I am often amazed at the people who profess expertise in various fields. Lately the MDR Eudamed experts have been rolling out. Some have not been involved in the many European Commission working groups nor have they had any direct involvement with the teams designing and developing MDR Eudamed. Yet they are “experts”. This is dangerous for the MedTech industry because many companies will listen to these “experts”.
This article is for anyone who has listened to the Eudamed myths and misinformation.
Who am I? Why should anyone listen to me? Firstly, Eudamed is a monster, a huge system, a system too big for anybody to know everything about it. However, I am exceptionally knowledgeable because of my direct involvement in the European Commission Eudamed project; in fact, I led the Eudamed IT development teams until April 2019 when I finished working with the EC.
I would now like to debunk the myths and correct a lot of this misinformation.
Myths and Misinformation
Myth: The EC will reverse its decision not to use GMDN codes.
- CND is going to be the Eudamed nomenclature, this is decided and this fact will not change. This is a fact and the relevant decision has been officially published. The mapping exercise between GMDN and CND either has started or will start shortly but this CND decision is final.
Myth: As so many companies are not ready for Eudamed, the EC will have to delay.
- The EC will not delay its timetable to suit industry. We have to remember the EC remit is to produce and implement directives and regulations. The EC’s role is not to facilitate companies who have not planned nor started the required projects to implement these directives and regulations. The EC and the member states view is that the companies have had plenty of warning, the MDR existence is no surprise and Eudamed is coming in March 2020. Companies failure to plan, prepare, and implement their IT projects is not an issue for the EC, these are issues for the industry and the relevant companies. Recently the Commissioner for health and food safety, Vytenis Andriukaitis said, “any change of rules at this late stage would be unfair to serious operators that have carried efforts to ensure their timely compliance.”
This does not sound like any postponement will be forth coming.
Myth: The EC has not published clear enough information for us to start our Eudamed projects.
- This is not true. Everything needed for companies to start their Eudamed IT projects is in the public domain. There are some more informational artefacts to come but these do not preclude companies from starting their projects, for example the business rules, and CND codes. The missing artefacts will come but are not a big enough excuse to avoid starting the required projects. There is certainly enough information available for your teams to start preparing and coding the required projects.
Note: If an IT team, manager, programmer or analyst, feel they do not have enough information to proceed with, then companies should put them on a training course. Teams can waste weeks of very expensive time deciphering the EC requirements, whereas a one-day training course in Eudamed preparation can save weeks of analysis and mistakes coming from incorrect decision-making. This training is not only time saving but also a valuable investment.
Myth: The EC’s published XML samples and XSDs are not validating, how can we proceed?
- This is partially true. Companies can wait for the EC to update the samples and XSDs but this could mean wasting valuable weeks, as the EC takes time to publish anything.
Eudamed.eu have taken the time to fix these issues. We have updated the XSD in question and the samples now validate correctly. If anyone wants the download link then please contact us, firstname.lastname@example.org and we will send you a link to the validated samples and the fixed XSD, free of any charge.
Myth: We do not need an IT project now as all of our devices are MDD certified and will not require re-certification for years, so we have time.
- Not entirely true. If there is a Vigilance issue then you have to have your device data in Eudamed. Eudamed will reject MIR submissions if the device data does not pre-exist in the system. From May 2020, all MIR submissions will have to be via MDR Eudamed, for both MDR and MDD devices. We recommend that you submit all legacy devices (MDD) as soon as possible to avoid issues of device data not being present in Eudamed in the unlikely event of a vigilance issue. Better safe than sorry, delays in vigilance reporting can be costly.
Myth: Eudamed will not be fully functional by March 2020 and the legislation says it must be fully functional before go-live so it will have to be delayed.
- Firstly, what exactly does fully functional mean? It is ambiguous. Fully functional in terms of what? MDR? The functional specifications? Every single module?
In reality, the EC decides what is fully functional. Certainly, Eudamed will be working and delivered on March 26th 2020, but not every single function will be there on day one. However, Eudamed will work, it will be functional and companies will be required to register both themselves and their devices. There should be no doubt in anyone’s mind that Eudamed will be there on March 26th 2020.
Myth: The EC is going to provide us with all the support we need, our IT teams can just contact them.
- The EC will provide manuals, FAQ’s, various IT targeted publications (e.g. Data Dictionary, XSD, etc.), and a functional mailbox where people can submit questions. They will not provide a call centre. Manufacturers with technical issues relating to failed uploads, XML not validating against the XSD, or data dictionary questions, will not have EC support people at the end of a phone waiting to assist them. This will simply not happen; the costs of such call centre would be too big a burden. Companies will have to rely on their own IT experts and/or external support companies to answer such questions. Providing IT support is not the role of the EC.
Myth: Eudamed will not be ready in March 2020, we heard there are lots of delays.
- Eudamed will be delivered on March 26th 2020, the EC will not accept nor allow a delay on this date. In its first release, Eudamed will not have every single piece of functionality or module available but be forewarned, it will be live on March 26th 2020.
Myth: We can apply to our Competent Authority in advance for a SRN.
- This is completely wrong. The SRN is an Eudamed generated alphanumeric string that will be available to each registering company after they have registered in Eudamed and have been successfully validated by their competent authority (CA). This CA validation and SRN creation can only happen on or after March 26th 2020, when Eudamed goes live.
Myth: The SRN will be the same format as our VAT number.
- This is another incorrect piece of information. In the XSDs published by the EC in June 2019, the format of the SRN is included. This is the format of the SRN:
Length 15 characters Format: ISO Country Code-Actor Type-9 digits Actor type example: Manufacturer: MF, Importer: IM Full code: IE-MF-000000001
Thank you for your attention, I hope this has helped clear up some of the Eudamed myths.
About the author
Richard Houlihan is the CEO of Eudamed.eu, a company in a unique position to help MedTech companies with their Eudamed preparation, training, and support. This unique position is because of Richard’s direct involvement with MDR Eudamed within European Commission. The company provides several services from Training, Support, and Consultancy, to Keynote speaking on Eudamed. In addition to providing Software as a Service, and Machine-2-Machine access point preparation, management, and support.
© 2019 Eudamed.eu