The European Commission(EC) has again delayed EUDAMED, this is their delay. Do not forget that we have at least one Competent Authority (Finland) and many importers making EUDAMED Services mandatory for registration and device submissions. Do not let the EC delay steer you off course, this delay affects clinical investigations and vigilance, the device module is in place albeit with a few bugs. My strongest advice is, do not delay your EUDAMED device submissions. You do not know what other regulatory issues may hit at the same time as EUDAMED becomes fully functional which may affect your team’s ability to prepare data for EUDAMED.
The European Commission (EC) published their EUDAMED timelines but what do they mean for me?
EUDAMED Development and Audit
Firstly the EUDAMED (version 1) development will end in Q4 2023. Following the end of the development, a regulation mandated audit of EUDAMED happens in Q1 2024 with the MDCG sign off in Q2 2024. The audit and approval by the MDCG are listed for 6 months, which is 3 months longer than expected, so all we can assume here is that is contingency time in case development is delayed and to allow for bug fixing.
The audit is a guaranteed pass for the EUDAMED software. The EC hires the auditors, the EC sets the terms of reference, provides the tests for the auditors to check, and finally, the EC signs the cheques for the auditors. While the legislation calls it an independent audit, the EC holding all the strings ensures that it is an audit with a guaranteed pass. Following the audit pass, we have the official journal publication, a huge milestone.
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EUDAMED Fully Functional?
Next, we have the “fully functional” EUDAMED, after the transition period which ends in Q4 2024. If your company has not already submitted your device data to EUDAMED this is when you should get worried. Why? Once EUDAMED is fully functional all vigilance reporting is mandatory in EUDAMED. To submit any vigilance record the corresponding device must be already in EUDAMED.
For those companies hoping to upload their data to EUDAMED in XML, automated or manually, you must remember there is a limited amount of potential resources that understand EUDAMED enough to help you. This required knowledge is where our company is very lucky as we have been involved directly with EUDAMED since 2011, no not a mistake I have been with EUDAMED since 2011, something no other company can claim. As more MedTech companies need support all private EUDAMED support and submission resources will be under pressure as deadlines approach. We and others like us will be working with existing clients meaning if you’re not already started on EUDAMED the help and the resources you need may not be available.
If you are late with your EUDAMED submissions, if you do not have your data in EUDAMED by the mandatory deadlines then legally you cannot sell your products within the European Union countries.
EUDAMED Submission Factors
What about other factors affecting EUDAMED submissions? Submissions are currently voluntary? Well yes, according to the European commission until EUDAMED is designated as fully functional submissions are voluntary. So you can wait? 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. Also, there is definitive evidence that some importers, distributors, and authorized representatives are already asking companies where is their EUDAMED data because these actors have legal obligations to check EUDAMED for the data and some are already taking this seriously. And we have Finland making EUDAMED submissions mandatory.
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 “EudaMed+” and “EudaMed SaaS” we include much needed support. 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 that we noticed that companies do not understand the EUDAMED requirements. Some companies lose a lot of time while trying to fit their data to the EUDAMED requirements as they understand them only to discover they must change a lot of their data entries after we have helped them otherwise EUDAMED will refuse to accept their uploads.
Some clients have completed our training course first to give them a clear understanding of EUDAMED. A small few of these companies had failed uploads which we didn’t expect, after all, they uploaded their perfect validated XML to EUDAMED only to fail. This was a surprise for all of us, once we checked the problems we found that EUDAMED itself was incorrectly implementing some of their own rules. We had to explain in detail to the EC and the EUDAMED support what the problems were and waited many weeks for a resolution. The lesson here is even if your XML upload fails the reason for the failure may not be your fault but a bug in EUDAMED. This, unfortunately, means that the failure messages you receive from EUDAMED may not always be correct, you need to double check the actual rules if you have doubts.
The EUDAMED train is running and nothing at this stage will stop it. If you want to sell your medical devices in Europe after EUDAMED is fully functional then you have to submit your UDI device data to EUDAMED. You can do it now stress free or leave it to the last minute and risk being late meaning you cannot sell your products within the European Union.
The EC has included plenty of time to allow for any future delays, and if this time is not needed the EC can launch a fully functional EUDAMED a lot sooner, so you must be ready. 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.
You can find everything you need from training to UDI submission software and support on our site hibccpakistan.org Please do contact us about our products and support, we are here to support you.
IVDR Submission dates:
- May 26, 2022 for Class A, self-certified – sell-off period until May 26, 2025
- May 26, 2025 for Class D – sell-off period until May26, 2026
- May 26, 2026 for Class C – sell-off period until May 26, 2027
- May 26, 2027 for Class B – sell-off period until May 26, 2028
- May 26, 2027 for Class A, sterile – sell-off period until May 26, 2028
MDR submission dates:
MDR Placing UDI-carriers on the labels of devices (MDR Article 123(3)(f), Article 27(4)):
- Implantable and Class III devices 26 May 2021
- Class IIa and Class IIb devices 26 May 2023
- Class I devices 26 May 2025
Direct marking of the reusable devices (MDR Article 123(3)(g), Article 27(4)):
- Implantable and Class III devices 26 May 2023
- Class IIa and Class IIb devices 26 May 2025
- Class I devices 26 May 2027