On the other hand, here you see how these different activities are embedded in each other. This is for the planning stage where you have the clinical evaluation plan, and within that, you have the PMS plan. And as a part of that, you have the post market clinical follow-up plan. All these things need to be laid out in your system. These processes have to be established in your quality system so that you have a systematic approach on how this planning is done, and later, can execute it.
Once you come to the reporting part, here we have the post market clinical follow up report, so that it meets to match whatever you have planned before.
It is part of the clinical evaluation report that is regularly updated. And all of that is part of the technical documentation, including the risk management and some copies of the instructions for use. So, all these documents and processes are linked to each other and it is important that you implement that structure in this way. In the end, that means with the PMCF report and the clinical evaluation report, you have to update the technical documentation.
Here you see an overview for how the plans of the different aspects refer, or relate, to the reports or the summaries given. You can see again that the summary of the safety and clinical performance is the central part where you aggregate all the information on the post market surveillance process. And again, make sure that this is in place even for existing MDD certificates of products.
So now the second aspect I want to highlight here are the economic operators. Before we go into the different roles here, it’s important to understand that these terminologies are used for the European market, which is ‘placing on the market’ and ‘making available.’
- Placing on the market – Placing on the market is the first transfer of the device from a manufacturing stage into the European Union.
- Making available – is really the distribution to the end user of the device, whoever that is.
Now looking at the economic operator activities and the obligation, we started with a manufacturer – if the manufacturer is on European territory, more precisely, the territory of the European Union, then the manufacturer places those devices on the market by themselves.
But if not, they will have to have an authorized representative for doing that. And if the devices are shipped from outside the European Union into the European Union, that is done by a so-called importer. So, in that case, the importer takes on the role of placing the devices on the market. There is another role that can be the same entity, but does not have to be, and that is the distributor. The distributor, according to our definition, makes the devices available on the market. With these roles, there are different obligations they are following and different things to consider here. So here, you see the overview of what the economic operators from the authorised representative, the importer, and the distributor are supposed to do, and for what parts of the device information they are responsible for.
Now, what is really important and a significant change to the previous set up under MDD, where you had this European representative in a slightly different matter, is that there are legal responsibilities on each of these economic operators. The distributor is obliged to verify the CE marking and the declaration of conformity (DoC), the instructions for use, and the UDI. The importer needs to verify it again, this is the CE marking, the DoC, labeling, and the UDI, and these are legal requirements.
Authorised Representative – also, the authorised representative is legally responsible for the product on the market in Europe. So that is important also for your business relationship with these economic operators.
One of the things we also have to consider here, is that Authorized representative is supposed to have a person in place that is responsible for regulatory compliance. The way the different tasks are split between the manufacturer itself, and the European representative, you can see here. The basic check of the device, and the conformity before the release of the device, is on the manufacturer, as well as the technical documentation and issuing the declaration of conformity. But the European representative is supposed to carry out the post market surveillance, the vigilance reporting, and the device statements for international performance studies. Additionally, it’s important to mention that the technical documentation has to be available with the EU representative at any time. That’s also a change to the previous set up under MDD, where the E.U. representatives would just have to make access to the technical documentation available. Here, the technical documentation needs to be available with the European representative, so, that also means your European representative will have access to the technical documentation in full.
In conclusion, regarding your planning of the remaining year, coordinate resource planning with your notified body, and prioritize your projects strategically because the resources will be limited. Prepare postmarket activities for the complete product portfolio, MDD and MDR, because the respective MDR requirements also apply for maintained MDD certificates. Establish the PMS in your systems and your documentation. Make sure that all the updates and reporting is in place for all the post market activities. Take a close look at the setup of your economic operators and their legal obligations. Make sure that the economic operators you have in place are ready and prepared to take on the roles and responsibilities they have under MDR. And then lastly, ensure each of the European economic operators is clear about their obligations and duties, including legal responsibility. And with that, I would conclude my brief overview of what to consider in this additional year before the date of application of MDR. Thank you very much!