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


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


June 22, 2016

Am I wearing a medical device?

Working in Factory CRO’s clinical operations team, it’s all about collecting data and setting up clinical trials. As a movement scientist I was used to collect my own personal data during my training in university, but the new Garmin watch...

Pre Market
October 26, 2017

Factory CRO Acquires MileStone Research Organization, Builds North American Presence

Bilthoven, Netherlands — Factory CRO, a leading global contract research organization focused on medical devices and IVDs, has announced the acquisition of MileStone Research Organization. MileStone, located in San Diego, specializes in clinical research and reimbursement solutions for the medical device...

Pre Market
September 6, 2017

Unique Device Identification (UDI) System – Path toward Global Harmonization?

On Sept. 24, 2013, the Food & Drug Administration (FDA) mandated 78 FR 58786 (the UDI Rule), herewith establishing a unique device identification labeling system in line with the requirements of 21CFR830.20. Medical device labelers must submit product information to...

Life Cycle