Following on from being the first EU notified body in the world to achieve designation to the Medical Devices Regulation, BSI was informed on 6 November by the Dutch Ministry of Health (VWS) that it’s Netherlands notified body is also now designated to the new MDR (EU 2017/745)1.
BSI will now be able to provide conformity assessments to the full scope of the MDR from both its UK and Netherlands notified bodies. The designation scope includes:
- Active implantable devices
- Active non-implantable devices for imaging, monitoring and/or diagnosis
- Active non-implantable therapeutic devices and general active non-implantable devices
- Non-active implants and long term surgically invasive devices
- Non-active non-implantable devices
The scope of BSI’s designations also covers new categories of devices with specific characteristics that were introduced under MDR such as:
- Devices manufactured utilising tissues or cells of human origin or their derivatives
- Reusable surgical instruments
- Devices incorporating or consisting of nanomaterials
- Devices locally dispersed in the human body or intended to undergo a chemical change in the body
- Custom-made class III implantable devices
- Devices without an intended medical purpose as per Annex XVI of the Regulation (conditional on Common Specifications being published)
For further details on BSI’s scope, please visit the NANDO information system.
Manuela Gazzard, Group Director of Regulatory Services at BSI commented: “We were the world’s first notified body (0086) to be designated to the MDR, the first to issue an MDR certificate and we’re delighted to achieve our second MDR designation in Netherlands (2797). Over the past two years, we’ve invested heavily in growing and training our people to be able to deliver MDR conformity assessments at this critical time for the industry.”
Gary Slack, Senior Vice-President of the notified body at BSI, said: “Pressure is building in the industry to meet the MDR deadline and this full scope designation in the Netherlands will ensure that we can continue to meet industry demand and ensure patients get access to safe innovative new technology. The fact that BSI now has two out of the seven MDR notified body designations highlights our market leading position and is testament to the expertise of our people.”
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Notes to Editors:
1This regulation was published on 5 May 2017 and manufacturers will need to start complying with it by the 26 May 2020 in order to be able to place their devices on the market within the European Economic Area.