Technical documentation is a core part of the process of approval of medical devices. Without this documentation, a manufacturer cannot perform the conformity assessment procedure with his medical device, thus, the product cannot be approved. Therefore, it is of great importance to maintain a technical documentation compliant with the standard. The new MDR adds further elements and requirements, which result in a notable extra effort for the technical documentation. Therefore, it is essential not to lose track with so many formalities.
Signification and definition
In general, the term technical documentation (short: TD) is a generic term for product documentation, which gives the evidence, that a medical device meets the general safety and performance requirements (MDR annex I), that is: the medical device conforms to the regulation. No matter the class of the medical device – a technical documentation must always be available. In particular, for the TD must comply with the requirements of the authorities in order to obtain CE conformity for their medical device. In addition to that, products of the class Is, Im, Ir need also comply in parts with the requirements of the notified body, products of the class IIa, IIb and III must comply completely.
In annex II and III, the MDR depicts precisely what every documentation must contain. In comparison, the MDD previously did not specify much in terms of content, now the MDR tightens the strings and does even go one step further, as it determines criteria for a TD for post-market surveillance.
Content according to MDR
The MDR clearly defines what elements need to be in a technical documentation:
- Device description and specification, including variants and accessories
1.1 Device description
c) patient population and their medical condition
d) principle of operation
e) rationale that the present product is a medical device
g) explanation of innovations
h) description of accessories and, if applicable, system components
k) raw materials and elements with human body contact
l) technical specifications
1.2 Reference to previous and similar generations of the device
- Information to be supplied by the manufacturer: device and packaging label and instructions for use
- Design and manufacturing information
- General safety and performance requirements (annex I)
- Benefit-risk analysis and risk management (annex I, section 1, 3, 8)
- Product verification and validation
6.1 Pre-clinical and clinical data
6.2 Additional information required in specific cases:
a) medicinal product as an integral part
b) tissues or cells of human or animal origin
c) combinations of substances for absorption, dispersion, metabolisation, excretion
d) justification for use of CMR-substances or endocrine-disrupting substances
e) information relevant for sterilisation
f) measuring function information
g) description of combination/configuration with connected devices
For implantable devices and class III devices (except for custom-made devices or investigational devices), the manufacturer must create a short report on safety and clinical performance (article 32).
The technical documentation on post-market surveillance (annex III) focuses on the following:
- Post-market surveillance plan
- Post-market surveillance report (class I), periodic safety update report PSUR (class IIa, IIb, III)
Although this short exposition above is already a summarised version, it clearly illustrates how the comprehensiveness and requirements of the technical documentation have increased.
An important fact is, that with the new MDR the EU Commission is able to change the requirements for the TD in accordance with technical progress, if necessary. In practical terms, this means: the technical documentation of every medical device must be continuously kept up to date.
Does the one technical documentation exist?
Unfortunately, this question has to be answered with a “no”. The MDR does provide guidelines as to which content must be present in a technical documentation for approval in the European area, however, it does not give explicit information in terms of the structure and uniformity of the documents. It only refers to a “clear, organised, readily searchable and unambiguous manner” (MDR annex II). Meaning that, eventually, every technical documentation has the same form of content, but as far as the general structure or the chapter structure is concerned, there may well be differences between individual authors. However, most authors of technical documentations as well as authorities or notified bodies often follow specifications in recognised standards/guidelines (state of the art). At this point it should be noted, that a uniform structure of the technical documentation (a kind of model) given by the MDR would certainly have its advantages for authorities as well as manufacturers.
A certain point of reference in terms of structure is the so-called STED (Summary Technical Documentation), which was created by the Global Harmonization Task Force (GHTF), the predecessor of today’s International Medical Device Regulators Forum (IMDRF). Its aim was to develop global unique applications for approval for medical devices. Currently, STED is recognised in the U.S., Europe, Canada, Australia and Japan.
Yet, for another reason there is not just the one technical documentation, for: different countries, different ... documentations. Outside the EU the MDR does not apply, thus other regulations do.
In the U.S., under the regulations of the FDA other document types are required in connection with the technical documentation: Device Master Record, Design History File and Device History Record. The DMR contains documents, which describe how a medical device is produced, operated and maintained. The DHF illustrates the complete development history of a product, whereas the DHR serves as an evidence that the medical device is produced according to the specifications in the DMR and that all essential criteria is fulfilled. This way, the documents also contribute to quality assurance. Only in conjunction, the DHF, DMR and DHR make every step of a medical device and its development and production process comprehensible. Therefore, the Device Master Record, the Design History File and the Device History Record are important components for drawing up a TD.
In Canada, the structure of a technical documentation is based on the STED structure. The Canadian authority has also published an own model for this purpose.
Always applicable: manufacturers must be precisely informed about the regulatory requirements related to the TD in the country, where they want to obtain approval for a medical device.
What else to consider
However, many requirements for the technical documentation by the MDR are already partly known from standards, such as DIN EN ISO 13485, DIN EN ISO 14971 or DIN EN 62366-1. Often these are already applied in the companies concerned. Thus, it is within the bounds of feasibility, under the MDR, to apply these requirements to TD. For the MDR does give the answer to one thing: the “person responsible for regulatory compliance” (article 15) is also responsible for drawing up the technical documentation and keeping it up to date.
It is one of our specialities to draw up a technical documentation and keep it up to date. We would kindly support you thereby – please contact us!
Please note that all data and listings do not have the claim of completeness, are without guarantee and serve the pure information.