Two First MDR Certificates Issued – Are Floodgates Open For Mass Certifications?
Two First MDR Certificates Issued – Are Floodgates Open For Mass Certifications?
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Two medical device manufacturers have been granted the first certificates under the EU’s new regulations that are coming into force next year. Medtech looks at whether this is a sign that the whole sector is going to be able to meet regulations.
Author: Informa Pharma Intelligence
Publisher: MedTech
- Description
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.
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