So, what is everybody up to these days? Scheduling a family summer break or frantically working on the MDR project? Most important before you leave your laptop and find some quiet reading spot on a beach with a nice view, is to ensure you have funneled the bottlenecks you have so far identified into the clarification machines in Europe. And of course, you may add your suggestions to the growing list of ‘mistakes’ that are being recognized by the legislators.
Key bottleneck number one identified at this stage is the fair and thorough, and hence time-consuming, designation process for notified bodies. Time many fear we do not have to spare. But processes must be followed, and following the first round of applications of notified bodies by the end of the year, many indicate that 2018 will be used to work on designations. First wave of notified bodies hopefully will be designated by the end of 2018 or early 2019, so they have a year and spare to work on during the hard transition time. That would leave less of the product portfolios hanging by threads in the soft transition mode. Nothing we can do on this, except for some pushing and of course staying connected to your notified body(ies).
Should you wish to compare the status of where you are, then please try out our compliance status app. The underlying database will be regularly refreshed, so on given moments you can re-tune your status.
A second bottleneck many see, is the restriction in using equivalent device data to support your clinical evaluation on high risk devices and implants if you do not have a contract that gives you permanent access to your competitor’s equivalent device technical documentation. A sheer impossibility, that only in special circumstances might see the light. And despite this determining factor, companies appear to be very hesitant to start any PMCF clinical data generation, even if they have budgeted for it.
A third bottleneck lies in the products that will need an MDR certificate at the Date of Application. Class IR products, MDD class I products that will be up classified (e.g. many software tools), etc. As there is no certificate, so use can be made of a soft transition period. Hence the notified bodies would need to prioritize these applications once they finally get their designations in place. Hard to imagine that new clients will be able to persuade them to not spend the time on their life-long clients first.
In itself not a big thing one could think, but the fourth bottleneck is heavily in people’s minds. That is the huge task of building the EUDAMED database that forms the core of the new EU system. Yet rules are in place for the case where it will not be ready in time. And although the EU Commission is still positive on the task at hand, one should start preparing for the alternatives, e.g. storing the data for later backfilling into EUDAMED once that goes live. Ideally with an XML filter, specifics of which might hopefully be shared in time.
The UDI system itself is reflected on as the fifth bottleneck, as the wording do not seem to match, and assumptions need to be made to get all requirements into a single system. Hence the guidelines that are under development should hopefully get to us shortly.
A sixth bottleneck is the detailed consultation of substance based medical devices. As costs for redesign and validation to meet the special consultation requirements will be high, most of such products are anticipated not to see the light of day under the MDR anymore.
Further bottlenecks include some of the reclassifications, the OBL construct that are diminishing into virtual manufacturing, and the unclarities surrounding the soft transitioning, to name but a few.
To be able to know that you can relax on the beach, it is good to realize that by now the gap assessment, a portfolio assessment and rationalization should be getting on their way. Next, also first budgets for the implementation phase need to be brought in place timely into your budgeting cycle. And if you are still concerned, you might wish to take a good read with you to the beach, such as the “MANUFACTURER A-SERIES, 101 information sheets answering 108 questions on the new Regulation on Medical Devices (MDR)”, available from www.mdlaw.eu. It provides suggestions to some of the above-mentioned bottlenecks…
Time is now also 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 and to shift notified body in case you have reason to believe they might not timely support you into the new regulations.
Should you wish to discuss your program and the regulatory details with your peers, then please join one of our EU MDR trainings in Europe or US.
Should you have any other demand, then feel free to contact me. Always happy to discuss some details!