The EU is flexing regulatory muscles, and the new Medical Device compliance deadline is January 1, 2020. With only a few months to go, it is of the utmost importance to assess your situation today...Are you on track to be ready?
We sat down with Mickey Huber, Director of QMS Solutions at Process Stream, to discuss what he is seeing on the ground with Global Medical Device companies, as they prepare for the daunting, yet critical, sprint to the finish line.
What are you seeing day-to-day with your clients as they prepare for EU MDR 2020?
EU MDR 2020 stipulates 2 main parts that Medical Device manufacturers must adhere to: Product Registration and Conformity; and Post Market Surveillance and Vigilance Reporting.
To briefly summarize, for Product Registration and Conformity, a Medical Device company must get re-audited, and then re-register (declare conformity for) all of the products they intend to sell in Europe. The deadline for this is May 2020, and without this, companies must stop selling products until this is completed. So, understandably, most of our customers are focused on this aspect of the regulation.
However, recently, we have seen some movement with customers regarding the changes to Post-Market Surveillance and Reporting, namely the use of the new Manufacturer’s Incident Report template (MIR). Given that the new form is ALREADY live and will be mandatory in a shorter timeline than MDR Registration (January 2020) this is rather concerning to us and most-pressing from our perspective. We have been looking into the reasons why there has been such a late start for this aspect of the regulation. Here are our findings to-date:
- Confusion on the applicability of the new form - In many conversations, companies have interpreted that the form is only applicable once they are audited and certified under MDR. However, this only applies to reporting timelines for incidents, not the use of the new form. The new MIR form is to be used for existing products under MDD, as well as into the future for MDR, and this only made the management of existing product and incident data that much more complex!
- Manual submissions - Given the lack of clarity on new submission regulations, companies are assuming an ability to manually fill out the form and submit, as they have been doing thus far. Maybe the volume of submissions they currently manage is rather small, and they think, at least temporarily, they can handle the load. But, with the new MIR form, the amount of data need has more than tripled, as older products must comply with these new data requirements, and the timelines are shortening.
- EUDAMED availability - Under the new EU MDR law, a new centralized european database, EUDAMED, will be created to handle registrations and submissions of the MIR form electronically, like the FDA requires for eMDRs into the MAUDE database. EUDAMED is currently unavailable and delayed with the current estimate for the Vigilance module to be made available in November 2020. Many companies are waiting until EUDAMED is available to implement the changes to the new MIR form. We strongly advise against this, as the new form, regardless of EUDAMED availability, is currently live and legally required for January 2020!
What are the biggest challenges you see your clients face approaching EU MDR?
Well, the first challenge is getting started! Many companies just aren’t working on the MIR forms and updates to their Post-Market Surveillance in TrackWise, and are waiting until they have the registration aspect handled first. Also, the need for this level of system enhancement is still with most businesses, and it isn’t being requested of their IT departments, who actually oversee those very systems.
The second challenge, for those companies that have started EU MDR initiatives is swinging too far to the other side. EU MDR is the newest and shiniest piece of regulation right now, but it certainly isn’t the only one. From a reporting submission perspective, even after the new law is effective, reporting to FDA using eMDR will require about 10-times the volume of reports to the EU. Then, there is still the rest of the world to worry about. When designing systems changes to accommodate EU MDR, be equally mindful of the others as well.
What advice would you give to an organization just beginning their compliance strategy/execution for EU MDR 2020?
START NOW! If you haven’t started working on EU MDR, or haven't adjusted your MIR reporting, and the data necessary for the same, you should start quickly. January 2020 is right around the corner, and this is a very big task. With that said, be sure to get your IT departments involved from the outset with regard to strategy/implementations. It is important to note, while it doesn’t directly impact the hard-deadline of marketing products by May 2020, the notified bodies are looking for (at least) two months worth of solid reporting before you get re-certified. Therefore, your efforts to use this form are reviewed, considered and consequential.
Also, don’t underestimate the magnitude of this data challenge! This isn’t just for new products being placed on the market, or grandfathering-in of old complaints 'as is'. The new MIR form, and EU MDR regulation requires new data for previously marketed products. This gives them new identifiers in EUDAMED, even if they didn’t have a UDI at the time they were manufactured. This also includes remediation of old complaints to now include IMDRF coding, even if they weren’t coded at the time the complaint was closed, or if IMDRF codes didn’t exist yet to facilitate similar incident trending.
You will also have to get, to the best of your ability, distribution data going back four years. This needs to be broken down by product, by year, and by country (around the world), to do trend analysis, even if you have not collected this previously. All of these specifics will also have to be on-hand using a quick and automated method for the report submitters, as with the shortened timelines and increased requirements for submission, and after an incident is investigated. The submitter, at that point, is left with relatively little time to compile this data and submit on time.
In the end, this will probably force a brand new, streamlined process, and better analytical abilities for your post-market surveillance practices. But, it won’t be easy. There is no better time than the present to get started!