BSI UK and TÜV SÜD, two of the EU’s largest medtech notified bodies, have both certified products under new Medical Device Regulation rules. BSI UK rolled out certificates for Novartis’ Concept1 inhaler and TÜV SÜD has certified Biotronik’s Renamic programmer software. Biotronik also obtained MDR certification for its quality management system following successful conformity assessment. Medtronic looks at the timing of these two certifications from designation to certification and what the certifications by these two bodies signals for certification by the two other notified bodies in Italy and Germany.