Today marks yet another milestone in the EU-MDR development: the painters have been working diligently in the last weeks on the legal-linguistic balancing of the wording, and the final brush strokes have been placed. Then the Masterpiece is ready, and the painters can step back to have a look at their accomplishments. But first we enter the so-called 'period of silence', in which the masters can have one final look to see if any last detail needs brushing-up.
What we will see when we look over their shoulder is the larger picture. The color scheme, the type of brushes, paint and technology used. We will see the key elements of change in clinical data requirement, in supply chain management, in responsibilities and liabilities, and in transparency through EUDAMED and summarizing documents open to the public. Now that the final wording has been found, the formalization in the European Institutes can take place, and publication can be set for early this summer. The signature of the painter can be added, and the painting is ready to be placed on the wall.
When I reflect on some of the brilliant paintings I have seen in my life, they typically are a place to come back to, and spend some more time studying the details. To look at the use of symbols, meaningful colors, differentiation between very precise handiwork and more sketchy details in other places. And it is exactly that what we will see when we study the MDR. Economic operators are defined in detail, as is the requirement on clinical data generation. But other areas are left vaguer, like the wording sufficient, typically used in combination with the clinical data, or for example details on UDI that are deferred to later additional legislation.
But let’s be honest, even without all the parts of the painting being as detailed as the other, the elements are clear enough to get started. What we observe in projects we currently run, and workshops we have held, is that based on the larger picture, and the key changes that are obvious on first or second time reading the documents, there is sufficient base to make a first gap assessment, a portfolio assessment and rationalization and to calculate rough budgets needed for the implementation phase. If you have not started yet, these are the steps to engage in now. For the next phase, however, the details can be as important as the larger picture; details such as transitional arrangements, elements of which have been debated all the way to the end.
As soon as in the next week or so the text for final vote will be ready and available, it is time to move into the next phase of planning the implementation. Final checks on the portfolio assessments, on choices prepared to remove products, to sell off divisions and/or to focus on key products and new development projects. To ensure the first wave of products will make it into the MDR, the ones critical to continue the business where substantiation with a full dossier including sufficient clinical data to support the new level of compliance is feasible. Some choose to leave a second wave open, if there is time, if there are resources, of products that are less critical for the business, or where the gaps are quite substantial: such products might be made MDR compliant in a later phase.
Time is now to finalize classification reviews, to finalize rationales on clinical data requirements and their exceptions, on re-certification strategies and on decisions with which notified bodies one continues. To replace suppliers that are unwilling or unable to follow into the transparent new regime. To sketch the outlines of the individual painting your company will represent.
Should you wish to discuss your program and the regulatory details with your peers, then please join our modular interactive workshop based EU MDR Program
I look forward to seeing you there, to help you on your way forward.
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