One of the main challenges for medical device developers is ensuring clinical trials meet the expectations of all regulatory authorities in the regions where they wish to release.
This will be a significant point of conversation at the 14th Annual Outsourcing in Clinical Trials: Medical Devices Europe, which is set to take place in Munich, Germany, on 27 and 28 January.
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The conference will bring together experts, innovators, and decision-makers across the medical device clinical trials landscape to explore new solutions and advance the efficiency of medical device trials across Europe.
Attendees will have the opportunity to meet and hear directly from key MedTech manufacturers and solution providers, gaining actionable insights to streamline clinical processes and accelerate overall trial timelines.
The conference will feature presentations from over 30 senior-level clinical operations and regulatory affairs professionals from medical device companies, offering their expertise on conducting trials effectively, partnering with contract research organisations (CROs), and navigating complex regulatory pathways.
IVDs on agenda for first time
This year introduces a new stream on In Vitro Diagnostics Performance & Validation, chaired by Fatima Bennai-Sanfourche, senior director of QA & RA compliance for Medical Devices and eHealth at Bayer. The sessions in this stream will address the latest developments surrounding the European Union’s in vitro diagnostics regulation (EU IVDR), post-market performance, and advances in diagnostic technologies.
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By GlobalDataRegulatory experts to provide guidance
One of this year’s standout sessions features Leslie Pibouleau of the European Commission (EC) and Alexandra Poulsson from the Norwegian Medical Products Agency, who will provide invaluable advice on strengthening trial strategies through HTA-aligned evidence.
Another highlight is an audience-driven Q&A session on day one, led by Dr Tonia Jeiter, associate director of clinical R&D at Alcon and former clinical team lead at TÜV SÜD, who will offer practical lessons learned from a notified body perspective on aligning clinical evidence with EU Medical Device Regulation (MDR) expectations.
The discussion will focus on bridging gaps between reviewer expectations and sponsor realities and optimising clinical trial design and submissions for smoother approvals.
The conference is hosted by Arena International Events Group, a B2B events company owned by GlobalData, the parent company of Clinical Trials Arena. A detailed agenda for Outsourcing in Clinical Trials: Medical Devices Europe 2026 can be found here.
Find out more about the event and register to attend on the Arena International website.
