Oliver Hartmann

Oliver Hartmann is Legal and Regulatory Affairs Manager, AESGP, Belgium. 

  • nasal spray

    Substance-based medical devices: regulatory challenges and prospects


    Substance-based medical devices comprise a diverse group of products that are regulated under the Medical Devices Regulation, which is applicable since 26 May 2021. Compared with the previous legal framework, the MDR has introduced several extensive changes to the regulatory framework for medical devices that also impact on the marketing of substance-based medical devices in the EU…