RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

Regulatory Focus™ > News Articles > 2020 > 5 > Swedish notified body is 14th designated under MDR

Swedish notified body is 14th designated under MDR

Posted 15 May 2020 | By Michael Mezher 

Swedish notified body is 14th designated under MDR

Sweden’s Intertek Medical Notified Body AB on Friday became the 14th notified body designated under the EU Medical Devices Regulation (MDR).
The newly designated notified body is the fifth to be designated in 2020, following the designation of German notified body mdc medical device certification GmbH last month, and the first to be designated in Sweden. (RELATED: German notified body is 13th designated under MDR as MHRA plots delay guidance, Regulatory Focus 27 April 2020).
With the date of application for MDR now delayed until 26 May 2021, it is possible that more notified bodies will be designated before the regulations take effect. (RELATED: Notified Bodies Prep for Post-May Designations, Regulatory Focus 11 February 2020).
“We are honoured to receive the MDR designation from the Swedish Competent Authority. Interket aims to provide total quality assurance to all its clients, and this designation brings us into the future of medical device audits,” said Calin Moldovean, president of business assurance and food services at Intertek.
With its designation, Intertek is certified to conduct conformity assessments for a range of active non-implantable devices and non-active devices. Intertek was not previously designated under the Active Implantable Medical Devices Directive and has not been designated to conduct conformity assessments of active implantable devices under MDR.
EC, Press Release

Regulatory Focus newsletters

All the biggest regulatory news and happenings.