February 22, 2024
Dear readers,
it seems that the authorities have not slowed down at the turn of the year and industry must be prepared to react flexibly on coming updates, changes and totally new requirements not forgetting about deadlines already known.
Below you will find most appealing information we received since last issue of newsletter in November. UDI timeline visualization accompanies the cited news.
We would like to point out that the information provided has been selected very carefully by us. Nevertheless, we cannot guarantee or assume liability for the timeliness, accuracy, completeness, or omission of the published information. Further information can be found in our disclaimer.
Best regards,
Pascal Appel
UDI Content Package Manager
Reporting news about timelines in EU is like riding a rollercoaster!
Recent hot topics are:
And as they are all dependent on each other, were combined into one proposal of amendment of MDR and IVDR together. From UDI/EUDAMED perspective it looks like those who were not waiting for the last call will benefit, reducing manufacturers efforts and burden on local competent authorities and finally delivering information to general public. Refreshed timeline proposed as of now is to split release of EUDAMED into 3 sets:
Enabling of individual EUDAMED modules once they have been audited and declared functional could mean: It is suggested mandatory usage of 1st and 2nd set of modules could start in January 2026.
We recommend everyone to watch Procedure 2024/0021/COD really close in coming weeks!
Amendment still needs to be clarified, which parts of EUDAMED could be launched earlier and how it will be coordinated with other MDR/IVDR applicability timelines.
The turn of the year has brought us, unexpectedly, totally refreshed appeal of UDI Portal, now known as ‘Medical Device Safe Bookstore’.
From UDI and M2M data exchange perspective, main change was API host address replacement as the database was migrated into new space. Obviously, all functionalities and datasets were upheld.
We observe huge step forward from MFDS side as the team responsible for ‘emedi’ is way more open in communication and is constantly seeking upgrades in provided databases, making life of manufacturers and 3rd party providers like p36 easier. For example, in February they announced a campaign of gathering ideas for improvements for all services, we encourage you to share it with local affiliates and us to actively support the IMDIS improvements.
Moreover, there are whole new documents, namely the whole rebuilt User Guide that puts much more light on the requirements that many companies have struggled with!
For China we would like to remind you that the next deadline is approaching!
June 1, 2024 marks a date when so called ‘3rd Batch’ of medical device fall under mandatory UDI registration. This group consists mostly of Class II products.
There is no official information provided yet, but we expect NMPA announcing soon the deadlines for Class I devices, predicted by us for 2026.
Saudi-DI is operational again! Last time we informed about the technical break that had happened but since then the system is stable and operational.
One thing worth noticing is that SFDA has refreshed the Mass Upload templates for bulk operations once again. If you are preparing for submissions this year please reach out to local contact and fill in data in newest template.
September 1st is deadline for Mandatory Class A UDI registration, we recommend starting early, as knowing the low risk devices are another huge batch of UDIs to be registered, and we all have in mind Saudi-DI had to make a technical break around last deadline of UDI registration last year.
TGA still has not confirmed dates of releasing the AusUDID productive environment, but we want to ensure you testing is happening now at full speed now, also with our p36 involvement, and tentative implementation timeline seems feasible to match!
That means voluntary compliance with AusUDID UDI data provision to be enabled ~Q2 2024!
Mandatory compliance for high risk device classes could start then as early as Q1 2025!
Regulatory drafting is still ongoing process (originally scheduled till end of 2023) and full AusUDID release package is not yet closed but we can expect TGA will close those topics till the end of Q1 2024.
In the meantime to prepare better for AusUDID implementation there are AusUDID Data Dictionary and Bulk UDI upload template made available to the public.
ANVISA consequently failed to deliver any new resolutions last years, even though UDI Database creation was envisaged for 2020-2023 we cannot share any information on the progress from the authority side.
Currently we know what kind of data would be needed as data model was already proposed but there is no place to store the data, and there are no signs of progress from ANVISA to establish the database soon.
We will keep monitoring the progress in Brazil and inform you as soon as we find interesting news on UDI implementation in this country!
Preliminary deadlines we were sharing on our UDI timeline were based on assumption the database would be created in timely manner.
On 9 January 2024, the MHRA released a ‘Roadmap towards the future regulatory framework for medical devices’.
What drags our attention is that MHRA plans to hold a series of discussions with stakeholders this year and seems committed towards drafting regulations in 2024 and releasing them as early as next year.
Unique device identification requirements – is marked to be discussed in the second part of 2024.
We will inform you about the progress as soon as more concrete news are available!
Swissmedic has confirmed the finalization of Actors module implementation and confirms further progress of UDI module development.
Unfortunately they see some delays are inevitable due to technical complexity.
Here are the new deadlines:
That means first voluntary registrations of UDIs in MVP environment can start as early as beginning of 2025!
We understand that if EUDAMED would be deployed earlier than planned, SwissDAMED should follow with its full operational readiness shortly after.
We will inform you about possible data transmission options as soon as technical specification is made available.
UDI landscape has brought us significant updates last months:
South Korea is seeking opportunities to improve user experiences and usability of medical device online services now merged under ‘emedi’ platform.
Prepare yourself, China and Saudi Arabia are approaching with UDI deadlines this year.
Australia is working hard on bringing functional databases for the industry this quarter!
UK seriously started to create the future of medical devices on their market.
Brazil is not progressing with UDI implementation at all.
Overall, some markets have slowed down where the others show increased activity. Remember about upcoming deadlines!
As always global regulators prepared new UDI requirements and shifted deadlines. This is not a one time project, but more a long term and ever changing global process right now. We are sure that UDI will bring challenges throughout coming and next years. That is why we at p36 will continue to monitor global market requirements for UDI as before and continue to work on the best possible solution for our customers so they can focus on their core business.
We hope this newsletter has given you a helpful overview on the current UDI requirements all over the world.
Please keep in mind that timelines may change.
As usual, we will inform you on our social media accounts at short notice in case of any updates.
Do you have any questions or suggestions regarding our newsletter?
We appreciate to hear from you.
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All information relates to the current state of knowledge of p36 at the time of publication. We endeavor to select all information provided with care and to update it as necessary, but all information/future-oriented statements are subject to various risks and uncertainties that may cause actual results to differ materially from expectations. Readers are therefore cautioned not to place undue reliance on such information/future-oriented statements. The information may not be incorporated into any contract.
p36 does not warrant or assume liability for the timeliness, accuracy, completeness or omissions of the information published. The information does not constitute a commitment, promise or legal obligation. All information does not constitute advice in the legal sense. p36 assumes no responsibility for the legal force and legal admissibility of the content and information. The information is provided without warranty of any kind, either express or implied.
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