Published on December 6, 2019

Dear reader,

exciting times are ahead.
Are you still confused about the EUDAMED delay and how it affects the MDR requirements related to EUDAMED implementation?
EU MDR may be currently the biggest issue of the MedTech industry, but did you know that UDI will become a global challenge beyond EU MDR?

That’s why we prepared this regulatory update giving you guidance on how to deal with UDI for EU MDR for now as well as an overview of upcoming key actions of regulatory authorities in other markets.

Best regards
Patrick Pfau

EU MDR overview
Global regulatory overview

 

Beyond EU MDR – UDI as a global challenge

Becoming effective in May 2020, EU Medical Device Regulation (MDR) is close and despite the delay of EUDAMED, UDI will be still important. Additionally, more countries around the globe (e.g. China, South Korea and Saudi Arabia) are to follow which also require an UDI setup.

So that you won`t lose track of the upcoming global challenges, we would like to give you an overview on what to keep in mind for 2020.

 

EU MDR overview

EUDAMED delay – why UDI is still important for EU MDR

According to the EC, it will only be possible to make EUDAMED operational once the entire system and its different modules have achieved full functionality, which is the reason why its launch will be delayed to the date of application for in-vitro medical devices in May 2022.

Did you know that UDI will not only be mandatory for the data submission process, but also for other processes within the EU MDR which date of application remains 26th May 2020?

Based on current information all upcoming certification processes under MDR will require the Basic UDI-DI (e. g. as identifier on technical documentation, declaration of conformity). Although there will be a transition period for re-certification of legacy devices until 2024, all new devices and devices certified under MDD with substantial changes need to be certificated under MDR, which requires the respective Basic UDI-DI’s as identifier. Also keep in mind that the labeling requirements and timeline for applying UDI-compliant labels won’t change as well.
In addition, the MDR states that in case of a recall or Field Safety Corrective Action (FSCA) all UDI data need to be submitted upfront, although it is not clear yet how this process will be handled during EUDAMED delay.

If you want to find out more about UDI’s role for the whole EU MDR and how to overcome the related challenges, read the latest article of our co-founder Patrick Pfau on our website.

 

Timeline for EU MDR

So that you keep track in the future, we have prepared a timeline with the most important stitch data for you:

 

Global regulatory overview

UDI is a global challenge, so keeping an eye on other markets is imperative. Here are some important informations about our selected markets, which will also be performing key actions in 2020.

From July 2019 to June 2020, China FDA is running a UDI pilot to verify the functionality of its UDI database. The go-live of the Chinese UDI database is planned with the date of application for implantable devices on 1st October 2020.
The Korean MFDS is already applicable for class IV devices and class III devices are to follow – the date of application will be on 1st July 2020, including labeling and UDI master data.
Saudi Arabia’s SFDA released guidance on UDI in April 2019 and the go-live of Saudi-D database is planned within the next months.
Class D will become applicable 6 months after Saudi-D is available, Class B and C one year after availability and Class A two years after availability of Saudi-D.
On 24th September 2020, FDA regulations will become applicable for class I devices.

 

Global Timeline

We have also prepared a global timeline covering a bigger picture starting in 2019 until 2022 for not losing track on global UDI requirements:

 

UDI Platform – one solution for all UDI databases

p36.labs offers the strategic answer for your UDI challenge with the UDI Platform.

It allows you as a medical device manufacturer/labeler to meet the requirements of regulatory agencies around the world – fast, flexible and easy to use.

Starting with FDA and EUDAMED, we build Content Packages for each regulatory authority and provide them as solution extensions.
They are the answer to the specific requirements of regulatory authorities, containing the specific data model, data validation rules and the complete handling of exchanging data with the authorities.

New Content Packages are to follow as soon as other regulatory authorities announce further details about their UDI regulations. They can be added easily to the UDI Platform at any time for worldwide UDI compliance.

 Visit us for more information or view the video below!

 

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