Medtech Insight: global medical technology news & analysis
01 Jul 2020
No device-related warning letters were released by the US FDA the week of 1 July.
The EU’s joint action on market surveillance, now a focus after the success of the joint action on notified bodies, is focusing on cooperation and avoiding duplication, rather than a step change, to achieve a safe EU. But it is early days and the key changes that will ultimately impact manufacturers will be announced further down the line.
John Wilkinson, head of devices at the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), does not anticipate any seismic changes in the way market surveillance is carried out in the EU as a result of the launch of the new competent authority joint action market surveillance initiative.
“I foresee a continuing evolution of the management of the system”, he told Medtech Insight during a recent interview.
So it looks like this initiative's impact will not be as far-reaching and revolutionary as that of the joint plan for immediate action which came about following the PIP breast implant crisis and which led to joint audits and unannounced visits for notified bodies and regulators
“I don’t think anybody should be fearful of this initiative,” he said. “For me, it is designed so you get consistent responses from the [market surveillance] system - which has not always been the case. And it’s also very much designed to increase efficiency and effectiveness, reduce duplication and increase collaboration.”
In response to the question of whether there would be more product-targeted market surveillance, Wilkinson said this was some way down the line, following development of the structures on which the market surveillance program is created. But he emphasized that whatever comes out of this latest joint action program needs to be proportionate and risk-based, repeating the MHRA’s medtech regulation mantra which has generally been acknowledged to serve the EU well.
“It is entirely conceivable that there will be more coordinated activity and more targeted activity, which in itself might be much more effective. Whether there is going to be a step-change in terms of the amount of activity going on, I don’t know, he said. I think its effectiveness is likely to be substantially increased because basically the network if going to be targeting particular activities rather than particular competent authorities doing their own bit in isolation”.
So how will the new initiative work, how is it be funded and what will it entail for the authorities and their future? Medtech Insight invited Wilkinson to share his knowledge and views:
Medtech Insight: What funding has there been for the latest initiative? How much is Chafea funding and how much is coming from other sources?
John Wilkinson: The European Commission’s Consumer, Health, Agriculture and Food Executive Agency (Chafea) is providing €850,000 worth of funding to the market surveillance project. This represents some 60% of the overall cost of the project. The assumption is that the remaining 40% will be provided by competent authorities around Europe in terms of their time, energy and sometimes specific costs.
To gain this funding, the Competent Authorities for Medical Devices group had to put together detailed plans. So there are contractual obligations between Chafea and the UK’s MHRA which administers the whole project. There are also contracts between the MHRA and the two types of participants in the project: beneficiaries and collaborative stakeholders. Beneficiaries receive money for participating while collaborative stakeholders can participate but do not receive funding for this.
To what degree does this work go beyond the normal day-to-day activities of competent authorities?
Wilkinson: While much of this work is consistent with the work we are doing anyway to implement the current and anticipate the new regulations, and in the same direction of travel, what this new initiative does is to create very specific projects that build on the other issues we need to tackle. We are moving the level of collaboration and the tools that we have at our disposal forward in a way that would not be achievable during normal routine work.
There is a big difference in the resources available within the different competent authorities. Do you expect each competent authority to pull its weight, for example by employing more people or are you looking at the bigger authorities taking on more of the workload?
Wilkinson: I think the aggregate amount of energy going into this may not change. The important thing is - and I can’t speak for the amount of resources that are going to be available across the system to do this, but what we can commit to is making sure that the resources that are there are utilized in a more efficient way. Inevitably there will be a difference in the contributions of the very large member states versus those of the small ones. If we get the collaboration right – and there is a huge range between those countries involved in the joint action – I think the smaller MS with limited resources can contribute but in a more selective way that reflects the availability of their resources and skills. We have seen some very good work and interventions by individuals in quite small member states. That is to be lauded. But you cannot expect a very small member state to maintain the volume of activity that France and Germany can do.
Where does the joint action activity that has been focusing on instructions for use (IFU) fit in, among other things?
Wilkinson: The Austrian-led joint action on IFU was initiated as part of a desire to do more joint action activity and was something of a pilot for this bigger joint action on market surveillance. But, from the Chafea point of view, each of these are discrete exercises.
This more recent joint action that has been launched is not really connected to the one on IFU.
The latest joint action initiative seems more structural than actually focused on product areas. At what stage will you decide on the product areas to focus on and how soon? Do you have any idea yet of what the priority product areas are likely to be?
Wilkinson: There are five work packages, and three of those, which the UK is leading, relate to the running of a joint action program: coordination; dissemination and evaluation.
Then there are the two substantive parts – one is on manufacturer inspections, and the other on clinical process and resource development. In both these cases, the aim will be to develop horizontal methodologies for dealing with market surveillance issues. This may lead to identifying some product-related priority areas.
The manufacturers inspections action will be about evaluating and setting criteria for the competent authority role inspections.
Ultimately, the aim will be to create methodologies and tools which can be used as basis for future work. I think pinpointing actual product areas will be well down the timeline and be the logical product of this exercise. I don’t think we can expect anything at the front end.
The joint action in the notified body area resulted in the Recommendation and Implementing Regulation of Sept 2013. Do you think there will be new documents to be drafted for the market surveillance initiatives? What sort of documents would they be?
Wilkinson: There is likely to be a mixture of documents that are tools for competent authorities to use and that will not be in the public domain, and then others that will be of more general utility and help people ensure they are compliant with the requirements.
The sort of documentation that will come out will deal with inspections of manufacturers, and clinical processes, for example. There may also be some detailed guidances in this area.
If the IFU project was the first pilot, a second project had been anticipated with a series of follow-on programs - development of software to help system function; development of guidance; shared training and development of people; execution of specific sectoral MS programs targeting specific products and product types. What has happened to this project?
Wilkinson: The initial scoping discussions for this second joint action were quite broad. But we decided to get more focused experience first and not over-challenge the network. We have decided to take cautious steps and develop our learning in limited areas. The areas in which we are working are important ones and could potentially expand.
Is this proactive type of market surveillance likely to interrupt to some degree the open communication that currently exists in many EU countries, and especially the UK, between the regulators and the industry, as individuals have to assume the role of policing and being policed?
Wilkinson: I don’t think you should necessarily see this as increased market surveillance. You should think of it as harmonizing the approach and being more efficient about the way we do it as we are sharing resources. It is about rationalizing and coordinating different approaches - in a way it is a logical extension to the competent authorities’ joint audit activity. It is also about manufacturers being able to expect a similar approach wherever they sit in the system and the system doing it efficiently so we are not tripping over each other and duplicating each other’s efforts.
Three of the working groups are being led by the UK and the UK is also leading the CAMD task force for exploring opportunities for collaboration in implementing the new Regulations. This may seem surprising to some in light of the Brexit vote, even if the UK hasn’t actually left the EU yet. What is the strategic reason for having the UK so active in this?
Wilkinson: The market surveillance joint action activity predates the referendum by some considerable amount of time. Also, we take the view that we will continue to do what we can to reinforce the European system which we are still part of until we know otherwise.
Having spent so much time negotiating the new legislation, we believe it is in the interest of the manufactures, and indeed patients and clinicians in the UK, that we participate in making sure that those things that we negotiated are faithfully implemented. That doesn’t prejudge any Brexit outcome. If you are a manufacturer in UK, you are going to be working in Europe in all likelihood and so it is in the interests of everyone that that legislation is sensibly implemented.
When it comes to the market surveillance initiative, we are carrying out the compulsory administrative packages associated with the joint action. The Netherlands and Ireland are leading the substantive work.
How will the CAMD fit with the new Medical Devices Coordination Group?
Wilkinson: The full implications of this question and who does what is still very much to be decided. There is a very real question mark about how the new working group governance architecture evolves, and how the working groups are going to function. Quite a lot of dialogue needs to take place before all that architecture is up and running.
One of CAMD’s priorities when it comes to implementation of the new regulations is making sure that the new workings groups support the MDCG and that the MDCG functions effectively. CAMD is very actively involved in those discussions since ultimately the running of the system is the joint responsibility of the authorities and the Commission.
In the past, there have been specific CAMD-led activities and Commission-led working groups. We are looking towards a future where the structure in which these working groups operate is becoming less material than the content of the work that they are doing
From the editors of Clinica.
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