Interesting developments after the joint plan for action that Commissioner Dalli sent to the member states in the beginning of February this year urging them to step up market surveillance in order to safeguard the credibility of the EU medical devices vigilance system (which are conveniently summarised in his speech of 9 Febuary 2012): the Dutch minister of Health sent a public reply to the European Commission detailing what the Dutch government thinks should be done to make the system more effective and what the Dutch are willing to do.
The reply is noteworthy for a number of reasons. First of all, it addresses points that the Commission did not (explicitly) address in its letters to the member states about the joint action plan. Secondly, it gives an insight into what member states think is feasible and what should go into the Review. Feasibility is an important point here. I recently sat down with one of the vice presidents of regulatory of one of the biggest devices companies in the world and we calculated that under present circumstances EU member states devote about roughly a 100 times more resources to medical products oversight than to medical devices oversight. In other words: commit peanuts and, well, let’s say you don’t achieve an optimal result. Everyone can be outraged about scandals all they want, but this is where it all starts and ends; just like it did with medicinal products and their regulation that is touted to be the solution for all the problems of medical devices oversight by HCPs. Sure, if member states are willing to increase their medical devices oversight budgets by a factor 100 important improvements can be made easily.
So, what do the Dutch propose? Not factor 100 increase of budget, that is certain because no member state (nor the Commission) can afford that at the moment. They do propose some other things, some of which controversial but effective.
- Coordination. With regard to the further elaboration of some of the actions, the Dutch minister stresses the importance of Member States to act jointly and in a coordinated manner while implementing the proposed actions and adds that the Central Management Committee (CMC) could be of great added value in this process.
- Notified bodies. Dalli’s letter requested member states to critically review notified bodies and their accreditation, joint inspection teams were coined internally as possiblity and have found their way to the Review proposal. The Dutch add that ‘Joint Inspection Teams’ of Competent Authorities (CA’s) should be composed of inspectors of at least two member states. Inspections of Notified Bodies should take place partly unannounced. Nothing new so far but here it comes: “It is also crucial that inspection reports are written in English and filed in an EU-database, which has to be accessible to every Competent Authority.” The part on language is new and politically controversial as language always is. It goes without saying that using one language for reports or for that matter inter-authority communication has immense benefits. Different languages are provide cultural diversity but not effective communication if you want an integrated pan-EU market surveillance capability. Not that many member states will want to allow reporting to happen in another language than their own. The Dutch are less concerned about that, which makes them an excellent party to get the ball rolling here. It would be an immense benefit if authorities were to think beyond their immediate borders and use one language for this, and I personally don’t really care that much if that’s English, French or German. It would make things much easier.
- Market surveillance. Commissioner Dalli’s plan already requested that Competent Authorities should focus on manufacturing companies as a whole in their market surveillance (the action plan already indicates the need for inspection by the notified body of the specific product which is being assessed). Manufacturing companies that operate internationally should be inspected by Joint Inspection teams of at least two member states. New is the Dutch idea to organise EU coordinated market surveillance according to the complete life cycle of specific ‘product lines’. That would mean (I think) that the focus of supervision would be directed to the phases of the life cycle of device group and associated surveillance needs. For example, the most incidents tend to happen when a new group of devices hits the market. It will still need to become clear what this will look like exactly, but the fact that the Dutch government is talking about this publicly I think means that they are pushing to have this included in the Review. Also in respect of market surveillance the Dutch emphasize the need of inspection reports by the Competent Authorities and the audit reports from Notified Bodies to be written in English and accessible to Competent Authorities in an EU-database.
- Registration of implants and its complications. Registration of implants and the registration of adverse events are essential to effective market surveillance including the detection of long-term implications and taking effective corrective actions at European level in case of serious incidents. The Dutch underlines that it is necessary to involve health care professionals and end-users, which is entirely true. In my practice I find time and time again that vigilance efforts are less than effective because HCPs are not that enthusiastic about cooperation for vigilance purposes for a multitude of reasons. At short notice the Netherlands intends to set up a working group to investigate the possibilities of such a registration in the Netherlands. The working group will also take into account other existing initiatives in the EU, which the Dutch hope will contribute to a European registration, of which we know that it will be included in the Review as the Commission is planning EU UDI for devices.
- Stricter Post Market Surveillance (PMS)- obligations of the manufacturer. The Dutch minister says that current Post Market Surveillance obligations could be stricter; manufacturers could be obliged in a stricter way to notify Vigilance reports to Notified Bodies directly and that Post Market Surveillance activities and frequent reports to the Competent Authority should be a specific obligation as part of audits of manufacturers by Notified Bodies. The latter is fleshed out in more detail in the new MEDDEV on PMCF that I wrote about on this blog. As I predicted, this MEDDEV is a prelude to obligations that will become mandatory in the Review. Vigilance reporting to notified bodies is currently an internal contractual issues between the notified body and the manufacturer and I see notified bodies deal with this in varying degrees of diligence. Standardised rules on vigilance reporting to the notified bodies would in my view improve supervision, but they would on the other hand require a less cyclical (and more continuous) process at notified bodies, which not all of them will be able to facilitate. This should be firmer part of the accreditation requirements, which Commissioner Dalli has requested the member states to review.
So let’s see how this progresses – it does provide some insight where things are going and what the Review may look like in the proposed version that is still slated to come out June 2012, even if many doubt that. If readers of this blog are aware of reactions of other EU member states to the joint plan of Commissioner Dalli, I would be very interested in hearing about them.