As we are ready to start the summer holiday in the EU, I want to take the opportunity in this blog to look ahead at the impacts of 2020 and what we need to prepare ourselves for. The MedTech sector awaits another year full of challenges and adjustment, especially considering the dynamic regulatory environment in Europe. But also, global developments will potentially reshape the way businesses in the MedTech sector need to deal with expectations, processes, and requirements in the quality, regulatory and clinical space.
At Qserve, we have just completed our Global Annual Meeting, where our teams from the US, Europe and China have come together at headquarters in The Netherlands for 3 days to kick-off 2019/2020 as a global team, to share experiences from recent compliance projects and the changing expectations of Notified Bodies, to discuss best practices of the EU-MDR implementation projects, and the latest interpretations around performing clinical evaluations, PMS and setting up PMCF studies, among others. In this time frame where the worldwide regulatory environment is changing drastically, it is important that we share our experience from client projects globally and continuously upgrade our knowledge to keep up with the ever-increasing complexity in regulations and technology around the globe.
Before looking ahead, we can learn from several developments and trends in 2019, which help us predict what we need to prepare ourselves for in 2020. Looking at the projects Qserve consultants have engaged in the past 12 months, the following trends become apparent:
- The Notified Body landscape has been changing as predicted earlier. We see that Notified Bodies are presorting for the MDR, both in audits and tech reviews. All Notified Bodies have become tougher in their QMS audits and dossier assessments resulting in more nonconformities of which more majors. Evidence-based data both pre-clinical and clinical are required and promised PMCF data must be delivered upon renewal of MDD certificates that need to be in place for the grace period. More detailed correlation is expected in the technical dossiers between what manufacturers claim in their labeling and IFU versus what can be found in the risk management report, clinical evaluation report and design verification and validation reports. The QMS audits go deeper in following trails in the documentation and requiring evidence through records, leading to more nonconformities.
- The Notified Bodies struggle with capacity. The average waiting time for manufacturers for technical reviews is between 12 and 18 months, and the reviews typically take longer to finish due to the enhanced expectations that are currently in between old and new regulations.
- The Notified Bodies are only exceptionally accepting new applications or transfers from other Notified Bodies.
- The Notified Bodies are using all their capacity for the re-certification to MDD. Most manufacturers do have for their portfolio or part of their portfolio a request to have another CE certificate under the MDD that will last as long as possible until May 2024.
A huge number of manufacturers does not know, or at least are in denial phase, that during the transition time of the MDD certificates (until May 2024), it is not allowed to make any changes. Manufacturers are in denial because the standpoints from the Notified Bodies appear to vary. The text in the MDR (Article 120 (3)) mentions ‘…,provided there are no significant changes in the design and intended purpose’. We believe that certainly, all changes that need a change in the certificate will not be possible in the transition period. That implicates that changes in scope, address, name, etc. are not possible and will initiate a new review against MDR. Some Notified Bodies have already written guidance on ‘changes’. Our advice is that you have a detailed RA/QA plan for each device (product family), mapping out the changes that are planned over the years that this device is certified under the MDD CE certificate. These changes can be discussed with your Notified Body. The result is that you will have to start preparing MDR files for those devices/families that have planned changes that will not be accepted by the Notified Bodies under your MDD certification. Please take our advice to discuss this with all departments within your company. It can certainly influence the plans for the design department or marketing. Keep in mind that by May 2024 (or the earlier as your end date on the certificate dictates) all devices need to comply with the MDR, and need to be approved by the Notified Body, so planning here is of importance as well.
The increased push on evidence-based clinical data and more scrutiny toward clinical indications are leading to more PMCF studies being developed. Qserve’s CRO team is busier than ever with developing the optimal clinical strategies with a practical approach, designing clinical protocols for PMCF studies and managing trials.
- The number of manufacturers reaching out to us with problems, suspension of certification, need for rapid transfer, or enhanced scrutiny on reported vigilance cases and potential recalls are increasing.
- At the same time, especially large multinationals have started with planning their EU-MDR implementation: we help them doing gap assessments on their QMS and technical dossiers, look at rationalization of their product portfolio and determining an impact analysis to set up the implementation plan. The year 2024 seems far away but is around the corner if you look at what needs to be done.
- Due to the MDR, start-up companies are shifting the regulatory strategy. For most of the companies, it was normal to start working on EU market access and gather data from the European market to bring the device to the US market. We do see nowadays that manufacturers tend to start with focusing on US market access and in the second phase intend to work on the EU market access. This trend is also seen with companies in Asia, they tend to wait with introductions to Europe until the MDR is sorted out while in the meantime focus on US market access or the domestic market (China, Japan).
- For the IVDR, we should not forget this regulation as the impact on manufacturers are drastic, the transition period ends 2 years later than MDR (May 2022). It is obvious that all parties involved learn from earlier assessment and implementations in MDR. Qserve hired Sue Spencer, the leading expert for IVD and IVDR. (See the announcement from 17th of June 2019.)
- At the same time, China is stepping up requirements for market access China, and also for being China agent. We do see multinationals with legal entities in China changing the China Agent to an independent company (like Qserve) to have more control over local RA.
How should we prepare for the drastic changes in our regulatory field?
After all, these changes can be overcome by communication alongside a clear strategy, as we are all in a grey phase since there are many unknowns yet with regard to Notified Bodies and how they will audit against the MDR. Talking to your peers will help you understand the position of Notified Bodies and competent authority. Events like RAPS conferences, especially the local chapters, are ideal to keep up to date with the latest developments while meeting your peers. Qserve also organizes once a year a conference highlighting the latest developments. This is focused not only on the MDR, but it is also a more holistic approach, looking at all changes worldwide and how that affects the overall strategy of manufacturers. For more info see 4th Qserve MedTech Conference.
What we did not discuss yet are the ongoing topics like Notified Body designation process, the Brexit, and MDSAP. We will prepare separate blogs on these topics. From August we will also plan a series of blogs on the IVDR, written by Sue Spencer as she joins Qserve as head of IVD.
Have a great summer!