Why companies need to simplify medtech maintenance compliance ahead of EU MDR

Mark Homer, senior vice president global customer success and head of corporate development for software company, ServiceMax, explains why field service management could prove essential when the EU’s Medical Devices Regulation (MDR) is introduced.

EU MDR was planned to come into effect in May 2020. Although the European Commission has announced the implementation of this regulation is likely to be postponed, companies still need to prepare for EU MDR.

The regulation will bring in stricter rules for assessing medtech devices. It’s the latest in a series of regulations and updates aimed at improving patient safety. Unsurprisingly it is far from straightforward and there will be a transitional period during which manufacturers need to work on their compliance. It’s a similar story in the United States, where a number of related regulations, including AdvaMed’s Code of Ethics are undergoing updates and revisions to accommodate medtech's increasing influence on healthcare provision.

It’s a complex picture – global law firm Akin Gump has gone some way to try and unravel the expected changes – for manufacturers and customers, as well of course those field service teams tasked with maintaining the machines. As these diverse and sometimes complex medtech devices become increasingly essential to everyday healthcare provision, field service teams have to be able to work within the boundaries, quickly and effectively.

This raises a few challenges. If field service teams are to mitigate against compliance risk with medtech devices, meet safety requirements and protect the workforce, they will need accurate records, a digital trail of machine information and any repair or replacement works. This is the bottom line. However, without field service management software, this becomes infinitely more difficult.

How can teams digitise and instantly make available Information about equipment compliance, service visits and recalls without a digital trail? They will not be able to ensure compliance with prescribed work steps and this opens-up medtech manufacturers and customers to potential risks.

Also, given the regional variations on compliance, it’s essential for organisations operating in multiple locations to be able to tailor processes to fit with localised laws. These issues are exacerbated with smaller companies, where there may not be a specialist to lead compliance work. This could result in costly breaches of compliance regulations and lost customer revenue.

What field service management will enable organisations to do is take control of compliance risk by providing a platform on which they can not only digitally track all devices and activity, but also organise work to fit within required guidelines. Field service management tools can automatically recommend and where necessary, despatch technicians to jobs based on skills and certifications. Each job is recorded digitally, including time, parts used, and any corrective actions taken. This is fed back automatically to a centralised database of records.

As regulations become more stringent and regulators more active in their policing, so more organisations will have to demonstrate compliance, especially around maintenance works. This will demand a system that can report accurately on activity, ensuring work has adhered to local regulations on systems management, employee competence, testing and calibration of devices and so on.

Overall, medtech company's risk and compliance should be seen as an opportunity for organisations to revisit and improve their processes to managing and maintaining devices and machines in the field. As Deloitte says in a recent paper, “active compliance can also be a force to support the needs of your teams, and the process and technological tools they use, to be better integrated and aligned in your company's mission.”

In short, field service management is not only de-risking the complexity and vulnerability around medical devices and compliance obligations, it is now also being used as a force for positive change throughout the entire organisation.