Global certification, assurance, and risk management provider DNV is set to grow its medical device assurance capabilities through its acquisition of Germany-based notified body, MEDCERT.
Headquartered in Hamburg, MEDCERT is one of the largest notified bodies in Germany and is among the leading notified bodies under the EU regulations for medical devices. Since 1994, it has specialised in the auditing, certification and conformity assessment of quality management systems and medical devices, with operations spanning Europe, North America, and Asia.
The acquisition greatly increases DNV’s capacity to deliver additional notification services of medical devices globally. It will also increase DNV’s market share in the medical devices sector by adding a separate MDR notification, enabling it to leverage on differences in requirements and approach with increased flexibility, and will bring an additional hub in Germany.
The addition of more technical personnel will enable DNV to more strongly address the upcoming recertification peak expected as all MDD (medical devices directive) certificates must be replaced with MDR certificates prior to May 2024, ensuring European market access for manufacturers.
Luca Crisciotti, CEO – supply chain & product assurance at DNV, said: “Acquiring high performing companies like MEDCERT delivers on DNV’s strategy to grow our already strong position in the medical devices industry over the coming years, complementing our ambition for global growth across our assurance portfolio. Notified body services are in high demand so this combined offering enables DNV to deliver a more robust service in a more sustained way to our customers, offering an enhanced assurance portfolio to medical device manufacturers across the world. We look forward to realising this growth with the MEDCERT team onboard.”
Klaus-Dieter Ziel, managing director of MEDCERT, added: “We look forward to joining DNV and continuing to deliver exceptional services to customers together from a market-leading global platform. With the upcoming recertification deadline, we believe our combined offering will be able to meet the needs of any medical device manufacturing business seeking assurance services globally.”