E-news: 02 September 2019
Novartis Concept1 inhaler receives world’s first MDR conformity certificate
BSI, today announces that it has certified the first product, the Novartis Concept1 inhaler, to the medical devices regulation (EU 2017/745) via its UK notified body (0086).
The Novartis Concept1 inhaler is classified as a IIa device under Rule 20 for the MDR. Prior to the new more stringent legislation coming into force, the inhaler was classified as a Class I device and did not need to be reviewed by a notified body.
Manuela Gazzard, Group Director of Regulatory Services at BSI said: “We are delighted to be issuing the world’s first conformity certificate under the new MDR to Novartis."
Gary Slack, Senior Vice-President of the notified body at BSI added: “Being the first to achieve designation and now the first to deliver a conformity assessment under the new Regulation is evidence of the hard work, dedication, skills and expertise of our people. The transition to the MDR is a significant challenge to the medical device industry as a whole. The increased requirements on manufacturers and notified bodies means the BSI team is experiencing increased pressure to meet the new regulatory assessments, however, the team have shown an extraordinary resilience and dedication. We continue to work towards certifying more devices under the MDR to the tight timelines outlined in the Regulation.”