crunch time

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...