
|---|---|---|
| MDS 1001 | Devices incorporating medicinal substances | - |
| MDS 1002 | Devices manufactured utilising tissues or cells of human origin, or their derivatives | - |
| MDS 1003 | Devices manufactured utilising tissues or cells of animal origin, or their 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 | - |
| MDS 1005 | Devices in sterile condition | Including aseptic processing, ethylene oxide gas sterilisation (EtO, EOG), low temperature steam and formaldehyde sterilisation, moist heat sterilisation, radiation sterilisation (gamma, x-ray, electron beam), sterilisation with hydrogen peroxide, sterilisation with liquid chemical sterilising agents and thermic sterilisation with dry heat |
| 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 | - |
Manufacturing Technologies
| Technology Code | Technology Category | Limitations |
|---|---|---|
| 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 (e.g. textiles, rubber, leather, paper) | - |
| 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 2009 | Devices manufactured using processing of materials of human, animal, or microbial origin | - |
| 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 | - |
| MDT 2013 | Devices which have undergone reprocessing | Excluding reprocessing of single-use devices |
Scope Verification
The complete and up-to-date scope of designation can be verified through the official NANDO database maintained by the European Commission:
Website: https://webgate.ec.europa.eu/single-market-compliance-space/
Search Parameters: Notified Body 2862, Regulation (EU) 2017/745
Contact Information
For scope-related inquiries or to verify device coverage:
Email: IMNB@intertek.com
Phone: +46 8 750 00 00
Address: Intertek Medical Notified Body AB, Torshamnsgatan 43, Box 1103, SE-164 22 Kista, Sweden
This scope information is based on the official NANDO database and is subject to updates by the designating authority. Please verify current scope status through the official NANDO database for the most recent information.
