The preparation and certification of a product design dossier is a requirement for medical device manufacturers seeking to meet the essential requirements of the European Union’s (EU’s) directives and regulations for active implantable medical devices (AIMDD), in-vitro diagnostic medical devices (IVDD), and medical devices (MDD). The review and certification of the design dossier by EU Notified Bodies and other regulatory officials typically occurs after a lengthy and expensive product design and development process. Therefore, it is essential that the design dossier fully and effectively addresses all of the technical and safety issues mandated under the applicable regulations.
A poorly developed design dossier, or a design dossier that fails to address all of the applicable regulatory issues, can result in a delay in the product approval process, or even a rejection of an application for medical device approval. Device manufacturers are well advised to have their design dossiers reviewed and certified by a reputable, independent third-party with extensive knowledge of applicable regulations and experience in assembling the technical documentation necessary for prompt and efficient regulatory review and approval.
TÜV SÜD Product Service is an EU Notified Body and can conduct detailed design dossier reviews and issue design examination certificates in accordance with all EU directives concerning medical devices. In addition, TÜV SÜD Product Service has a global staff of medical device experts, with over 400 international specialists located in major markets around the world. These specialists are supported by TÜV SÜD Product Service’s own clinical affairs and foreign affairs department, and a scientific advisory board comprised of scientists and physicians from the leading universities and healthcare centres.