August 2021
· 11 min read
Although the Regulation (EU) 2017/746 in In Vitro Diagnostic Medical Devices (IVDR) presents several challenges for manufacturers, the technical documentation requirements can seem daunting. These requirements, however, are foundational for nearly every aspect of the regulation.
Whether you are new to the EU market or preparing an existing device portfolio for the IVDR, think of technical documentation as a series of pre- and post-market needs. This approach breaks implementation into more manageable pieces, making the process feel less overwhelming.
By understanding the landscape and regulatory requirements which apply to your products, compliance with the new regulation becomes more methodical. Annexes II and III of the IVDR clearly provide the general requirements; however, you will need to reference additional annexes to ensure you have the details you need (e.g., Annex I for GSPRs, Annex VI for UDI, Annex XIII for performance evaluation).
You know better than anyone what and how you are manufacturing. This knowledge will help you identify which legacy products to bring forward under the IVDR. To define the product portfolio, you must also classify which devices should be placed on the market as IVD devices. The classification influences the content included in the technical file (refer to MDCG 2020-16 and 2019-11). With products identified, you can turn to the regulation to understand what the IVDR expects based on your products.
Even with a device already on the market, most devices must be placed on the market again as IVDR-compliant. It is essential to consider pre-market technical documentation requirements and expectations to ensure you address all necessary regulatory requirements. This section focuses on documentation demonstrating how the IVD device's design and manufacture support its intended use and clinical benefit.
Annex II guides you through the process and can help you navigate through your technical documentation:
Section of Annex II | Description | Recommendation |
---|---|---|
Section of Annex II
1
|
Description
Device description and specification, including variants and accessories
|
Recommendation
Photos of all components and formats are helpful additions.
|
Section of Annex II
1.2
|
Description
Reference to previous and similar generations of the device
|
Recommendation
This provides a history of your device lifecycle and helps the notified body understand how relevant evidence relates to the current device and claims.
|
Section of Annex II
2
|
Description
Information to be supplied by the manufacturer
|
Recommendation
Include all your labeling (including IFU) and any marketing material that makes claims. Claims need to be supported by evidence. See Article 7 of the IVDR.
|
Section of Annex II
3
|
Description
Design and manufacturing information
|
Recommendation
Implementing processes according to IVDR and EN ISO 13485
|
Section of Annex II
3.1
|
Description
Design information
|
Recommendation
Notified bodies need all details relevant for a basic understanding of design and manufacture. Risk management should be carried out according to EN ISO 14971.
|
Section of Annex II
3.2
|
Description
Manufacturing information
|
Recommendation
Don't forget to include full details of critical suppliers and subcontractors, as the notified body may decide to audit them, as well.
|
Section of Annex II
4
|
Description
General safety and performance requirements (GSPRs)
|
Recommendation
Demonstrating compliance is about more than presenting a report. You must show why the evidence is relevant for each GSPR. See Annex I of the IVDR.
|
Section of Annex II
5
|
Description
Benefit-risk analysis and risk management
|
Recommendation
These should be "living" documents, showing the efforts to continually understand and mitigate risks while ensuring the device remains in compliance.
|
Section of Annex II
6
|
Description
Product verification and validation
|
Recommendation
Implementing processes according to IVDR and EN ISO 13485
|
Section of Annex II
6.1
|
Description
Information on analytical performance of the device
|
Recommendation
Ensure you have performance study reports and evaluations in the technical file that clarify how the results of analytical studies support the intended use.
|
Section of Annex II
6.2
|
Description
Information on clinical performance and clinical evidence (performance evaluation report)
|
Recommendation
The performance evaluation report (PER) provides evidence on scientific validity, analytical performance and clinical performance to demonstrate a favorable risk-benefit of the device.
|
Section of Annex II
6.3
|
Description
Stability (excluding specimen stability)
|
Recommendation
Accelerated data is insufficient to support claims.
|
Section of Annex II
6.4
|
Description
Software verification and validation
|
Recommendation
Refer to the IMDRF TOC, 2020-1 and IEC 62304 for comprehensive information on what is expected to be submitted1.
|
Section of Annex II
6.5
|
Description
Additional information required in specific cases
|
Recommendation
Refer to the details in the Annex to see if this applies.
|
Section of Annex II
7
|
Description
Declaration of conformity
|
Recommendation
Ensure your declaration of conformity (DoC) fulfills the requirements of Article 17.
|
As well as having your pre-market documents in order, you must document whether your surveillance mechanisms meet IVDR requirements and whether your plan is relevant to the device’s risk. Equally as important is the clarity of your post-market surveillance (PMS) plan. This document must be suitable for an external audience and clearly organized to prevent ambiguity.
Although device class dictates certain reporting elements of your PMS, your efforts must balance reactivity with proactivity, which distinguishes IVDR from many other regulations.
Remember to produce your technical documentation in a clear, organized, readily searchable and unambiguous manner and address all the elements listed in Annexes II and III. These steps should clarify what is needed in your technical documentation to place IVD devices on the market under the IVDR.
NSF helps you navigate the process, from training and preparation of your technical files to consulting, technical file remediation, performance evaluation reports, and more.
Source
1www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-190321-ivd-mdma-toc-n13.pdf