Time to put your hand on the plough!

There is a time for everything, a wise man once said. A time to celebrate and rejoice, but also a time to work. Or as the old Dutch saying goes, a time to put your hand on the plough and go to work. Hard work, to change the barren land into the fertile soil from which we may later reap the fruits and veggies. That is what the 2018 year will bring us for EU MDR compliance. We’ve fed the horse and we’ve prepared the plough, made it sharp with our gap assessments, and perhaps some strategic rationales. And when we were starting early enough, for some of us even a portfolio rationalization and a first version of the implementation plan. However, if we want to be ready to invite our notified bodies for a compliance audit to the new regulations by the time they might get their designation in spring 2019, then the implementation should be largely done in 2018, with a bit of final work and finetuning in the first half of 2019. 

However, how to get there, how to get started is a much-heard question these days. How to make sense of the many gaps we’ve identified in the tech file assessments, the clinical assessments, and the QMS assessments. Many seem to be lost in the mist that some call “analysis paralysis”. And it is hard work to get out of that state, into a plan with actionable items. 

- It might be worth reducing some of the detail in your analysis at this stage, and keep it in reserve for the finetuning stage;
- it would be essential to group deficiencies that have a joint root cause, and/or have a similar solution;
- it seems logical to assign each deficiency to a person, a function or a task force, depending on your company size and the structure of your MDR program;
- and consider more ways to streamline the work toward a workable implementation program.

One consideration for this stage revolves around the issue of consistency. It is great at this stage to divide the work over the available resources, in-house as well as external. However, one should be vigilant, as a key change in the EU-MDR is to look for consistency in wording of claims, intended use, intended purpose. And essential links between risk management, clinical evaluation plan(CEP), clinical evaluation report (CER), as well as PMS documents such as PMS plan, report, and PSUR (periodic safety update report) should be well established.

To not lose essential time, it is key to get started with the time-constraint deficiencies. 
- Think of establishing additional clinical data in PMS phase for legacy products (PMCF), based on a smart clinical strategy that might allow you to use equivalence within the clinical data of your portfolio. 
- Think of changes in your supply chain that will be needed for those cases where supplier do not wish to continue in the new transparent device culture.
- Think of early renewals of your current certificates to allow for an efficient use of the soft transition where needed.
- Think of adding a new notified body, of shifting portfolio elements between notified bodies, etc.
- Think of all the changes that will take a year or more to get done, and put them on the priority list.
And then get started with them, even when your implementation plan is not yet fully ready. Many are waiting until the big plan unfolds, and all is clear, guidance is in place, and notified bodies answer all your questions on interpretation and implementation in a timely fashion. However, the waiting will take a lot of the valuable time you have. As such it might be best to take your own decisions, use the best possible interpretations, and get to work. Hands on the plough. Step by step.

Non desperandum! Do not despair…., but if you do, give us a call and we may help you build the implementation plan!


Gert W. Bos, PhD, Fraps
Post date: January 15, 2018
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