The regulation on medical devices 2017/745, widely known as the EU MDR, was released in May 2017 with regulation 2017/746 on in vitro diagnostics. EU MDR and regulation 2017/746 replaced Council Directive 93/42/EEC, also known as the Medical Device Directive (MDD), and Directive 98/79/EC on in vitro diagnostic medical devices.
The EU MDR is a significant legislation that oversees safety, quality and traceability. It ensures sound clinical evidence, transparency and accountability of legal manufacturers towards users and patients. Due to its complexity and timelines, this legislation has been widely criticised and feared, notably from start-ups and small medical device companies concerned about their future and ability to succeed. All manufacturers who trade in the EU must comply with these new and far-reaching MDR requirements.
The new EU MDR regulation was published in the Official Journal of the European Union on May 5, 2017, and entered into force on May 26, 2021 and can be implemented by manufacturers with immediate effect. The European Commission set a transition timeline of three years during which medical device manufacturers can update their product documentation, as required. In addition, there are several other deadlines that manufacturers must meet during this timeframe.
The first timeline of the EU Database for Medical Devices (EUDAMED) went live in 2020. Datasets and files to be provided for EUDAMED registration include content that must correspond with the product documentation and the Instructions for Use (IFU), such as proper trade names, product descriptions, storage and handling conditions, critical warnings, contraindications, information regarding sterilisation and reprocessing, listing substances, etc.
In May 2022, certificates of conformity that were previously issued under the MDD will expire and new certifications under the MDR rules will require manufacturers to have MDR-conforming labelling as a part of their technical documentation.
Labelling requirements
Annex I Chapter III of the MDR summarises the requirements for labelling, including the IFU. The MDR requirements on user and patient labelling are highly user-centred. IFUs must not only be safe and transparent, but it is essential they are also clear and understandable.
Risks, limitations, contraindications, precautions, warnings and special storage conditions are required to be communicated to the user immediately upon first contact with the packed device – which means directly on the label and prior to unpacking. In cases where directions are too voluminous for a device label, they need to be completely and properly explained in the IFU. For example, the MDR, compared to the former MDD, requires more stringent instructions on how to declare and handle sterile packaging. These instructions require additional clearly explained directions in the IFU.
Graphical symbols
The use of harmonised and internationally recognised symbols is another labelling-related MDR requirement that primarily corresponds with ISO requirements. IFU-related updates of explanations of graphical symbols must be made, if not made already.
It is advantageous for manufacturers that the regulation does not require a description for each graphical symbol on the label, as this in fact saves space. However, the use of symbols without explanation appears to be in contradiction with another MDR requirement that states user documentation must be easily understandable. While a healthcare professional may understand the meaning of such symbols, the patient may not. Therefore, the MDR requires that symbols be explained in the IFU and this may mean the IFU must be updated. The fact that the information in labelling must be readily understood by the intended user is emphasised in several sections of the MDR and manufacturers are encouraged to improve their instructions with drawings and diagrams.
In conclusion, the IFU updates appear to be highly complex. Such complexity is expected to be a source of frequent errors during the implementation process. On one hand, there will be updates of data, names, descriptions and points of contact. On the other hand, wording needs to be revised carefully to provide clear and exhaustive information that accurately corresponds with clinical data. All this information must be understandable to the healthcare professional as well as the non-expert user and patient. Adding to the complexity will be periodic updates from clinical trials—in addition to reports and observations from post-market surveillance—that will necessitate systematic and thorough update approaches throughout the product lifecycle.
Using an automated proofreading solution could help ensure that documents have been completely and accurately updated. Using a proofreading solution will also assist in reducing time spent reviewing the often large and complex IFU updates.
A step in the right direction
The MDR updates represent a step towards high standards. At the same time they create challenges and the need for additional resources. The IFUs should be flawless, not only because they need to comply with the regulation and to avoid legal liabilities, but above all, to ensure optimal use of the medical device.
Lastly, IFUs that are up to date, well-structured and easily understood are not only important from a scientific perspective but are also valuable from a marketing perspective. IFUs that are not easily understood or that lead to incorrect usage negatively impact sales. A medical device that is not easy to use because of a suboptimal IFU is also not an easy sell.
How to ensure accuracy during the IFU update process
Once you have updated your IFU to comply with the MDR requirements, you will still need several verifications and comparisons to successfully exit the labyrinth of updates, deletions and additions in order to finalise your documents.
Due to the nature of these updates, there can be several types of possible errors, including spelling mistakes, repetitions and omissions plus discrepancies in crucial data, addresses and emergency phone numbers.
At this point, a reliable proofreading software can prove to be invaluable. Schlafender Hase’s TVT (Text Verification Tool®) will help you identify these mistakes very quickly and create consistency among document sections, sets of documents, sets of labelling items or among entire product groups. TVT is a text and graphic software that ensures only approved content is printed or published.
Any manufacturer is aware of the consequences of labelling errors, this is especially true in the medical device and pharmaceutical industries. Labelling errors are not just a threat to patient health – they can also lead to Corrective and Preventive Actions (CAPAs) and costly reprints or even recalls that ultimately damage a company’s reputation and financial performance.
As medical device companies make their labelling (including IFUs) publicly available on their websites, the importance of clear and precise labelling will increase. With the upcoming MDR requirements, the ability to produce error-free labelling will increasingly become a competitive advantage for every medical device and pharmaceutical company.
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