Technical documentation is an important core element in the process of medical device approval. Without it, a manufacturer cannot carry out the conformity assessment with his medical device and thus the product cannot be approved. Therefore, it is of utmost importance to maintain standard-compliant technical documentation. Under the new MDR, additional components and requirements have now been added, resulting in a significant increase in the amount of work involved in technical documentation. With so many formalities, it is therefore essential to maintain an overview.
Definition and delimitation of terms
In general, technical documentation (TD) is the generic term for product documentation that provides evidence that the essential safety and performance requirements (in Annex I of the MDR) for a medical device have been met, i.e. that the medical device complies with the regulation. This is independent of the class of the medical device – technical documentation must always be available. Especially since the TD must also meet the requirements of the authorities in order to obtain CE conformity for the medical device. For class Is, Im, Ir devices, there is the additional requirement that the TD must at least partially comply with the requirements of the Notified Body, and for class IIa, IIb and III devices, it must fully comply.
The MDR describes in Annex II and III specifically what must be included in any documentation. Whereas previously the MDD specified comparatively little in terms of content, the MDR now tightens up and even goes a step further by specifying criteria for a TD on post-market surveillance.
Content according to the MDR
The MDR clearly defines which components must be present in the technical documentation:
Product description and specification, including variants and accessories.
1.1 Product description
c) patient group and their disease state
d) Mode of operation
e) justification that this device is a medical device
g) Explanation of innovations
h) description of accessories and, if applicable, system components
j) constituent parts/components
k) raw materials and substances with body contact
l) technical specifications
1.2 Reference to previous and similar generations of the product
Information to be provided by the manufacturer: Product/packaging labeling and instructions for use Information on design and manufacture.
Information on design and manufacture
Essential performance and safety requirements (according to Annex I)
Benefit-risk analysis and risk management (according to Annex I, section 1, 3, 8)
Verification and validation
6.1 Preclinical and clinical data
6.2 Additional information required in specific cases:
(a) Medicinal product as an ingredient
b) Tissues or cells of human or animal origin
c) substance combinations for absorption, distribution, metabolism, excretion
d) justification in case of use of CMR substances or substances with endocrine effects
e) Sterility-relevant information
f) Information relevant to measurement function
g) Interface/configuration description for connected devices
For implantable devices and Class III devices (other than custom-made or investigational devices), the manufacturer must prepare a summary report on safety and clinical performance (Article 32).
The technical documentation on post-market surveillance (Annex III) focuses its attention on the following:
Post-market surveillance plan
Post-market surveillance report (Class I), periodically updated safety report, including PSUR (Class IIa, IIb, III).
Although the above is already a summarized version, it still clearly represents how much the scope of technical documentation and the requirements for it have increased.
An important point is that with the new MDR there is the possibility for the EU Commission to be able to change the TD requirements in line with technical progress if it becomes necessary. Conversely, this means that the technical documentation of any medical device must be continuously kept up to date.
Is there such a thing as technical documentation?
Unfortunately, this question must be answered with a “No”. Although the MDR specifies which contents must be present in the technical documentation for an authorization in the European area, the MDR does not provide any direct information on the structure and uniformity of the documents. It only speaks of a “clear, organized, easily searchable and unambiguous form” (MDR Annex II). This means that, in the end, every technical documentation produced will have the same content, but as far as general organization or chapter structure is concerned, there may well be differences between individual authors. However, most authors of technical documentation, and also the authorities or notified bodies, often adhere to the information contained in recognized standards/guidelines (state of the art). It should be noted at this point that a uniform structure in the structure of the technical documentation (a kind of model) provided by the MDR would certainly have its advantages for authorities and manufacturers.
A certain reference point as a structural model is the so-called STED (Summary Technical Documentation), which was initiated by the Global Harmonization Task Force (GHTF), the predecessor of today’s International Medical Device Regulators Forum (IMDRF). The goal was to create globally harmonized regulatory submissions for medical devices. Currently, STED is recognized by the USA, Europe, Canada, Australia and Japan.
But there is another reason why there is not just one technical documentation, because: other countries, other… documentation. Outside the EU, where the MDR no longer applies, different rules naturally apply.
In the U.S., under FDA regulations, certain types of documents are required in connection with technical documentation: device master record, design history file, and device history record. The DMR contains documents that describe how the medical device is produced, handled and maintained. The DHF shows the complete development history of a product, whereas the DHR is considered proof that the medical device has been produced according to the specifications stated in the DMR and meets all important criteria. In this way, the documents also contribute to quality assurance at the same time. Only in combination do the DHF, DMR and DHR make every step of a medical device and its development and production process traceable. To create a TD, the Device Master Record, the Design History File and the Device History Record are therefore important components.
In Canada, the structure of the technical documentation is based on the STED structure, for which the Canadian authority has also published a kind of model of its own.
As always, as a manufacturer, you need to find out exactly what the regulatory requirements are for TD in the country where you want to approve the medical device.
What else to keep in mind
However, many of the requirements for technical documentation imposed by the MDR are already partly known from standards such as DIN EN ISO 13485, DIN EN ISO 14971 or DIN EN 62366-1, which are often already applied in the company concerned. Thus, it is within the bounds of feasibility to transfer these requirements to the TD under the MDR. Because the MDR also answers one thing: The “person responsible for regulatory compliance” (Article 15) is also responsible for creating and updating the technical documentation.
The creation or updating of the technical documentation is one of our specialties, where we are happy to support you – contact us!
Please note that all details and listings do not claim to be complete, are without guarantee and are for information purposes only.