Technical documentation for medical products

eDok is the specialist medical technology service provider within the kothes Group. The team contributes regulatory and authoring experience in the field of medical devices. Customers can combine this spec­ial­is­ation with kothes' broad range of services, such as technical writing, translation, systems consulting and digital information delivery. Medical technology enquiries are jointly assessed and handed over to the appropriate specialists within the group.

The technical docum­ent­ation for a medical device is the manuf­act­urer's compreh­ensive set of evidence. It describes the product and its intended purpose and includes, among other things, documents on development, risk management, verif­ic­ation, validation and post-market surv­eill­ance. By contrast, the instruct­ions for use provide users with information supplied with the product. They explain its intended use and provide the necessary safety and handling information. The instruct­ions for use form part of a medical device’s technical docum­ent­ation.

The specific requir­em­ents depend on the product, its intended purpose, risk class, target group and the intended markets. The MDR contains basic requir­em­ents for the information supplied with the product, in particular in Annex I, Chapter III. Depending on the product, these include, for example, information on ident­if­ic­ation, intended purpose, safe use, install­ation, maintenance, preparation, contraind­ic­at­ions and residual risks. In addition, product-specific standards and national language requir­em­ents may be relevant.

The instruct­ions for use are part of risk control. Risks that cannot be adequately controlled by design or technical measures must be addressed in an appropriate form in the instruct­ions for use. Warnings and safety instruct­ions should therefore be derived from the risk management process. Conversely, new findings from development, usability, complaints or market observation must be assessed to see whether the instruct­ions for use need to be adapted. General warnings without a specific reference are not a substitute for a coordinated risk assessment.

The risk class influences the conformity assessment procedure and the extent to which a notified body is involved. However, the basic obligation to have compreh­ens­ible technical docum­ent­ation applies to all medical devices. The specific evidence, assessments and information accomp­anying the product that are required do not depend solely on the class. The intended purpose, product char­act­er­istics, duration of use, invas­iv­eness and other class­if­ic­ation char­act­er­istics also play a role.

In the case of software as a medical device, in addition to the intended purpose and risk class­if­ic­ation, the software archit­ecture, development life cycle, verif­ic­ation, validation and relevant risks must also be documented in a traceable manner. Changes to functions, the user interface or algorithms can have an impact on risk management, usability and instruct­ions for use. It is also crucial that the valid docum­ent­ation can be clearly assigned to the respective software version. Which standards and evidence are to be applied depends on the specific software and its medical function.

An update may be necessary if the intended purpose, functions, operating procedures, safety information, software versions or regulatory requir­em­ents change. Insights from complaints, vigilance, market observation and post-market surv­eill­ance can also trigger adjustments. Before making a change, it should be checked which documents, labels, language versions and products already delivered are affected. The approval and validity of the new version must be regulated in a transparent manner.

The languages required depend on the markets in which the product is made available and on the respective national requir­em­ents. Technical terms, warnings, symbols and the intended purpose must remain consistent across all language versions. Approved terminology, qualified translation processes and documented checks are important for this purpose. If content is changed, it must also be clear which language versions are affected and need to be approved again.

Electronic instruct­ions for use are possible for certain medical devices and under specified conditions. In addition to the MDR or IVDR, the applicable spec­if­ic­at­ions for electronic directions for use are part­ic­ul­arly relevant. Manuf­act­urers must first check whether electronic provision is even permissible for the product and its intended users. Access, avail­ab­ility, version status, data protection and the possibility of a printed version must also be taken into account.