In recent years, new regulation has been top-of-mind for medtech companies wishing to continue marketing their products in Europe. In large part, this has meant navigating the requirements of the European Union’s Medical Device Regulation (EU MDR).
Introduced in 2017, the MDR mandates sweeping regulatory reforms that are intended to enhance the safety of medical devices on the European market.
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Compliance requirements currently exist on a staggered timeline: the end of 2027 for high-risk devices and the end of 2028 for lower-risk devices and legacy medical devices, with manufacturers mandated to fall into compliance with the regulation from 26 May 2024.
This will be one of the main topics discussed at the upcoming Outsourcing in Clinical Trials: Medical Devices Europe 2025 conference, scheduled to take place on 28–29 January in Munich, Germany.
Due to a limited number of Notified Bodies within the EU Member States, complex requirements for the provision of clinical data to demonstrate that a medical device meets essential requirements for market approval, and a perceived lack of clarity around the mandatory requirements under the regulation, some market observers have branded the MDR a ‘disaster’.
The first day of the conference will largely focus on the changing requirements the MDR necessitates for market participants, covering topics including the practical considerations for conducting clinical investigations and navigating clinical data requirements for CE mark recertification under the MDR.
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By GlobalDataStephen Gilbert, professor of medical device regulatory science at the Else Kröner Fresenius Center for Digital Health, will open the first day of the conference with a session covering the impact of the EU AI Act on the medical device sector. Also serving as this year’s conference chairperson, Gilbert will highlight topics including the main components of the EU AI Act and how these may complement or add to MDR requirements for market participants, balancing innovation with safety, and strategies to navigate the new regulation.
Later in the day, a panel – featuring speakers such as Pradipto Kolay, global R&D leader at Philips; and Alexander von Janowski, process manager for agile certification of AI medical devices at TÜV AI.Lab – will explore how the agile certification process prototype harmonises the MDR and AI Act and creates a streamlined pathway for AI technologies to meet regulatory standards.
Day two of the conference will feature sessions focused on the evolving relationship between contract research organisations (CRO) and medical device manufacturers – a matter largely being driven by the EU MDR – and the role AI has to play in medical device clinical trials to enhance their design and efficiency.
The day’s opening panel discussion, featuring speakers including Luca Franceschini, clinical project manager at Aboca, and Pavel Kusnierik, head of regulatory affairs at Contipro, will explore topics such as the challenges in communication and project management in the CRO-medtech relationship, and reflect on several successful collaboration case studies and the lessons learned.
Other sessions will see Mark Cregan, medical expert at Medaxis, discuss the evolving clinical trial landscape and the most important considerations for medtech companies while Stacy Gardner, director of clinical affairs at MCRA, will highlight the unique challenges in conducting medical device trials in Europe and the UK.
The conference is hosted by Arena International Events Group, a B2B events company owned by GlobalData, which is the parent company of Medical Device Network.
A full agenda for the OCT Munich conference can be found here.
