Go ahead and peek! Technical documentation under the IVDR & MDR

Go ahead and peek! Technical documentation under the IVDR & MDR

Both EU regulations, IVDR 2017/746 and MDR 2017/45, which apply to in vitro diagnostics and medical devices respectively, specify the preparation of the technical documentation in accordance with Annexes II and III. However, in some cases, only together do they provide a coherent picture, which is why manufacturers are advised to: go ahead and peek!

Parallels in the requirements for technical documentation according to IVDR and MDR

In general, some key requirements for the documentation are the same in both regulations. First of all, Article 10 of each regulation stipulates the obligation to create technical documentation, maintain it and keep it for a period of at least 10 years after the last placing on the market:

• Manufacturers of devices […] shall draw up technical documentation for those devices and keep it up to date. The technical documentation shall be such as to allow the conformity of the device with the requirements of this Regulation to be assessed. The technical documentation shall include the elements set out in Annexes II and III.
• Manufacturers shall keep the technical documentation, the EU declaration of conformity and, if applicable, a copy of […] relevant certificates issued, including any amendments and supplements, available for the competent authorities for a period of at least ten years after the last device covered by the EU declaration of conformity has been placed on the market.

The specific contents are then listed in Annexes II and III of the Regulations.

• Annex II Technical documentation
• Annex III Technical documentation on post-market surveillance

In both regulations, Annex II contains the introductory words on the formal structure of the documentation. These are often overlooked or considered less important, but this should not be done lightly:

• The technical documentation to be drawn up by the manufacturer and, if applicable, its summary shall be presented in a clear, organised, readily searchable and unambiguous manner and shall include, in particular, the elements listed in this Annex.

The two guidance documents from Team NB, “Best Practice Guidance for the Submission of Technical Documentation under Annex II and III of MDR/IVDR”, i.e. the consensus of the notified bodies, further elaborate on this:

• Incomplete submissions – Insufficient or missing information not provided that is required for conformity assessment activities. This includes an incomplete or inconsistent description of the devices covered by the application and the related Technical Documentation (variants, accessories, combined devices covered by the Basic UDI-DI to be assessed).
• Lack of Cohesive Structure of Technical Documentation – The information is presented in the Technical Documentation but is difficult to locate.
• The submission should be accompanied by an index or table of contents with appropriate hyperlinks, as necessary, to aid navigation.
• The number of folders should be kept to a minimum and if possible, follow a logical flow per Annex II […].
• Ensure the data in the technical documentation is consistent with the data in the respective application forms.

The chapter structure at the top level of the MDR and IVDR is almost identical in the German version and identical in the English version.

So far, so good, but what are the differences between the regulations?

Differences between the contents of the technical documentation according to MDR & IVDR

The apparent first and biggest advantage of the technical documentation requirements in the IVDR is a clear expectation regarding the intended purpose. Manufacturers can see at a glance what is expected in terms of the content and structure of this key specification. Annex II provides the following details:

the intended purpose of the device; which may include information on:

1. i) what is to be detected and/or measured;

(ii) its function, such as screening, monitoring, diagnosis or aid to diagnosis, prognosis, prediction, companion diagnostic;

iii) the specific disorder, condition or risk factor of interest that it is intended to detect, define or differentiate;

1. iv) whether it is automated or not;
2. v) whether it is qualitative, semi-quantitative or quantitative;
3. vi) the type of specimen(s) required;

vii) where applicable, the testing population;

iii) the intended user;

1. ix) in addition, for companion diagnostics, the relevant target population and the associated medicinal product(s);

Even after lengthy discussions, the manufacturer of a medical device under the MDR may still be left in the dark as to how detailed the intended purpose should be and which aspects it should cover, particularly because individual aspects under the IVDR or in other legal areas outside the EU also specify the target population and the intended user, but this remains unclear for the MDR.

It is worth taking another look at the Team NB document, even if it does not provide a conclusive summary. However, it is clear that the indications should not be part of the intended purpose:

• The intended purpose or intended use should include enough details to enable ready understanding of the medical device per Article 2 (12).
• Pitfall: The intended purpose is vague or incomplete, and the documentation does not clearly differentiate between the intended purpose and the indications.
• Guidance: A clear, unambiguous and specific intended purpose which fulfills the definition in MDR Article 2 (12) must be provided.
• As the intended purpose is critical for accurately determining that the device is a medical device, and further the devices risk classification and the clinical data requirements, it is subject to scrutiny by the notified body and will be challenged if vague or incomplete.
• In the absence of a MDR definition, manufacturers are directed to MDCG 2020-6, which defines indications as “the clinical condition that is to be diagnosed, prevented, monitored, treated, alleviated, compensated for, replaced, modified or controlled”.
• In the absence of a MDR definition, manufacturers are directed to MDCG 2020-6, which defines indications as “the clinical condition that is to be diagnosed, prevented, monitored, treated, alleviated, compensated for, replaced, modified or controlled by the medical device”. It should be distinguished from “the intended purpose/intended use”, which describes the effect of a device.

However, one disadvantage of the requirements set out in Annex II, Chapter 1 of the IVDR is the lack of a list of indications, contraindications, warnings and technical specifications that are made available to users in instructions for use, etc. The indications and contraindications are only included in the performance evaluation in accordance with Annex XIII, but are certainly relevant for UDI assignment and the report in accordance with Article 29. The other content is only partially required directly in other places.

However, this information is certainly useful in view of the MDR in order to achieve a correct understanding of the product, especially among inspectors.

The Team NB relies on a description of the “key specifications” as part of the equivalence assessment:

• Provide an overview of identified similar devices available on the EU or international markets if such devices exist. Provide a comparison of the key specifications.

The issue of lack of consistency, particularly with regard to these aspects, is also explicitly addressed right at the outset:

• There are many areas of the technical documentation that will require the duplication of information for multiple documents such as device description. Please ensure that the information is correct throughout all areas where it is duplicated and consider the risk of potential errors/inconsistencies when updating (e.g. Basic UDI-DI, UDI-DI, intended purpose, indications for use, contraindications, warnings, etc.).

Chapter 3, ” Design and manufacturing information”, is more detailed in the IVDR when it comes to the design, i.e. the development phase of the products, but its content does not differ from Chapter 3 of the MDR. The “manufacturing information” is particularly interesting. While the MDR requires that “the data […] be included fully in the technical documentation“, the IVDR allows more leeway: “More detailed information shall be provided for the audit of the quality management system or other applicable conformity assessment procedures.” Similarly, the IVDR seems to be interested only in outsourced manufacturing activities, but not in outsourced design activities.

However, the Team NB takes a similar approach to the MDR and expects the following in this chapter

• The manufacturer shall include a detailed overview of the manufacturing processes and used technologies to enable understanding of the finished device. Manufacturing includes incoming inspection, production, assembly, packaging, sterile packaging, sterilisation and final packaging (as applicable). Indicate any special processes required to manufacture the device.

However, it remains the case that detailed information may only need to be provided during the audit and that information on non-critical suppliers/components does not need to be included in detail in the TD:

• More detailed information may always be provided for the audit of the quality management system or other applicable conformity assessment procedures. Reference can be made to the Device Master Record (DMR) and the quality plan of the devices covered in the document.
• For non-critical component suppliers (e.g. bulk), identification of the supplier only is required.

Chapter 6 naturally has a different focus in both regulations, as the basic idea behind the products differs and IVDs are mostly used in a laboratory environment rather than in a patient environment. These are the minimum topics required by Annex II that a manufacturer must address:

For these topics, it is definitely worth taking a look at the Team NB documents, not least because they address other issues such as the preparation of medical devices, metrological traceability of calibrator and control material values, and product life more clearly than the regulations do. Ultimately, it is difficult to ignore these topics. And it can also be helpful to look beyond the horizon at the other regulation.

Go ahead and peek! But do it right!

At first glance, these differences may seem annoying. And certainly, one can agree with this, especially since both regulations were developed in parallel.

At the same time, one can also make a virtue out of necessity and seek the best of both worlds.

Well, not just off the top of your head, of course; depending on the regulation, you should naturally stay within your own territory. But it is definitely worth taking a peek at the neighbouring regulation or even copying it.

When developing an intended purpose in accordance with the MDR, this may mean that one also considers the intended purpose in accordance with the IVDR.

An example: “The SPICK product is intended for the relief of pain after bone fractures. The active product is intended for use on the whole body by means of radiation in adult patients by professional users. Not for use as a heat lamp.”

When compiling the manufacturing and validation documentation in Chapter 3 of the TD for an MDR product, if not all the required documentation is received from suppliers or sub-suppliers, a (company) risk-based approach to selecting the necessary documentation can certainly be developed, taking into account the requirements of the IVDR. We would be happy to support you in developing such an approach on a product-specific and individual basis.

For IVDs, content such as contraindications or key specifications that are relevant to the user should also be defined at an early stage, as is the case with an MDR product. Technical details such as temperature and humidity during use or storage should not be hidden in the depths of a possible lifetime test for sensitive products such as in vitro diagnostic devices. One option is to expand “Chapter 1 Product Description and Specification” to include the following MDR sections:

• the intended patient group and the medical condition to be diagnosed, treated and/or monitored, as well as other considerations such as patient selection criteria, indications, contraindications and warnings;
• technical specifications such as the characteristics, dimensions and performance attributes of the device, as well as any variants/configurations and accessories that are typically included in the product specification made available to the user, for example in the form of brochures, catalogues and similar publications.

For an IVDR device that comes into contact with the patient (e.g. because the patient holds the device), it is also worth referring to the MDR requirements for reprocessing and service life. The NB team expects the following information and documents on the subject of reprocessing, for example:

• Latest reversion of instruction of reprocessing
• Processing parameters for cleaning and disinfection, if applicable.
• Bioburden data if cleaning and disinfection by the user is not possible/forseen.
• Residual tests, if applicable for the disinfectants used.
• Reference to the section of the risk management file related to (re)processing
• Reference to the data collected as part of post-market surveillance (PMS) related to reprocessing.
• If applicable, lifecycle test data including functional testing and biological evaluation under consideration of the end of lifecycle.

You have now learned a few tips for taking a peek, but still don’t feel confident enough about the content of your technical documentation? Or do you simply lack the time to do it? Talk to us. We are happy to support you with our experience and resources in the field of TD, whether according to MDR or IVDR.

Please note that all details and listings do not claim to be complete, are without guarantee and are for information purposes only.