Moving on, we have the electronic system on market surveillance. This is your article 100 obligation, correlated to the article 95 from the in-vitro diagnostic regulation. This is where you will find your final inspection reports for all economic operators in the supply chain, information on non-compliant products, and information on products that have unacceptable risks to health and safety.
Moving along to the final position, we have the electronic system on clinical investigations. This is the article 73 obligation, and it is correlated with article 69 in the in-vitro diagnostic regulation, where it is called the electronics on performance investigations. This is a module that the legal manufacturer will use if performing clinical or performance investigations in the EU, and this module will generate single identification numbers for clinical investigations. Most of the information that is on this module will not be available to the public.
Now, if we move to the right, we have considered most of these document oriented elements, and to the left, we also have registration requirements, which are shown here. This is a group of modules that will include the registration of economic operators, which is article 31 in the MDR article, and article 28 in the IVDR. It will also include the registration of devices, which is article 29 in EU MDR, and article 26 in the IVDR, as well as the BUDI database, which is article 27 in the MDR, and article 24 in the IVDR.
These modules for registration are said to be slated for availability in late 2020, which should give us about five months in advance for compliance with registration requirements for EUDAMED in advance of that date of applicability in May of 2021.