Quick Summary
The EU Medical Device Regulation (MDR) Date of Application (DoA) reshaped how manufacturers, importers, and authorized representatives place devices on the European market. This Q&A—drawn from USDM's EU MDR Date of Application Readiness webinar with Jay Crowley—answers the practical questions that come up most often: how to handle EUDAMED registration and Single Registration Numbers (SRNs) while the database is still voluntary, what legacy devices and Class I self-certified devices require, how to submit Periodic Safety Update Reports (PSURs) to your notified body, how the MD symbol and UDI identifiers work, and why ISO 13485:2016 is a prudent foundation for an MDR-ready quality management system.
The following questions were asked during the EU MDR Date of Application Readiness webinar presented by Jay Crowley, Vice President of Medical Device Solutions and Services at USDM.
Watch the on-demand webinar: EU MDR Date of Application Readiness
New to EU MDR readiness? The DoA means only MDR-compliant devices—including legacy devices under a signed MDR agreement—can be placed on the EU market. Registration, UDI, and quality system obligations all flow from that single principle, so map your obligations device class by device class before the EUDAMED modules come fully online.
EUDAMED, Actor Registration, and SRNs
Is Actor registration in EUDAMED still voluntary? If so, what does this mean for Importers?
Assuming the relevant Competent Authority (CA) is participating, Importers can register and obtain a Single Registration Number (SRN). However, this is not required until the European Database on Medical Devices (EUDAMED) is made fully functional and available.
Our AR has informed us that the German Competent Authority is not issuing SRNs as EUDAMED is still "voluntary." Do you see this being an issue when submitting to NBs for MDR CE certification?
No, this is not an issue as EUDAMED is still voluntary, as is generating SRNs. Other CAs are also not issuing SRNs.
Because EUDAMED is rolling out module by module, manufacturers need a defensible plan for capturing registration data now and reconciling it the moment the database becomes fully functional.
Authorized Representatives and Legacy Devices
What happens if the Authorized Representative (AR) has not completed their verification of information for legacy product registration by 26 May 2021?
Since only Medical Device Regulation (MDR)-compliant devices can be placed on the market after the Date of Application (DoA)—including Legacy devices—you must have a signed MDR agreement in place with your AR. However, these devices should not require a formal document review until they transition to an MDR CE certificate. This is not true for Class I self-certified devices, which will need to be MDR compliant by DoA, and will need to a reviewed by your AR.
If a Class III device (MDD) is not placed on the market, then is the BUDI and SRN not required at DoA but later once the legacy device is placed on the market?
A BUDI is never required for a Legacy device, but rather a EUDAMED-DI. Both will be required to register the device in EUDAMED, once available.
Is it true that we don't need to publish data for Legacy devices unless there is an adverse event?
No. Unless the Legacy device is replaced by a Regulation-compliant device by the submission deadline, the Legacy device will need to be registered in the EUDAMED.
PSURs and Notified Body Review
Our Periodic Safety Update Report (PSUR) drafts are prepared. The module in EUDAMED is not yet available. What is the next step relative to notified body (NB) review of these reports? Do we submit the PSURs to the NB directly?
Yes, for Class III and implantable devices, the PSUR is always submitted to the NB directly (in the case of EUDAMED unavailability), but check with your NB to determine how they want to receive it until EUDAMED is available.
How to Think About MDR Submission Timing
- Confirm device class and pathway. Class I self-certified, legacy, Class III, and implantable devices each carry different DoA obligations and review triggers.
- Lock in your AR agreement. A signed MDR agreement with your Authorized Representative is a prerequisite for placing any device—including legacy devices—on the market.
- Coordinate with your notified body early. While EUDAMED modules are unavailable, the NB defines how PSURs and other documentation are received.
- Stage your registration data. Capture BUDI/EUDAMED-DI and SRN information now so registration is fast once the database is fully functional.
The MD Symbol, UDI, and Identifiers
With respect to the MD symbol, there are two applications: one as "Medical Device," but on Patient Implant Cards, the MD symbol corresponds to the brand name. Why are there two meanings now?
Yes, that decision was made by the Medical Device Coordination Group (MDCG). In the MDCG 2019-8 v2 guidance document it states, “Please note that in the ISO context, the ‘MD’ symbol is used to identify that the product in question is a medical device. On the implant card, this symbol is used to indicate the device name.”
Can you elaborate on the newly proposed Master UDI-DI by the EU Commission?
It is too early in the process to go into much detail. All we know is that its purpose is to find a solution for grouping devices with many individual permutations (e.g., contact lenses) to reduce the number of records in EUDAMED. We also know that the Master UDI-DI will be a production identifier (PI) in the UDI. The Commission will need to publish an Implementing Act to add this new requirement.
Does the GS1 Global Model Number (GMN) and the Basic UDI-DI have any other useful purpose as we integrate it into our product? Would it benefit anyone to include for non CE-marked products?
There are other regulators considering the use of Basic UDI-DI (GS1’s GMN); however, at this point, only the EU is requiring its use.
UDI accuracy depends on trustworthy product records and consistent identifiers across systems, which is why data integrity is foundational to a sustainable MDR program.
Harmonized Standards and Conformity Assessment
Since it’s unlikely there will be harmonized standards for EU MDR available at the DoA, what affect does that have on the ability to use standards for conformity assessment?
That is up to your NB and whether they will allow you to apply them prior to harmonization (noting how differences between the requirements of directives and regulations have been taken into account). There has been progress in that CEN-Cenelec have agreed to revise the many existing standards listed under the directives and draft the required new standards for the new regulations.
Switzerland and Cross-Border Considerations
Is Switzerland still negotiating with the EU? We are an in-vitro diagnostic (IVD) manufacturer with DoA in May 2022.
Yes, they are still negotiating. Unfortunately, it is unclear how long it will take and if they will ultimately be successful.
Quality Management Systems and ISO 13485:2016
If I have a Class 1 registered FDA medical device that is sent to the importer in Germany and is not sterile, will I essentially need to be ISO 13485:2016 compliant? Is this assumption correct?
Regardless of the class, ISO 13485:2016 compliance is a prudent step. Though the standard is not (yet) harmonized with the MDR, many manufacturers use 13485 to help establish a quality management system (QMS) that meets the requirements of the MDR. Note that there are additional record keeping requirements stipulated in the MDR.
An MDR-ready QMS is easier to sustain when it is built on a validated, continuously compliant foundation. USDM's approach to Cloud Assurance and disciplined validation lifecycle management helps quality teams keep systems audit-ready as regulations evolve.
FAQ: EU MDR Date of Application Readiness
Is EUDAMED registration mandatory at the Date of Application?
No. While EUDAMED remains voluntary and is not yet fully functional, Actor registration and obtaining a Single Registration Number (SRN) are not required. Importers can register if their Competent Authority is participating, but registration becomes required once EUDAMED is fully functional and available.
Do legacy devices need a Basic UDI-DI (BUDI)?
A BUDI is never required for a legacy device; a EUDAMED-DI is used instead. Both the EUDAMED-DI and SRN will be required to register the device in EUDAMED once the database is available. Unless a legacy device is replaced by a Regulation-compliant device by the submission deadline, it must be registered in EUDAMED.
How should PSURs be submitted while EUDAMED is unavailable?
For Class III and implantable devices, the Periodic Safety Update Report (PSUR) is submitted to the notified body (NB) directly when EUDAMED is unavailable. Confirm with your NB how they want to receive it until the EUDAMED module is live.
Why does the MD symbol have two meanings?
Per MDCG 2019-8 v2 guidance, in the ISO context the "MD" symbol identifies that the product is a medical device, while on a Patient Implant Card the same symbol indicates the device name.
Do I need ISO 13485:2016 to place a device on the EU market?
ISO 13485:2016 is not yet harmonized with the MDR, but compliance is a prudent step regardless of device class. Many manufacturers use ISO 13485 to establish a quality management system that meets MDR requirements—while noting the MDR's additional record-keeping obligations.
Sneak Peeks
Here are a few clips from the webinar presented by Jay Crowley. Watch the full-length on-demand webinar EU MDR Date of Application Readiness. If you have more EU MDR questions or would like to speak with Jay directly, please contact us.
Additional EU MDR Resources
USDM EU MDR/IVDR Services
On-Demand Webinar: EU MDR Date of Application Readiness
Blog: More Medical Device Implications of Brexit
Case Study: Quality System Upgrade to Meet EU MDR and EU IVDR
Talk to USDM About Your EU MDR Program
Whether you are mapping legacy device transitions, preparing PSUR submissions, or building an MDR-ready quality management system, USDM's medical device specialists can help you get ready for the Date of Application and stay compliant as EUDAMED comes fully online. Contact us to start the conversation.