April 19, 2016
The medical device industry – A catalyst for regulatory innovations
In the perpetual developing environment of medical devices, international standards, directives and regulations are constantly reviewed and revised to remain applicable for the latest type of devices. Creating solid and robust guidelines is a challenge, which should not be underestimated. The International Standard Organization recently released an update to ISO 13485. This is not a revision on its own – More important changes in the regulatory framework for medical devices are about to be released in 2016 or early 2017. For example, the Medical Device Directive and the Active Implant Medical Device Directive will be merged into a single Medical Device Regulation.
Let’s take a closer look in the complex world of the regulatory minds. The EU and the member states, should anticipate on innovations and create a framework that effectively ensures that devices are safe, effective, reliable and of good quality. But how can they today imagine what kind of devices will be developed in the next 10 years?! It is therefore challenging to create a regulatory framework that is strong and specific to ensure development of safe and effective devices on the one side, but also broad enough to remain applicable over a longer period of time on the other side. In the ideal world, we are looking for a regulation that is contemporary and allows future innovations to be developed within interpretation boundaries of the regulations. However, intentionally allowing variance in interpretation of regulations also raises the question whether this would lead to a desired situation. It actually may be justified to ask ourselves the question: Who is regulating what? Is the medical device industry being regulated or should we say that the medical devices innovate regulations?
With the current pace of creating new technologies the medical device industry can at least be seen as one of the catalyzers for regulatory updates. The EU and the member states are clearly challenged to create a control mechanism that reduces the extend of actual control, but are they willing to accept differences in interpretation between companies and authorities? One could argue whether this is contrary to the scope of a regulation, but these days it may be more important creating regulations that stimulate the continuous innovations and therewith serving healthcare.
Although creating and revising regulations is a complex process, innovation of the regulatory framework will be important to ensure appropriateness for the medical device industry.
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By Alwin van den Broek
Peter Ruys, Regulatory Affairs Medical Devices