GSPR dossiers for MDR compliance Complete documentation to support a positive Notified Body opinion
Request MDR DossierThe pathway for registration in the EU
Annex 1 of the EU Medical Device Regulation (MDR) categorizes syringes and cartridges as part of a single integral product. The primary mode of action in single integral products is a pharmacological, immunological, or metabolic mechanism.
As a result, pharmaceutical companies are required to provide a positive Notified Body opinion (NBo) as part of their product registration in the EU. To receive a positive NBo, applicants have to submit detailed documentation in accordance with the General Safety and Performance Requirements (GSPRs).
SCHOTT Pharma helps customers prepare for the NBo by providing customized dossier packages that cover the device part with the required level of detail.
GSPR dossiers for NBo success
As per Annex I of the Medical Device Registration, the documentation required to receive a positive NBo must describe both the medical device part and the containment system, and include a detailed assessment of the product with respect to the relevant GSPRs.
SCHOTT Pharma supports pharmaceutical companies with a selection of content and documentation in a comprehensive, customized dossier package. Our approach has been proven through a large number of successful customer projects and interaction with several Notified Bodies.
Our regulatory team collaborates with a wide range of Notified Bodies. This enables the direct exchange of confidential details under NDA with Notified Bodies and the support of successful NBo applications.
The complete dossier approach
All in one – receive your documentation as a unified and comprehensive package
Direct contact – our regulatory expert team is always on your side in the event of urgent authority enquiries
Reliable partner – our best practices and proven track record ensure that dossiers match authority perspectives
Always up to date – we constantly monitor regulatory changes and assess their impact on registration requirements
GSPR dossiers: How to proceed
GSPR 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.
1. Request dossier package
Please use the online form to transfer your product details and other information to receive a proposal that includes timeline information.
2. Request additional documentation
If you need documentation that exceeds the GSPR dossier package’s content, please use the online form to receive a proposal that includes a timeline.
3. Receive dossier package
After acceptance of our proposal, our expert regulatory team will complete your documentation package via a secure data exchange link.
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