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MDR and IVDR preparations advancing full speed in lockdown times
As countries throughout the world stepwise move towards partial and full lockdown, I believe we should embrace the fact that we work in healthcare, and that we actually can continue to provide valuable access to medical devices and
. And whilst QA/QC functions would largely continue in the production facilities, RA and medical/clinical staff start working remotely in most cases. And although having kid around as schools might be closed is a new phenomenon, it appears that many are very active and productive. Focus on getting things done in times of pressure.
Facilities are around and we have all been using them, Skype, Teams, Zoom, RingCentral, you name it, we are deploying them hourly to connect. And crucial meetings with authorities, Notified Bodies and others are even easier to schedule as many are facing time alone with their laptops. And authorities with the relevant stakeholders have been able to continue producing guidance this week on crucial topics such as clinical evaluation of medical device software, class I use of MDR grace period, significant changes in grace period, implant cards and changes to UDI-DI.
The question I currently get posed most often is if the
will be postponed; and the answer at this moment still is no. The only realistic option is if the European outbreak management team will issue an emergency measure, like the one that clarifies rules around allowing non-CE-marked medical devices into EU that was published earlier this week.
But even in case there will be a temporary measure, the final deadlines will not be expected to shift. And working with your notified bodies will turn out to be more complex than before, as it related to doing the audit parts of the MDR/IVDR conformity assessment, given travel bans and production site closure for non-essential staff and others. Some notified bodies have done emergency remote audits, but they are far from ideal, and certainly incomplete. Most of them are used for the purpose of being able to extend certificates and allow companies a bit longer time into the grace period for their MDD and AIMD legacy products.
So, what can we effectively do? Focus on things that are best done from home: writing clinical evaluation reports, biocompatibility strategies, PMS and PMCF/PMPF plans, and many other documents needed to construct the new compliant technical documentation. But as more and more people will work from home, keeping documentation consistent is going to be challenging. For that upfront agreements and strong cooperation and mutual trust is needed. And positive behaviour. Starting with design inputs, required marketing/clinical claims, base documents such as claim sheets and other statements will not only have to be made at the start of building a file, all involved should adhere to them. And if truly needed, open a debate on changing its content. From that, intended use and purpose can be derived, technical GSPRs can de addressed, usability and clinical reports will follow, and risk management can be finalised; ultimately labelling, IFU and marketing materials may be drafted, consistent with the claim sheets and further documentation. And then an independent check on completeness and consistency should follow, from a separate review team, either internally or externally sourced.
From our side, we see a rapid transformation for some activities; mock audits are changed to virtual readiness checks; dossier support is enhanced with consistency checks and virtual conflict resolution meetings; face to face in-house training is changed to web-based training and interactive discussion sessions on key topics, and so on.
What is core to understand is that we actually might be speeding up the process of building the technical documentation from MDR/IVDR compliance. With non-essential meetings halted, all focus is now on productivity. And I’m happy that even when working from home, the support and interactions we have in our line of work can largely continue. And the informal parts of our interactions? We’ll make up for our losses in due time, when we meet again face to face. Until then, let’s meet virtually, and make the best use of our quarantine-time!
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Gert W. Bos, PhD, Fraps
Post date: March 19, 2020
Medical Device Regulations
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