What are the key changes occurring with the EU MDR?
Kim Trautman: “Firstly, manufacturers are no longer allowed to use data published in the scientific literature pertaining to competitor’s products in the same way to state that their product is equivalent. They must have the specifications for that other device, which is highly improbable unless it is part of the same company/corporation. There will likely be some new clinical investigations or evaluations, depending on the risk.
“Another big change is the risk management and usability engineering throughout the lifecycle of the device. There’s a standard in the risk management community that you can take action to as far as is reasonably practical. The EU MDR talks about taking it to as far as possible; while this may seem like semantics, it’s really not.
“There are also a lot of different requirements for labelling, including the unique device identification (UDI). Beyond the UDI, there are additional demands for risk management, where if risks cannot be reduced to as low as possible, they might have to go on the label or in the instructions for use.”
Are their additional post-market surveillance and other pre-market requirements?
KT: “Yes, post-market requirements go beyond typical complaint-handling, there are more specific requirements such as post-market clinical follow up, whether that be in clinical evaluation reports for regular devices or performance evaluation reports for in vitro diagnostic devices, under the EU IVDR. And then there are new roles and responsibilities for economic operators within the pre-market arena, whether that be the authorised representative, legal manufacturer, importer or distributor.
“Every single one of these changes will indirectly or directly affect the quality management system. To meet these new requirements, manufacturers must break down the silos that traditionally exist between regulatory affairs and quality assurance.”
What are the time frames for the EU MDR and how can manufacturers prepare?
KT: “The main deadline for the EU MDR is May of 2020. Manufacturers are allowed to maintain their current certifications until they expire. However, if a manufacturer makes a ‘significant change’ after May 2020, they have to switch to the new regulation. Therefore, they have to be prepared. While the deadline for the IVD Regulation is May of 2022, those manufacturers must also be prepared.
“Preparations typically start with a gap analysis, comparing the current processes and procedures with what the regulation requires. From there, they need to march though a very methodical, project-managed timeline to start handling some of those gaps.
“Companies have to decide whether they are going to hire additional resources to keep it in-house or if they will be going outside to third-parties for some of these functions. Ultimately, a manufacturer’s QMS must be able to sustain these changes and remain compliant within the requirements of ISO 13485:2016.”
How does NSF International help support companies to implement these procedures?
KT: “One of my big roles at NSF International is training. We are continually producing e-learning resources and face-to-face training because regulations are constantly changing.
“If people haven’t thought of some of these things, there is a fantastic e-learning module on the new regulation. There are also several experts that are ex-regulators who worked in the EU that are also providing many different consulting services within NSF International.
“NSF International goes beyond traditional consulting. There are people involved in clinical evaluation reports, tech file remediation and performance evaluation reports. They are now helping companies remediate those files and keep them updated. A call to action is the biggest message. Companies cannot wait for more guidance, they need to act now.”