The fog of war: crunch time in the regulatory cycle

  • Posted on 08.11.2018

The fog of war: crunch time in the regulatory cycle

20160517 Ronald

Ronald Boumans

Senior Regulatory Consultant at Emergo


As I followed the 1,075 km cycling route starting at the Belgium coast and ending in Basel, Switzerland, along the Western Front line of the First World War, I began to consider the plight of soldiers and generals a century ago. For military leaders, it was impossible to have an overview of what was happening on the battlefields; those in the trenches could see no more than 200 metres in front of them, with limited visibility left and right. Nobody had a full understanding of what was going on at all levels simultaneously. 

There is a parallel to be drawn with the current turbulent times for medical devices in Europe. Keeping devices on the market currently appears to be an endless battle with deadlines. In 2013, the unannounced audit program was introduced, and implemented by Notified Bodies in 2015; in 2016, Revision 4 of the MEDDEV on Clinical Evaluation was launched; 2016 also saw the introduction of a new version of ISO 13485 on quality management systems for medical devices; and in 2017, the MDR and IVDR were introduced, with a 3 and 5-year transition period respectively. 

EU medical devices rules are not the only front. We’ve had the GDPR, new requirements for the Canadian and US markets, and there are indications that the updated version of ISO 14155 on clinical studies will be published soon. All these changes require additional work and most of them deeply impact CE-marking. Missing one of these deadlines can lead to a device no longer being able to be placed on the European market. 

This “perfect storm” may look like a local European problem, but manufacturers from all over the world depend on the CE-mark. In hospitals worldwide the loss of a single certificate may cause a cascade reaction of unavailability of products and procedures, because so many are interdependent.

Is anybody in charge?

This brings us back to my observation during that cycling tour: does anybody have a full understanding about what is going on? 

Frontline regulatory staff focus on deadlines for specific steps in the regulation of a specific device. Their managers worry about the certification of a product group. I see CEOs struggling with significant budgets that come on top of Marketing and R&D. And I wonder whether Ministers of Health in Europe (and elsewhere) are fully aware of what may be coming their way. 

With so many fronts open at once, we must choose our battles carefully. In my view, we should focus on the three- and five-year transition times for the MDR and IVDR. The transition times, and the so called ‘grace period’, are hard fought compromises between negotiators drafting the final version of the Regulations. It will not be possible to change anything without a very good reason. 

Studying the history of wars in general, including World War I, makes clear that successful leaders have an opportunistic approach. They never waste a good crisis. There is another major crisis currently at our doorstep: Brexit. The negotiators could not take this disruptor into account when the Regulations were drafted. Brexit may provide the perfect argument for extending transition time lines.

If this approach fails, Brexit could still provide a good reason for reconsidering that position. In case of very hard Brexit, we may see what happens if healthcare providers suddenly face disruption in the supply of devices. This may change priorities at the highest political level.

For now we should focus on keeping devices CE-marked. Reach out to politicians and make them aware of this risk for continuity of care whenever you can. In the meantime, may I also recommend that you to take up cycling – a great way to stay healthy and contemplate battlefield strategy.

The comments are closed.