Tuttlingen – As an interface between manufacturers of medical devices and their users, instructions for use are of central importance. This is reflected in strict regulatory requirements and just as many questions regarding practical, efficient and safe implementation - which will be the focus of a symposium on December 5th in Tuttlingen.
An instruction manual, as the European Medical Device Regulation (MDR) summarizes, “refers to information provided by the manufacturer in which the user is informed about the intended purpose and correct use of a product as well as any precautionary measures that may need to be taken.” A simple sentence behind it which hides a lot of effort. “It starts with understanding the formal requirements and implementing them correctly,” explains MedicalMountains Managing Director Julia Steckeler. However, the following also applies: “The instructions for use can be viewed as the manufacturer's 'business card'”, i.e. as an element to strengthen customer satisfaction and loyalty. Many companies were still looking for solutions to sensibly streamline the various aspects and internal implementation processes - which ultimately led to the decision to organize the symposium.
The program is based on the path that an “Instruction for Use”, or IFU for short, goes through at manufacturers. Writing, design and dealing with the diversity of languages are at the beginning; Christoph Kiesselbach (Schrack & Partner, Reutlingen) combines information on, among other things, relevant legal and normative requirements and required content with case studies and best practices. Jörg Stockhardt (consulting & more, Berlin) takes a look at the entire product life cycle - how everything works together when, for example, findings from after-market observation or risk management result in the need for changes to the documents. Michael Kania (meddevo, Fulda) examines the practical implementation of the IFU process and the associated pitfalls, focusing on the technical possibilities and digital tools depending on the size of the company.
Nevertheless, anyone who speaks of “instructions for use” in the EU usually means the paper form. The sole use of a purely electronic IFU, the eIFU, is reserved for only a very few product groups; for everyone else it remains a voluntary addition to the printed version. At least for now, Julia Steckeler discusses whether such a regulation is contemporary based on survey results. Franz Menean (MEDAGENT GmbH, Mühlheim) addresses the challenges of implementing eIFUs, particularly questions of validation.
“The symposium reflects a diverse topic in the truest sense and is intended to help people gain security and confidence with regard to instructions for use,” says Julia Steckeler, summarizing the aim of the day. In addition to providing information, this also includes dialogue: the last hour of the event is reserved for participants' questions to the experts - so that as many people as possible take away "instructions for use" on how these can best be implemented for medical technology.
- Further information about the symposium and registration can be found at this link .
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