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.