Story How the industry can get to grips with the MDR The virtual MedtecLIVE & SUMMIT is the leading gathering of the European medical technology community in the first half of the year. The event will take place from 20 to 22 April, a good month before the European Medical Device Regulation (MDR) becomes binding on 26 May 2021. Regulatory affairs will therefore be a major topic of discussion in the MedtecSUMMIT congress programme. In addition, numerous exhibitors at MedtecLIVE will be offering advice and services relating to the MDR and other regulatory standards. Visitors to the second virtual edition of MedtecLIVE & SUMMIT can also look forward to making contacts and getting information on many other topical issues like wearables and additive manufacturing. With its second virtual round, MedtecLIVE & SUMMIT is again offering the industry a highly professional platform for discussing future trends in medical technology. “The major success of the first virtual edition of MedtecLIVE in the summer of 2020 reinforced our belief that such an innovative and digitally savvy sector like medical technology can benefit substantially from a virtual event,” says Christopher Boss, Director of MedtecLIVE at NürnbergMesse. “This is why for 2021 we have made our virtual MedtecLIVE & SUMMIT even more interactive and user-friendly and are taking the concept of ‘virtual networking’ to a new level with our specially designed studio and TV-quality live moderation!” MDR: tips, progress reports, solution providers In keeping with the theme “Don’t hesitate, innovate”, a session at the MedtecSUMMIT conducted in partnership with ZVEI, the German Electrical and Electronic Manufacturers’ Association, will take an in-depth look at the MDR. Hans-Peter Bursig, ZVEI Managing Director Medical Engineering Division, has a pragmatically positive take on the imminent end of the transition period for the MDR: “Shortly before the date of application for the Medical Device Regulation, companies from the sector are basically well prepared. However, we are still facing numerous uncertainties and problems in respect of its practical implementation. However, we will also benefit from the MDR in future. With its focus on the complete product life cycle, it can provide support with quality assurance and research and development.” The question of how medical technology firms can derive a business benefit from this burdensome obligation will therefore also be explored by the high-calibre cast of speakers during this session. Tips and progress reports will be provided among others by representatives of the relevant bodies, medical technology companies, sub-suppliers and regulatory experts. Another session moderated by the VDE (Association for Electrical, Electronic & Information Technologies) will look at the special case “Regulation of AI Applications”, because AI-based “self-learning” medical devices represent a particular regulatory challenge. Florian Schlögel, VDE, explains: „In artificial intelligence applications, the decision algorithm is not permanently implemented by the programmer, but is trained using sample data. This requires an adapted procedure for approval. Until now, AI applications are only cleared by the notified bodies if the algorithm is frozen and the learning process stopped. In order to exploit the full potential of artificial intelligence, we need adjustments to the regulatory requirements and guidance documents for manufacturers and notified bodies.” In the Technology Session, experts from exhibiting companies will provide an overview of solutions and technologies for implementing regulatory requirements like those of the MDR successfully and efficiently. All three sessions will be held on the first day of the fair (20 April 2021) and can be downloaded as a recording by registered participants at any time after the end of the live stream. Direct line to MDR experts Alongside the congress speakers, numerous exhibitors will also contribute their expertise on the issue. Exhibitors like TÜV Süd, FSQ Experts, Metecon, Seleon, sepp.med and VDE will offer tools, services and advice on issues relating to the MDR and other regulatory affairs. For an overview of all companies and experts please go to: www.medteclive.com. Participants in the virtual MedtecLIVE & SUMMIT can contact speakers and experts about the MDR at any time by making use of the virtual event’s matchmaking function that allows 1:1 chats and video calls to be easily arranged. Talks and special shows on wearables and additive manufacturing As a trade fair for the entire medical technology supply chain, MedtecLIVE 2021 will also address other trending issues, including additive manufacturing and wearables. The opportunities and application scenarios for 3D printing technology will be covered in the round table discussion “Updates from 3D Printing for Medical Products” on the second day of the fair. At this session, which is organised by a partner from Augsburg, the trade fair EXPERIENCE ADDITIVE MANUFACTURING, use cases from the medical technology environment will be presented by experts from the additive manufacturing community. All participants can then connect with one another in the subsequent speed networking session. In turn, a medical technology special show is being planned for the EXPERIENCE ADDITIVE MANUFACTURING trade fair in Augsburg from 21 to 23 September 2021. This collaboration is forming a bridge between the platforms for medical technology and 3D printing technology. A second virtual special show brings together innovations and solutions from the field of wearables. This special show will be complemented by a Technology Session at the MedtecSUMMIT. The Technology Sessions, which are short and informative pitches by experts from exhibiting companies, are all accessible to trade fair participants free of charge. For the rest of the programme at the MedtecSUMMIT you need to register and acquire a congress ticket. Apart from high-calibre content, the second virtual edition of MedtecLIVE & SUMMIT will deliver an optimised user experience and an even more professional setup. A lot of interactive elements, improved matchmaking function and the continuous moderation of the event in TV-quality from an impressive XR (extended reality) studio create a premium networking experience. You will find the complete programme for MedtecLIVE & SUMMIT, a list of all exhibitors, and information on taking part in the forthcoming round as an exhibitor or registering as a visitor at: www.medteclive.com About MedtecLIVE & SUMMIT The MedtecLIVE trade fair and MedtecSUMMIT Congress & Partnering event is a leading networking platform for the international medical technology scene. The next round will take place virtually from 20 to 22 April 2021, when innovative products, solutions and services from the entire medical technology supply chain will take centre stage. Companies, associations and institutions come together at MedtecLIVE to make contacts, share ideas and create new innovations. At the renowned MedTecSUMMIT, manufacturers, end-users and researchers hold interdisciplinary discussions on the future developments in the sector. The congress is hosted by the Bavarian Ministry of Economic Affairs, Regional Development and Energy and is designed and executed by Bayern Innovativ GmbH. The MedTech Pharma Forum is the institutional sponsor of MedtecLIVE and MedtecSUMMIT.