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.
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.
A review of prior guidance around this topic revealed that the Competent Authorities for Medical Devices (CAMD) frequently asked questions (FAQ) does attempt to clarify what is included in Article 123, specifically those items listed in section (3)(d). The document outlines that the intent of this section is only to delay the electronic storage of documentation and does not include a delay in the preparation of the reports referenced.
The document does, however, have a disclaimer that additional guidance may be required for practical implementation of this section of the regulation. Since this FAQ was originally issued, MDCG 2019-4 Timelines for registration of device data elements in EUDAMED has since been issued to offer clarification on the interpretation of the regulation related to registration.
While the delay in EUDAMED certainly helps give us more time before we must submit information to the database including registrations, vigilance reports, clinical investigation information, PSURs, and SSCPs, it does not change the implementation dates for these activities.
R&Q will continue to monitor for the rumored corrigenda that could provide some additional relief, but at this time that is still a rumor. We recommend continuing with your current EU MDR transition plan and to not let the EUDAMED delay keep you from staying ahead of the implementation timeline. If you get stuck, reach out to the R&Q team to find out how we can help.
Looking for more EU MDR resources? Say hello to your expert implementers:
- On-Demand Webinar: Solving the EU MDR Labeling Puzzle
- Link to EU MDR Frequently Asked Questions
1) European database on medical devices (EUDAMED). European Commission. https://ec.europa.eu/growth/sectors/medical-devices/new-regulations/eudamed_en. Accessed November 19, 2019.
2) FAQ - MDR Transitional provisions. CAMD Transition Sub Group. Competent Authorities for Medical Devices. https://www.camd-europe.eu/wp-content/uploads/2018/05/FAQ_MDR_180117_V1.0-1.pdf. Published January 17, 2018. Accessed November 19, 2019.
3) MDCG 2019-4 Timelines for Registration of Device Data Elements in EUDAMED.; 2019:1-2. https://ec.europa.eu/docsroom/documents/34921. Accessed November 19, 2019.