Medical Device Registration dossier packages
In May 2021, the new Medical Device Regulation (MDR) replaced the former Medical Device Directive (MDD) in all countries within the European Union. Even when the principal mode of action is a drug, some containment systems are classified as a medical device part within a Single-Integral Drug Device Combination product (DDC). This classification applies in particular to prefillable syringes and cartridges which are not reusable. In this case, SCHOTT is classified as the “Manufacturer of a critical component of a medical device”. The final holder of the license of the DDC has to apply for a “Notified Body Option” to register the device part (e.g. prefillable syringe) as a medical device.
The General Safety and Performance Requirements (GSPRs) within the MDR require a much more detailed and comprehensive MDR dossier, which is finally assessed by a notified body. A notified body is accredited by a national competent authority and therefore has a role similar to that of a health authority.
SCHOTT Pharma helps customers prepare for the Notified Body Opinion by providing customized dossier packages that cover the device part at the expected level of detail.
SCHOTT Pharma: MDR dossiers for customers' NBO success
Annex I of the Medical Device Registration dossier packages must describe both the medical device part and the containment system, and include a detailed assessment of the GSPRs. This approach to content selection and documentation has been verified based on in-depth experience of interactions with several notified bodies.
Based on this content selection, SCHOTT Pharma can prepare dossier packages that are customized to your specific combination of application and containment system. These dossier packages comprise specifications, raw material compliance, system compliance, product risk reports, production site compliance, process validation, and batch certification.
Our regulatory team collaborates with a number of notified bodies. This enables the direct exchange of confidential details under NDA with notified bodies to support the success of Notified Body Opinion applications.
A single, complete dossier for Medical Device Registration
Medical Device Registration dossier: How to proceed
MDR dossier packages are specific to your combination of product and country of interest. SCHOTT Pharma’s experts are ready to compile these documentation packages upon request.