7 December 2020 Update: After some delays the first module of the European database on medical devices (EUDAMED) is live! Here is what you need to know about the Actor registration module, the first of six modules in EUDAMED: WHO can use this module? Economic operators (manufacturers, authorized representatives, importers, system procedure pack manufacturers) can now register. Note: United Kingdom (UK), Turkey, and Switzerland cannot yet. WHAT can they do? Obtain Single Registration Number (SRN) WHY is this important? The SRN is required to appear on the Declaration of Conformities (DoCs) and numerous other documents affecting all classes of medical devices. WHEN can they do it? If the company is located outside the European Union (EU), the authorized representative must register first but registration is open. HOW do I get started? Find the instructions, FAQs, and various supporting information on the European Commission's website here. For R&Q clients that have been waiting to obtain their SRN to finalize their Summaries of Safety and Clinical Performance (SSCP), DoCs, and have TBDs in their technical documentation, this allows them to move forward. >> Access On-Demand Webinar: Economic Operators - Addressing the EU MDR and IVDR requirements Originally published 21 November 2019, updated to reflect new MDR date of application: The European database on medical devices (EUDAMED) has officially been delayed until May 26, 2022! Due to COVID-19 pandemic, the date of application of the MDR has been delayed to May 2021, though you don’t need us to remind you that is right around the corner! Fortunately, a potential delay in the database was anticipated and provisions for a delay are outlined in the regulation that can be found on the European Commission’s page on EUDAMED here. So, what does the EUDAMED delay mean? Article 123 (3)(d) lists all the derogations that occur with a delay in the database until six months after notice in the Official Journal of the European Union that the database is available. One caveat to that notice is that the sections that are delayed are those provisions “that relate to EUDAMED”, meaning that you will still need to create a Periodic Safety Update Reports (PSUR) per the EU MDR schedule even if it does not have to be uploaded into EUDAMED. The conclusion paragraph from the section on derogations points to provisions to take until EUDAMED becomes available in 2022. It points to the use of existing Medical Device Directive (MDD) communication methods and this works for registrations, clinical investigations, and vigilance reporting as those provisions are existing systems in the MDD. However, it leaves out how new requirements will be covered during the interim from the date of application of the regulation to the implementation of EUDAMED. There is no clarification offered for new elements such as the Safety and Clinical Performance Reports (SSCP) and the PSUR.