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.