Moving on to the requirements for your authorized representative. These are fewer, but nonetheless important. Legal manufacturers are expected to essentially designate their ARs, as well as to agree upon a mandate of their responsibilities with their authorized representatives.
They are expected to ensure the authorized representatives have permanent access to all documentation required to fulfill their tasks. They also must define the modalities in their agreement between the manufacturer and both the incoming & outgoing authorized representatives (in the event of a changeover for authorized representation).
Suffice it to say, these have all been a specific focus in a lot of discussions, particularly the availability of permanent access to documentation since legal manufacturers regard this as intellectual property and proprietary under many circumstances.
Many legal manufacturers are currently negotiating with their notified bodies about whether they can provide access to redacted copies, or copies of technical documentation that would be sufficient to fulfill all the required tasks, but would not give a technical documentation availability to the full suite of intellectual property from the manufacturer.
This is the time for you to be considering the agreements that you’re going to be making with your authorized representative.
Now, the person responsible for regulatory compliance is a new role identified by the EU MDR. It is the responsibility of large and medium manufacturers to appoint a person in their organization as the person responsible for regulatory compliance, and they must have demonstrated expertise. It essentially comes down to education and training.
Manufacturers that are smaller, including small and micro manufacturers, have the option to use an outside resource to designate a person responsible for regulatory compliance. On that note, please be aware that changes in your person responsible for regulatory compliance will be regarded as a significant change by your notified body.
As such, you may want to think carefully about the benefits and risks of having a third party nominee for your PRRC, especially if it means you’re going to have that person changing over the course of the next many years. Each personnel change will be processed with a significant change now. This requirement for your PRRC’s registration is expected to be completed by the date of applicability on May 26th of next year.
We now know that the registration elements will be available in late 2020. So, we will have months to do this in advance of deadlines. You should expect to be done with this step of registration for your authorized representatives, and your person responsible for regulatory compliance, by the day that you have determined with your notified body for your manufacturers MDR certification audit.
This brings us full circle. We’ve had time to discuss many topics today, and as time permits, we’ll have a few minutes now to talk about a couple of the modules that we didn’t discuss, including article 57, the electronic system on certificates, and article 73, the electronic system on clinical performance investigation.
As we discussed previously, this first article is the electronic system on certificates. That is article 57, and article 52 in the IVDR, which describes the requirements. That is where you’re going to find your certificates for your declarations of conformity and summaries of safety and clinical performance. There will also be a part of that module that will contain the current list of designated notified bodies and how they are designated for each regulation.
That brings us to the electronic system on clinical and performance investigation. This is where the two regulations diverge a little, in regards to the MDR, it’s called clinical investigations, and in the IVDR, they are called performance investigations. These are under article 73 of the MDR, and article 68 under the IVDR. Nonetheless, this is the module where you are going to log on to get a single identification number, if you’re performing either clinical, or performance investigations in the EU.
That is going to be a go-to resource for those of you in that situation. These two modules are not expected to be available by the date of applicability. We currently are keeping a close eye on when they may be made available, as there are certainly many development projects that are ongoing, and will be depending upon this type of functionality.
Celegence can be a very useful resource for you to continue to stay up to date, and to help navigate through this path as you are moving forward in the next many months towards compliance.
So, this brings us full circle. Today we discussed many topics including EUDAMED and UDI. Thank you!