The new EU Medical Device Regulation is effective since the 25th of May 2017, which means that the Medical Device sector needs to increase its compliance level.
To help you understand the impact of the EU MDR, we have asked one of our experts to share her first experiences from a Regulatory consultant’s perspective, and therefore, we have set up an interview with Inette Nieveen. She has been involved in complex MDR implementation projects and is able to identify critical bottlenecks in the process.
Inette, what are the biggest changes in MDR for medical device manufacturers?
Honestly, this question is rather difficult to answer. There are massive changes, but the extent to which medical device manufacturers will need to adapt and implement changes depends on several factors. It will definitely have a strong impact on their Quality management - and Post Market Surveillance systems, the technical documentation and the level of clinical evidence that is needed to support claims and intended uses.
It might lead to upfront investments in clinical investigations, due to a lack of sufficient clinical data, to keep products on the market in the future. For a number of devices these investments will not be worthwhile, and they will probably be phased out in the transition phase. In many cases a portfolio analysis is needed to determine what the future portfolio will look like, and what investments are needed to become MDR compliant. The question will then be if the return on investment will be feasible or not. On the other hand, I suppose new opportunities will arise, as other players in the market may need to phase out part of their product portfolio.
Let’s take the impact on the technical documentation. You might begin with a GAP assessment to review the current level of compliance. In addition, you could be faced with the possibility that the device is no longer covered by the new regulation, or with a re-classification to a higher risk class, due to new or changed classification rules. A transition plan might be needed if classification necessitates new conformity assessment or (extra) consultations from competent authorities, EMA or expert panels.
Substance based devices will now be classified under rule 21, and many of them will end up in a higher risk class. Invasive substance based devices need to add detailed information to the technical documentation regarding studies in relation to their behavior of these substances in the body, possible interactions, local tolerance, and toxicity.
Annex II of the MDR clearly states what is required in the technical documentation. But also, that this documentation should be drawn up by the manufacturer and shall be readily searchable. In practice, this will mean the end to the practice of own brand labeling (OBL), unless the OBL manufacturer has full access to the technical documentation and post-market surveillance data. This process will be tough to handle. Only with detailed contracts, allowing full access and full cooperation, one can continue the existing practice. A large portion of the current marketed devices are actually OBL products. This will definitely have a big impact on many manufacturers and I will not be surprised when a big number of branded products will disappear from the market.
But I expect the biggest impact from the stricter requirements for clinical data the MDR imposes on manufacturers. MEDDEV 2.7.1 on clinical evaluation has been published in June 2016, already underlining more strict expectations on this topic.
One of the most critical changes is the enforcement to largely rely on own clinical data to support claims, intended use and the safety of the device. Many devices currently marketed in the EU base their clinical evaluation on equivalence. Claiming equivalency however, will become hard, as the characteristics shall be similar to the extent that there will be no clinically significant difference in safety and clinical performance of the device. This, in combination with the fact that the manufacturers will need to have ‘sufficient levels of access’ to the data of the equivalent device (most common of a competitor), will cause that equivalency cannot be claimed in most cases. Manufacturers will be forced to conduct new clinical investigations and post-market follow-up studies and gather more safety data.
Manufacturers will not only need to upgrade their current clinical evaluation reports and reduce their reliance on equivalence. They should plan to change their quality management and post-market surveillance system, enabling them to pro-active and systematic (trend) gather and analyze data on quality, performance, and safety, throughout the lifetime of the device. The MDR has a strong focus on safety and forces manufacturers to perform PMCF, being a continuous process that updates the clinical evaluation. New are the periodic safety update reports (PSUR) to be prepared for each device (Class IIa, IIb or III) or each category or group of devices summarising the results and conclusions of PMS data, including PMCF and volume of sales, the population of users and frequency of use.
Due to these new requirements, I think, manufacturers will need to start making plans now and allocate budgets to ensure that they actively gather new clinical and PMS data in time.
What are your own experiences with the EU MDR?
I already had the opportunity to support several of our clients to prepare for the new MDR. I conducted GAP analyses of Technical files, Quality Management Systems and Clinical data and reports to address the major compliance gaps. Based on those high-level assessments we prepared an implementation plan, starting with the time critical elements.
Additionally, if necessary we help with the assessment of Notified Bodies in an early stage. Some Notified Bodies are under pressure and are unlikely to get a new designation for the MDR or need to reduce their scope. If this happens, it will force manufacturers to transfer their CE certificates to another Notified Body. Many Notified Bodies, however, are critical in accepting transfers and have long waiting lists (up to 12 months or longer).
We will regularly interview one of our consultants about the EU-MDR. Next time Inette will share with us the opportunities of the EU MDR (read interview). If you have a specific question you want an answer on EU-MDR, send a mail to firstname.lastname@example.org and we will try to get your question answered in one of the upcoming interviews.
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