Medical devices have to meet strict regulatory requirements to ensure their safety and performance. In Vitro Diagnostic (IVD) medical devices are no exception, and their manufacturers must demonstrate conformity to General Safety and Performance Requirements (GSPR) through technical documentation.
To ensure a unified approach to technical documentation submissions, Team NB members reviewed best practice guidance documents submitted by individual notified body members. The result is a comprehensive guidance document aligned with the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746.
Technical Documentation Submission
Manufacturers of all classes of IVD medical devices must prepare technical documentation that demonstrates conformity to GSPRs. The technical documentation must reflect the current status of the IVD medical device through application of the manufacturer’s Quality Management System (QMS). It must be prepared in a language acceptable to the reviewing organization, whether it be a notified body or regulatory authority.
The technical documentation reflects the status of the IVD medical device at a particular moment in time, such as the moment of premarket submission or when requested for post-market purposes.
MDx CRO can help you prepare high-quality technical documentation that meets the expectations of Notified Bodies and ensures compliance with the IVDR
Highlights of Team-NB guidance
Team-NB is an organization dedicated to promoting transparency and harmonization among notified bodies in Europe, which is a fundamental aspect for the development and certification of medical devices. You can see in their member page which Notified Bodies are part of Team-NB. The largest Notified Bodies are all represented.
The group supports the implementation of new regulations and provide guidance documents to ensure all members are meeting the same high standards of quality and compliance – essentially ensuring there is a level playing field when it comes to Notified Body expectations for compliance.
Key points to consider in your submission
Incomplete submissions and lack of cohesive structure of technical documentation are the most common reasons for delays in technical documentation reviews by notified bodies. To avoid delays and improve submissions, manufacturers should consider the following practical points:
- Communication with the notified body before an application is lodged: Manufacturers should clarify the language requirements, documentation labelling requirements, and submission methods with their notified body. General administrative information about the manufacturer should be provided in the technical documentation, including legal manufacturer name and address, EU Authorized Representative, and subcontractors’ location, EMDN coding, NANDO coding, and whether the device is made available to the market through distance sales.
- Technical documentation submission: The technical documentation must be presented in a clear, organized, readily searchable, and unambiguous manner. It must include regulatory references to the applicable regulatory requirements of the EU IVDR.
- The most recently updated comprehensive reports (including clinical performance studies) and data should be included. Abbreviated or partial test reports are not considered acceptable. Verification reports should be complete.
- The technical documentation must document how the manufacturer ensures compliance with every applicable GSPR. Information duplication for multiple documents, such as device description, should be correct throughout all areas where this information is duplicated.
- The data in the technical documentation must be consistent with the data provided in the respective application forms. Valid justifications should always be provided or accompanied where there are deficiencies in the requested data.
- As part of the technical documentation referred to in Annex II, the manufacturer shall keep up to date a list of all Unique Device Identifiers (UDIs) assigned.
If you're still undecided on which Notified Body to choose or you're in the early stages of development, this best practice guidance by Team-NB is a must-read!
Technical documentation submissions for IVD medical devices must demonstrate conformity to GSPR through clear and concise documentation of development, design, and manufacturing processes. Manufacturers should communicate with their notified body before submitting their technical documentation and ensure that it is presented in a clear, organized, readily searchable, and unambiguous manner.
They should provide comprehensive reports and data, document compliance with every applicable GSPR, and ensure data consistency throughout the technical documentation. By following these best practice guidance, manufacturers can streamline the technical documentation review process and expedite their IVD medical device’s regulatory approval and ensure that their technical documentation meets the regulatory requirements of the IVDR, regardless of which NB they eventually choose.
However, if a manufacturer has already selected a Notified Body, it is important to remember that each NB will have their own specific guidance and nuances that need to be taken into account when preparing technical documentation. Nonetheless, this guidance document is a great starting point and can help manufacturers ensure that their technical documentation is of a high standard, regardless of which NB they choose.
How can MDx CRO help?
MDx is a Medical Device & IVD Contract Research Organization (CRO) that can help IVD device manufacturers with the preparation of a complete set of technical documentation including:
- Risk Management documentation
- Design & Manufacturing documentation
- Device Description and Intended Purpose reviews
- Labelling and information supplied with the device
- General Safety & Performance Requirements (GSPR) checklists
- Clinical Evidence: Performance Evaluation Plan (PEP), Scientific Validity Report (SVR), Analytical Performance Report (APR), Clinical Performance Report (CPR), Performance Evaluation Report (PER),
- Post Market Surveillance (PMS) documentation, including PMPF, PMS reports and Periodic Safety Update Reports (PSURs)
- Summary of Safety and Performance (SSP) for classes C and D IVDs
- Declaration of Conformity (DoC)
- and more…
MDx has extensive experience in preparing IVDR technical documentation that meets Notified Body expectations. We work closely with our clients to ensure that their technical documents are designed and written in compliance with applicable regulations and guidelines.
Contact MDx CRO and start preparing IVDR compliant, high-quality technical documentation that meets Notified Body expectations!