Home News & Events News overview The medical device industry – A catalyst for regulatory innovations

Alwin van den Broek

Clinical Study Manager

April 19, 2016

The medical device industry – A catalyst for regulatory innovations

The regulators versus the medical device industry, who’s in the lead?

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.

Recommendation: Do you want to stay up to date for the upcoming changes in the European Medical Devices Regulations and learn more about the challenge of creating them, follow us on LinkedIn and/or Facebook.

By Alwin van den Broek

Factory CRO for Medical Devices Acknowledgements
Peter Ruys, Regulatory Affairs Medical Devices


About the author

Alwin van den Broek Clinical Study Manager

Alwin has a special interest in the regulatory frame work and data privacy regulations.

November 17, 2017

Start Sooner, Run Fast, Finish Faster – The New York Marathon 2017

At Factory CRO we believe that physical fitness stimulates people to get the best out of themselves. Besides the positive energy, it increases company engagement and team spirit. In light of this philosophy, 12 Factory CRO runners successfully completed the...

Pre Market
March 21, 2018

Clinical Investigations – What changes because of the Medical Device Regulation?

  Does the MDR change your Clinical Investigations? April 5th 2017 was a historical moment for the medical device industry: the Medical Device Regulation (MDR) was adopted by the European Union. Beginning May 27th, 2020, after a 3 year transition...

Pre Market
February 27, 2018

One Medical Device Trial Fits All! ISO 14155 as a Standard for Your Foreign Data Submitted to the FDA

There is interesting news in the medical device world that may impact your clinical strategy! On February 21, 2018, the FDA released its final ruling on the acceptance of data from clinical investigations for medical devices. With this amendment to...

Pre Market