BSI was informed on 21 January 2019 by the Medicines and Healthcare products Regulatory Agency (MHRA) that its UK notified body is the first in Europe to be designated to the new MDR (EU 2017/745).
This new 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. The challenge, until now, has been that no notified body was approved to undertake conformity assessments under the new, more stringent, legislation.
BSI will now be able to provide conformity assessments to the full scope of the MDR. 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 designation 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 are delighted to achieve our MDR designation ahead of our anticipated timeline and be the first to achieve it. Over the past two years, we’ve been expanding and training our people to be able to deliver MDR conformity assessments and with just over a year to go until the May 2020 deadline; this designation should help manufacturers to start the transitional process.”
Gary Slack, Senior Vice-President of the notified body at BSI, said: “Being the first notified body designated to the MDR is testament to the hard work, dedication, skills and expertise of our people. Our application for MDR designation under BSI’s new Notified Body in the Netherlands (2797) is progressing positively, and we will share further details once we have specific news. We are aware of the uncertainty created by Brexit, further details can be found on our dedicated webpage.”