Classification, CE marking, technical documentation: We are the competent contact for all aspects of regulatory and market-related issues. Diapharm supports manufacturers of medical devices, combination products and in vitro diagnostic (IVD) medical devices, making their work easier. We are the professional contact for all questions that arise with regard to market requirements, medical devices directives and especially the new EU regulations on medical devices.
Regulation (EU) 2017/745 on Medical Devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVD) pose challenges to manufacturers of medical devices and IVDs. Substance-based medical devices, such as lozenges, dermatological products or nasal sprays which have a physical effect, are assigned to a higher risk class under the Medical Devices Regulation. As a result, certification is necessary to ensure their continued marketability. The introduction of classification rules also necessitates the involvement of a notified body for the vast majority of in vitro diagnostic medical devices. A quality management system in accordance with ISO 13485 is required in both cases.
We help manufacturers to effectively and efficiently meet the requirements of the Regulations on Medical Devices and IVDs.