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EU MDR: How to Respond to Today’s Knowns and Unknowns

If you’re an orthopedic device company selling in the European Union (EU), your reality is that you have to make decisions based on unknowns set forth by the Medical Device Regulation (MDR). This makes MDR implementation a taxing and unsettling exercise that requires strategic thinking, not just regulatory compliance.

We came across a recent slide titled “Implementation Generally” on the Medicaldeviceslegal blog. The blog’s curator, Erik Vollebregt, a Founding Partner at Axon Lawyers and a previous BONEZONE author on MDR, gave us permission to republish it here. While in conversation, we took the opportunity to ask what companies should be doing today to prepare for MDR and what the new regulations mean broadly for the medical device industry.

Implementation Generally

At the highest level, here are what Vollebregt considers to be knowns and unknowns.

 WHICH

 WHAT

 Known Knowns

 MDR text

 Rolling Plan that keeps changing

 When to apply with Notified Body for a recertification

 Corrigendum – dots, commas and nothing re transition

 Known Unknowns

 Common specifications

 Implementing acts

 What standards will be harmonized

 Basically all guidance (except Medical Device Coordination Group on UDI  and Competent   Authorities for Medical Devices Q&A)

 EUDAMED functionality by March 2020

 National implementation

 Your notified body ready to accept MDR certification application

 Unknown Unknowns

 National enforcement in case of:

  • Bottleneck induced shortages
  • Notified Body failing to deliver MDR certificate timely

 All over the place,   unpredictable, crazy

 Brexit


In considering the numerous unknowns with MDR, we asked Vollebregt what the main takeaway is for companies when they look at this slide.

“The more there is unknown, the more the company needs to think about strategic scenarios,” he says. “Companies are not used to doing that when it comes to regulatory affairs matters. When things remain unclear, it may still be necessary that the company acts. This is something that I’ve seen a lot with medical device companies, especially U.S. companies. If there is not an immediate very well-defined need, regulatory affairs does not get the budget to do remediation, and in the meantime the company loses precious time until it is too late for meaningful remediation. The MDR is of strategic importance to a medical device company, as its European and other international markets that rely on a valid CE Mark for the device are at stake.”

How Should You Prioritize?

With 13 months until the MDR deadline, we asked Vollebregt what he’s advising companies to do today. He offered the following.

The advice today depends on where the company is with its preparations for the MDR, and that tends to differ very much from one company to the next. Also, it depends very much on how well they’ve done in collecting postmarket/real-life data for their devices over the years. Generally, in a one-size-fits-all way, I would advise these actions.

  1. Check whether you are working with the right Notified Body (NB) and whether this NB has applied for designation under the MDR, when they expect their designation and when they can accept your conformity assessment application. NBs are in a difficult place themselves currently with the need to be designated under the MDR (which is a lot of work for them), and their information to clients is not always unbiased, because they do not want to scare away clients. So, they sometimes tend to be overoptimistic about deadlines, or have difficulties planning necessary audits. If you have issues planning audits with your NB or even with reaching them, this a sure sign that your NB is in survival mode and does not necessarily have your best interests as a priority. In that case, seriously consider if the NB is right for your company and whether you should move to another one. There is a big shakeout happening. Some NBs are struggling to keep afloat, closing down or being acquired. Make sure that their problems do not become your problems. Companies often have too much patience with the problems of the NB, and then suffer the consequences of an expired certificate that has not been renewed in time. 

    Conversely, companies should not count on their certificates being renewed at this moment if their clinical evidence is lacking. I see this happen a lot with companies in the orthopedic space. With the MDR in sight, the NB demands clinical data that it did not require before and which the company just doesn’t have at the moment. This is usually the result of lacking postmarket surveillance (PMS) and postmarket clinical follow up (PMCF), and not having data collection practices evolve with the respective iterations of the clinical evaluation MEDDEV 2.7/1 (EU guidance on clinical evaluation, currently in revision 4), which may have looked like a good idea at the time but really catches up with a company later. The NB has the right to require that your data for the device has evolved over time. I find that many companies have neglected this, while at the same time the standards for clinical evidence increased. U.S. companies often do not understand that a CE certificate has to be earned every time, based on the current state of art at renewal. Essentially, once approved does not mean forever approved. If you have an approaching certificate renewal, make sure that you have every bit of data on the device available; same for your MDR conformity assessment application. There is a running joke that MDR is the acronym for More Data Really. That is not an exaggeration, especially now, since many orthopedic implants are up-classified under the MDR to class III. 
  1. Check the impact of Brexit on your organization.

  2. Check whether your product portfolio can be cleaned up to the most important and evidence-based devices in your organization, if you do not have the resources to remediate all of your devices at the same time.

  3. Initiate PMCF activities if you identify a gap in your data quality and quantity. Preferably as an implant manufacturer you have been collecting this data during the time that your device was on the market, and you have it available. Otherwise you may not have the time to collect the required new data before May 2020.

  4. Prepare your quality management system (QMS) toward the new regulation. One thing that is often misunderstood is that an ISO 13485:2016 certificate does not equal compliance with all MDR QMS requirements. The MDR requires significant extra work and a good gap analysis to know what the extra work is for the company concerned.

  5. Make a strategic choice about renewal of your current MDD and AIMDD certificates to ensure having sufficient time towards transition to the new rules in the EU, if you do not anticipate significant innovation of the device in the next five years. As manufacturers, you have the choice between having an MDR certificate by end May 2020 or having renewed your current MDD certificate one last time so it can extend beyond the end of May 2020 until its expiry date or May 27, 2024, whichever is earlier. If you do not expect to be able to obtain an MDR certificate, then this is your option. Even with an MDD certificate renewal, you need to implement most of the procedural framework of the MDR and meet the stricter PMS and PMCF regime. Also, and this is important, you are not allowed to make any significant changes in the design or intended purpose of the device until you have your MDR certificate.

  6. Work on the implementation of the economic operator and traceability regime. You will need to review your distribution agreements and determine who has what new regulatory role under the MDR in your supply chain. This turns out to be a lot more work than manufacturers realize.

  7. Realize that there is no grandfathering. Every CE Mark must be renewed under the MDR sooner (before end May 2020) or later (at the moment between May 2020 and May 2024 that the current MDD certificate expires), and regardless of this most of the MDR will apply anyway as of May 26, 2020, like the QMS, UDI and new PMS requirements. Doing nothing is not an option if the company wants to keep placing products on the market in Europe.

What does MDR mean for the big picture?

A question we’ve received is how will MDR impact the medical device industry in Europe—and globally. While MDR goes into effect in 2020, it’s likely that it will take years to feel its real impact. We asked Vollebregt how he would answer. He gave the following optimistic response.

The MDR will replace the current AIMDD and MDD directives; it’s that simple. The MDR is a regulation with direct effect in the EU member states, so they have no room for their own implementation like they had under the directives. The impact in the EU is that medical devices law will be much better organized in the EU and hopefully more uniform in the way it is applied. Also, traceability and PMS will improve a lot. But it will also be more work for companies, as administratively there is a lot more to do. Globally, I hope that the EU has given a good example for medical device legislation like we have done for protection of personal data with the General Data Protection Regulation (GDPR). The CE Mark has been very successful as a regulatory template and is widely recognized. I hope that the MDR will build on this.



Carolyn LaWell
is ORTHOWORLD’s Chief Content Officer. Erik Vollebregt is a Founding Partner at Axon Lawyers.

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