EUDAMED Timelines (2023), Is it delayed again?

Who would have guessed that yet again we would have to write an article on another EUDAMED delay? In late October 2023, the European Commission published ‘draft’ EUDAMED timelines. We contacted the European Commission to make sure the draft was not a mistake, as they never publish drafts, and they said it was not a mistake. Mistake or not this delay is a little strange.

The development Clinical Investigation and Performance Study module (CI/PS) is being stopped and will restart in Q2 2024 and continue until Q3 2026, effectively adding two more years to the project. This delay also pushes back the all important “fully functional” EUDAMED designation. Why would they do this? It cannot be because of a lack of resources as the EUDAMED development team is almost 50 people, so why delay? And why a draft? Are they just testing the waters with this proposed massive delay?

The only reason we can think of is, the delay and the large amount of added development time, needed to extend the scope of the CI/PS module. We think, and this is pure conjecture, that we may see a policy change or an extension in the scope of the CI/PS module. We may still see Vigilance live in production after Q2 2024 just not mandatory, this has yet to be communicated.

For most companies, nothing changes, only the mandatory date of EUDAMED when becomes legally binding to report serious Vigilance issues in EUDAMED. The type of questions people are asking about how the delay affects them are as follows:

1. Because of the delay can we avoid uploading device data to EUDAMED? No, regardless of any delays you will still have to add your device data to EUDAMED.
2. If we delay adding my data to EUDAMED will it be a smaller and cheaper project? No, odds are the more people wait the busier the EUDAMED submission services will be, meaning fewer resources to help you and potentially making it more expensive.
3. Are there any benefits to delaying EUDAMED device data submissions? No, you have to submit your device data to EUDAMED either way, now or later. Getting it in now means it is finished, and done, and you can relax with this project. Delaying means you may put your teams under pressure as other regulatory jurisdictions may change their rules, the result could be you have multiple projects for data submissions running at the same time.
4. If we add our data now what else will we have to do? Only EUDAMED Maintenance, adding new products, updating changes, small easily manageable maintenance.
5. Is it being delayed to reduce the legacy devices being uploaded? We doubt it because they may still need to be uploaded because of Vigilance issues. For us submitting your legacy devices is important as it demonstrates a full history of your products.

Benefits of being in EUDAMED early

We have at least three Competent Authorities (Finland, Ireland, and France) making EUDAMED mandatory for registration and UDI data submissions. How many more will follow? Will the Competent Authorities make EUDAMED device submissions mandatory before the European Commission does?

The benefits include:

1. Your main EUDAMED project is finished, less pressure on your staff.
2. Other regulatory jurisdictions are looking to your CE mark and EUDAMED as a market entry point.
3. You can demonstrate that your product has met the world’s toughest regulatory market rules.
4. Some importers and distributors are looking at EUDAMED as a product catalogue.
5. Submitting directive and regulatory devices demonstrates the history of the device.

EUDAMED fully functional?

Based on this draft timeline EUDAMED will be “fully functional” in Q2 2027. If your company has not already submitted your device data to EUDAMED this is when you should get worried. Why? Because when EUDAMED is fully functional all serious incident vigilance reporting is mandatory in EUDAMED. To submit any vigilance record the corresponding device must exist in EUDAMED.

EUDAMED Submission Factors

What about other factors affecting EUDAMED submissions? Submissions are currently voluntary? Yes, according to the European Commission until EUDAMED is designated as fully functional submissions are voluntary. Is it better to wait, maybe for more delays? No, we would not recommend waiting because there is a lot of work in preparing your data to be validated, converted to XML and submitted to EUDAMED. There is definitive evidence that some importers, and distributors, are asking manufacturers where is their EUDAMED data because these actors have legal obligations to check EUDAMED for the existence of the data and its accuracy. Authorized representatives are asking manufacturers what is their EUDAMED strategy, without the strategy the certification process can stall. If your data is in EUDAMED these questions are no longer an issue.

EUDAMED Submission Experiences So Far

Our clients have uploaded thousands of devices to EUDAMED so far. Remember you can submit all your device data before EUDAMED is fully functional. With our EUDAMED UDI submission software options “EudaMed+” and “EudaMed SaaS” including our EUDAMED support and training. This support has consisted of explanations about the EUDAMED rules and help with UDI data preparations. To prepare for EUDAMED companies must collate their device data, this is a time-consuming exercise,?after which this data needs to be validated against all the EUDAMED rules a task easily completed using our submission software. It is during this validation process we have noticed that companies do not understand the EUDAMED. Companies lose a lot of time while trying to “fit” their data to the EUDAMED requirements due to a lack of understanding, we help with all of this.

Conclusions

EUDAMED is coming, nothing will stop it. You should not wait for EUDAMED to be fully functional especially if you want support from external resources. Preparing and submitting to EUDAMED is time-consuming, please do not risk being late by not starting ASAP.

Do not let the European Commission’s EUDAMED delay steer you off course, our strongest advice is, do not delay your EUDAMED device submissions. You do not know how other regulatory jurisdictions may change their rules at the same time as EUDAMED becomes fully functional which may affect your team’s ability to prepare data for EUDAMED.

You can find everything you need from training to UDI submission software and support on our site?Eudamed.com?Please do contact us about our products and support, we are here to sup

EirMed and our partners can help you. The EUDAMED project involves gathering the correct data, validating it against EUDAMED rules, and submitting it to EUDAMED. Next, you will require SoPs for EUDAMED management and maintenance. We can manage this entire project for you, from start to finish, without your team’s day jobs being disrupted for months.

EUDAMED is ready for your UDI Device data now, please do not delay.

??Special offer:?? New subscribers to our EUDAMED submission software will receive ??“FREE” access to our self-paced ‘EUDAMED Simplified’ training.