BSI’s Dutch Notified Body is Latest to be Designated Under MDR

Regulatory NewsRegulatory News | 06 November 2019 |  By 

The notified body designations under the incoming Medical Devices Regulation (MDR) are starting to pile up, with the announcement Wednesday of BSI’s Amsterdam-based notified body being designated, according to the European Commission.

BSI, which is the second NB in the Netherlands to be designated (the first was announced yesterday), said in a statement that it was informed on Wednesday by the Dutch Ministry of Health of the designation.

“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 company said. 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 and non-active non-implantable devices.

Gary Slack, SVP 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 other five NBs to be designated are: Germany’s TÜV Rheinland, Italy-based IMQ IstitutoBSI UK, Germany-based TÜV SÜD and Germany-based Dekra Certification GmbH.

The designations, which have been announced at a steady rate since the beginning of the year, come as device experts have warned of a pending shortage of NBs to certify devices, even if the Commission designates 20 notified bodies by next May, which is when MDR takes effect.



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