As we have come back from our Christmas break and started our work in the new year again, I want to take the opportunity in this blog to look ahead at what 2018 might bring us 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 outside Europe 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.
Qserve Group
At Qserve, we have just completed our Global Annual Meeting, where our teams from the US, Europe and China have come together in The Netherlands for 3 days to kick-off 2018 as a global team, share experiences from recent compliance projects and the changing expectations of Notified Bodies, the first 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 external regulatory environment around us 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 worldwide.
Before looking ahead, we can learn from several developments and trends in 2017
Which help us predict what we need to prepare ourselves for in 2018. Looking at the projects Qserve consultants have engaged in the past year, the following trends become apparent:
Notified Bodies:
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The Notified Body landscape has been changing as predicted earlier. 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. 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 documentation and requiring evidence through records, leading to more nonconformities.
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The Notified Bodies struggle more with their service level caused by the difficulty to find experienced staff. Even when assessors with the right background are found, it takes about 2 years to gain enough experience in doing effective assessments without just following checklists. Assessments take more time and there are several Notified Bodies that have confirmed they do not accept new applications any more for certain product scopes or not at all as they have difficulty already serving their existing customers.
Clinical Evidence
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The increased push on evidence-based clinical data and more scrutiny toward clinical indications
is 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.
CE Certificate (EU-MDR)
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The number of manufacturers reaching out to us with problems, suspension of certification, is increasing.
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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 2020 seems far away but is around the corner if you look at what needs to be done.
ISO 13485:2016•
And in all of this, we almost would forget that upgrade certification to ISO 13485:2016 needs to take place this year,
before March 2019. With many of our clients, we look at gaps, help upgrade their quality system to prepare for the upcoming upgrade audit from their registrar. As the new standard is mostly about integrating US QSR elements that were not covered in ISO 13485:2003 yet, as well as introducing the risk approach to processes, it is in the first place a challenge for those manufacturers who do not have devices on the US market.
How should we extrapolate these trends into 2018?
Below are my expectations based on what we have seen at our customers the past year.
Notified Bodies
The pressure on Notified Bodies will continue. They all have several challenges, which will affect their service and attitude toward manufacturers.
• The number of Notified Bodies continues to drop (so far from 85 to 59 for MDD – 14 for AIMD and 22 for IVDD), which means their customers need to find an alternative Notified Body. That will increase the pressure on the remaining ones. As indicated, not all of them accept new applications now.
• The Joint Assessment Team (JAT) audits from authorities continue putting ongoing pressure on Notified Bodies to increase their scrutiny upon manufacturers.
• The process of application for designation under the new MDR and IVDR started in December last year, the first Notified Bodies have submitted their application. They will receive designation audits, the preparation, and hosting of which will consume time from their senior staff.
• They will continue to seek additional staff that required training and qualification.
All together they will have to devote more time internally that they cannot spend on their customers. Most of them have not prepared for this sufficiently in terms of adequate resources, updated processes, and training of their staff and will be challenged to keep their service level up, specifically with regards to approving new products or significant changes.
ISO 13485:2016
This will be the year in which most manufacturers will undergo their upgrade audit to ISO 13485:2016. This is expected to be a relatively predictable process, but will certainly consume additional resources from all stakeholders: manufacturers, Notified Bodies, consultants.
EU-MDR
More medical device manufacturers will slowly start with becoming aware of the impact of the MDR, and starting to prepare for it. The larger multinationals who started last year are now getting into the phase of determining additional resources, asking their management for additional budget and start execution of plans. However, the vast majority has not even started or only just got their head around it, trying to determine what it means for them and trying to convince their top management this is something substantial with business impact. The biggest challenge for all of us in this regard is to find enough qualified resource in time.
EU-IVD
Manufacturers of in-vitro diagnostic medical devices have been slower to look at the impact for them of the EU IVD regulation. Probably because the transition time is longer with 5 years compared to the MDR, but also because most attention so far has been given to the MDR. This will change through this year. Five years may seem a long time, but the significance of the new regulation for IVD manufacturers is much bigger.
Clinical Evidence
The focus on clinical evidence will continue and be seen through more clinical (PMCF) trials being started and companies seeking capacity to upgrade their clinical evaluation reports. To support this significant shift in expectations, we are giving more and more in-house training at our clients to increase the internal competence of manufacturers.
The number of suspensions of certifications will continue probably at the same pace as the past year. The overall level of compliance will have to go up for everybody, with much more detailed expectations to have evidence in data to support claims, evidence through records of the QMS, correlations between all aspects of the quality system, verification and validation reports and risk management reports. And the scientific level of test and study reports will need to go up. This will require more academically trained staff at manufacturers, who can deal with this level of complexity. Manufacturers will have to look critically at where to invest to achieve the required compliance level and which products to phase out the coming years.
I have not addressed two interesting topics, on which we will see more clarity this year: Brexit and MDSAP.
Brexit
For the British Notified Bodies (5 under the MDD, 4 under the IVDD and 1 under the AIMD) and their clients, these are uncertain times. The European Commission has issued a notice on 22 January 2018 making clear that after 30 March 2019, existing CE certificates from UK Notified Bodies are no longer valid in the union, unless an agreement is reached before that time. Some of the UK Notified Bodies have anticipated and are working on backup scenarios through having Notified Bodies on the European continent. But much is unclear still: will this be needed or is an agreement reached before April 2019? Will manufacturers of those Notified Bodies need to change their labeling and associated documentation when they would get a certificate with a new NB number? What is the impact of new CE certificates on global registrations for manufacturers? Will the stakeholders associated with such a transition in a very short period of time be able to handle the volume for all manufacturers involved or will queues develop? What will be the impact on ongoing change requests? Most of these questions cannot be answered at this time.
MDSAP
And finally, the MDSAP program is slowly developing amidst all these changes. A number of mostly EU Notified Bodies have achieved the status of Auditing Organization (AO) under this program and are actively auditing manufacturers who request an MDSAP audit. This is a new experience for all involved. At Qserve we provide training and mock audits at our clients to prepare for this. The main driver for this program is still Health Canada who continues to prepare for the deadline of January 1st, 2019 to accept only MDSAP certificates for registrations of medical devices in Canada. I am still expecting though that many small manufacturers, especially in Europe will drop their license for Canada as the audit burden under MDSAP is too high compared to the current CMDCAS requirements, making it not a viable business case anymore. The authorities behind the MDSAP program have addressed this concern by allowing reduced audit time for smaller manufacturers, but it is still a significant increase for many. We are getting feedback from several of our customers that they are awaiting a proposal from their Notified Body / Auditing Organization for the transition to MDSAP already for over 6 months. So also here, capacity issues might arise in 2018.
Overall, 2018 will be an interesting year for the medical device and IVD sector. As a regulatory, clinical and quality community we will have our hands full to follow the many changes and assess how they will impact our companies, stay in compliance, and get the product to market effectively.
In my next blog, I will go into more detail on how to prepare and navigate best through this minefield.
Kind regards,
Jan
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