Complying with the MDR is easier said than done

The introduction of the MDR legislation brought with it a significant package of stricter safety requirements for medical devices. This European regulation has been in force for medical devices since May 2021 and thus replaces its predecessor, the MDD. Naturally, everything with the aim of increasing patient safety and ensuring that innovative tools remain available to patients (Source: National government). However, this package of safety requirements should not be taken lightly. During the Medical Electronics event, several specialists will provide tips and tricks to make products MDR-proof. Want to know more about this? Then take a look this website.

Common pitfalls when preparing technical documentation
In many cases, certification by a Notified Body is mandatory in order to bring a medical device to the market. But how do you prepare a technical file? How do you determine whether or not you should do a clinical trial? What are the points of attention regarding regulations regarding new developments such as wearables and telemonitoring?

Kiwa Dare is such a Notified Body with a special focus on medical electronics and software. Natascha Cuper shares in her presentation commonly seen pitfalls when drawing up technical documentation and providing insight into the requirements of the MDR.

Medical device software
In addition to the hardware design of a medical device, the software must of course also be sound and (often) also comply with the MDR. This again brings challenges. Sreenath Sukumaran discusses these challenges on behalf of BSI Group. During the day this session the evaluation of software for medical applications is examined. In addition to zooming in on the requirements package, documentation and standards are discussed. Sreenath uses her own experiences from the field to illustrate.

Innovation in an existing medical device
Once certified and on the market, the possibilities to change a medical device become very limited. The design and associated documentation have been approved by regulatory authorities, production processes and supply chains have been established, and finally budget and resources have been allocated to other activities. Yet a product change is sometimes necessary, desirable or unavoidable.

With the arrival of the MDR, many situations as outlined above arose. Nico Zeeders and Maria Dullaert use an example from their own practice Unitron Regulatory in op the impact of a seemingly simple change in the defined use of the product, in its design, manufacturing processes and documentation.