Almost six months have passed since the new regulation for medical devices, MDR, was imposed in EU, even though the work to ensure that we as a supplier follows the new regulation started long before that.
Anna Sahlholm and Anna Wik at Abilia recently hosted two seminars in Umeå, Sweden, where they talked about how Abilia is working with MDR and where they shared knowledge we’ve gained along the way. It is important to continuously work with quality matters to ensure our products and processes meet the high requirements defined in MDR, and to communicate with the organisations we have cooperation with.
“In general, we receive many questions from prescribers and NHS/local authorities regarding the regulation when using a number of products and accessories as a system. During our seminars in Umeå we talked about who is responsible for what, how to make a risk analysis, and what could be the consequences if using consumer devices instead of medical devices. For example, medical devices have tougher requirements related to technical security and to the documented clinical evidence compared to consumer devices”, says Anna Sahlholm, Medical Science Liaison & Portfolio Manager at Abilia.
Basically, MDR is about patient safety and to guarantee that a medical device used to compensate for a disability is safe and that intended use gives the wanted effect. A detailed technical description and clinical evidence should be able to prove this. A CE-mark on the medical device states that the product is approved from a MDR perspective.
“Our complete development is built on research and clinical evidence, and our assistive aids are developed for specific user groups. Thanks to our competencies within different disabilities, we can develop user friendly assistive tools that also considers risks that may arise during use”, continues Anna Sahlholm.
One of the differences with the new regulation compared to the old one, is the requirement on feedback. Anna Wik, Manager Quality, Sustainability and Regulatory Affairs, says “Abilia has long-since had a good dialogue with many of the external players on the market, such as NHS/local authorities and users, and hence secured their feedback. The difference now is that our processes are clearer when positive and negative feedback are reported back to the concerned part of the organisation. In this way, we secure our work with continuous improvements, while at the same time increasing security for the user.”
At the two seminars, the participants were mainly from NHS/local authorities but there were also prescribers, representatives from municipalities and other suppliers in the room. The participants were committed and there were many interesting discussions with Anna and Anna, but also among the participants themselves. One thing that became obvious, was that there is still work to do to be able to fulfil the role as a distributor in an efficient way. New processes are needed at all stages, from the distributor, via the NHS/local authorities and municipalities to prescribers that might have its own warehouse that is also covered by the regulation.
MDR requires that all medical devices should be tracked during its whole lifecycle. This means that many players need to cooperate to ensure the product journey all the way to the user and the feedback back to supplier.