Daily Newsletter

12 January 2024

Daily Newsletter

12 January 2024

How is Europe’s MedTech industry navigating the EU MDR?

The upcoming two-day event delves into what medical device developers need to know about EU MDR and utilising AI in medical device trials.

Phalguni Deswal January 11 2024

The technical documentation requirements of the EU’s Medical Device Regulation (EU MDR) can be exhaustive and resource-consuming. At the upcoming Outsourcing in Clinical Trials: Medical Devices Europe 2024 conference experts from across the industry will dissect the challenges and opportunities of running device trials in Europe and explore how artificial intelligence (AI) is impacting the sector.

The meeting will take place on 30-31 January in Munich, Germany and open with talks on the use of AI in trials. MedTech has embraced the use of AI to develop efficient diagnostics and optimise workflows and sessions will cover how AI can help accelerate trial analysis and regulatory compliance.

The first day will host panels on selecting optimising trial endpoints and endpoint selection in medical device trials. The panels will also highlight how small and medium-sized companies can optimise their resources in terms of trial endpoint selection, outsourcing strategies, and using real-world data.

The day will also host a panel discussion on the challenges of working with contract research organisations (CROs) and how to mitigate these. The session by Stefan Meyer, Implandata Ophthalmic Products’ chief technology officer, will discuss strategies for managing CRO partnerships and finding the balance between in-house expertise and CRO to best optimise capital.

The first day will present a case study of developing software as a medical device. The use of software and apps as a medical device has been increasing, however, the regulation in the field can be challenging to navigate. The session hosted by the CEO of the dermatology company Scarletred, Harald Schnidar will discuss how companies can test software as a medical device through clinical trials.

The second day will host two sessions on EU MDR , one on MDR Article 61.4 and another on the in vitro diagnostics regulation (IVDR). John Thomas, the director of programme delivery at Premier Research, will talk about the impact of claiming equivalence and the performance and safety requirements for a clinical investigation of implantable and class III devices under MDR Article 61.4.

The conference is hosted by Arena International Events Group, a B2B events company owned by GlobalData.

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