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Top 10 Q&A from the Free EUDAMED Webinar

Agnieszka Schreiber, BEng
Last week UDI Expert Agnieszka Schreiber hosted the Free Webinar on EUDAMED. Many interesting and useful questions were asked with more than 350 interested attendees. Read the top 10 questions of the Free Webinar now.

Will Distributors need to register in EUDAMED?

No, distributors are not subject to actor registration requirements according to Annex VI of the regulations. Member States may introduce national provisions on registration of distributors of devices being made available on their territory but it's not part of EUDAMED registration.

Do importers of MDD products need to register as an actor?

Not unless they transition to hold the same role for an MDR device.

As a manufacturer of devices, we are also a SPPP (combining our devices with some other CE marked devices). Would we have to register twice, with two separate SRN?

Yes, the roles of Manufacturer and System/Procedure Pack Producer will require separate registrations and separate SRN assignments. Please see also MDCG 2018-3.

When is the due date for product registration in EUDAMED?

Device & UDI registration is due within 18 months from the application date in case EUDAMED is available, or within 24 months from publication of a notice on verification of EUDAMED’s functionality in the Official Journal if EUDAMED is not available.

In relation to MDCG 2019-4, is it correct to say that deadline for entering data in EUDAMED as per Annex VI part A section 2 and Part B is May 2024? That is, if no vigilance report or PMS report is to be submitted prior to that? This is based on info that EUDAMED is fully functional for May 2022 according to the Commission.

This was an early interpretation based on legal advice that EUDAMED could only be released in one go for the full system. However, the Commission has more recently officially informed the community that EUDAMED will be launched module by module and it's expected each of them will be validated and functional at the time it's deployed. The legal foundation is however as stated earlier, and therefore the use of the first modules at their time of launching will be on a strongly recommended but virtual basis. In addition, the transition period of 24 months would apply from publication of the notice stated in Art. 123 and as of today it's not known if and when that publication will take place and what it will precisely entail. Our recommendation is to have the dataset ready as early as possible to avoid delays associated with e.g. data validation or data traffic. Future publications of EC, MDCG and DC Growth will need to be closely monitored.

Did the timelines for Vigilance (adverse events) change and if so, how?

The timelines in relations to vigilance obligations haven't changed as such but the ability to report a serious incident or FSCA in EUDAMED will depend on availability of the vigilance module. As of today, deployment of that module isn't specified.

Is it possible to delete entries in EUDAMED? Is it possible to change/correct previous entries in EUDAMED?

It’s not possible to remove/delete entries from EUDAMED. Only some attributes can be changed or corrected, for details please refer to the UDI Device Data Dictionary document (columns "Updateable" and "Updateable (version 'for Correction')").

Are MDD certified medical devices required to be registered in EUDAMED?

A 'Directive device' or so called 'Legacy device' will need to be registered in EUDAMED only for the purpose of vigilance reporting in EUDAMED, that is reporting of a serious incident or FSCA, please refer to MDCG 2019-4 and 2019-5. This requirement depends on the availability/functionality of the Vigilance module.

Will templates be available to use for populating data as part of UDI / Device registration?

The Commission isn't expected to make Device & UDI registration templates available since data can be submitted in different ways and for each of the entry points data is manipulated differently. The EC only provides guidance on data exchange.

When can one get or apply for Basic UDI-DI?

Manufacturers are required to assign Basic UDI-DI, it is not issued by or applied for in EUDAMED. The UDI-DI and Basic UDI-DI assignment is done by manufacturers in alignment with rules of the selected UDI issuing agency and then registered/published in the Device & UDI module of EUDAMED.

We are really excited to share our newly designed EUDAMED Training course since this topic is is a major part of the Medical Device Regulations (MDR) and the In Vitro Diagnostics. Click here for more information about our EUDAMED training course.

If you would like to learn more or need advice on if our training would be suitable for you and/ or your company, please feel free to contact us at info@qservegroup.com.

Regards,

Agnieszka Schreiber

 

 

 

 

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