As the date of application of the EU MDR remains May 26, 2020, the European Commission officially stated that EUDAMED’s launch will be delayed to the date of application for in-vitro medical devices in May 2022.

Therefore there is no need to care about UDI for now anymore, isn´t it?

In the following article on bvmed.de, our co-founder Patrick Pfau explains why UDI will still be necessary considering the requirements of EU MDR and how to overcome upcoming challenges related to UDI.

Find out here why to prepare now. (german version)

You can read the english version below.

 


English Version: 

As the date of application of the EU MDR remains May 26, 2020, the European Commission officially stated that EUDAMED’s launch will be delayed to the date of application for in-vitro medical devices in May 2022.

Therefore there is no need to care about UDI for now anymore, isn´t it?

In the following article, I will explain why UDI will still be necessary considering the requirements of EU MDR and how to overcome upcoming challenges related to UDI.

 

What exactly is EUDAMED and why will it be delayed?

EUDAMED is the new EC database on medical devices, which should improve transparency and coordination of information regarding medical devices available on the EU market.

Therefore it contains the following modules: Actors, UDI & devices, notified bodies & certificates, vigilance, clinical investigations & performance studies and market surveillance.

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 is postponed for two years and medical device manufacturers have more time to submit all the above mentioned required data and documents to the EUDAMED database.

In order to be ready for EUDAMED, the MedTech industry was especially worried about preparing all the required UDI data in time – as there is now more time to prepare, the UDI issue can be ignored for now, right? The answer is “no”, because 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 May 26, 2020. Having your UDI data on hand will be unavoidable and here are the reasons why.

 

UDI’s role for the whole EU MDR

The unique device identification (UDI) is a unique numeric or alphanumeric code pertaining to a medical device and has two parts: a device identifier and a production identifier. The specificity of the UDI makes traceability of devices more efficient, allows easier recall of devices, combats counterfeiting and improves patient safety.

Additionally to UDI, the manufacturer shall also assign a Basic UDI-DI to its devices, or device groups to be more precise. The Basic UDI-DI is the main key in the database and mandatory for relevant documentation (e.g. certificates, declaration of conformity, technical documentation and summary of safety and clinical performance). Therefore, based on current information all upcoming certification processes under EU 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 certificated under MDD with substantial changes need to be certificated under MDR, which requires the respective Basic UDI-DI’s as identifier.

To create Basic UDI-DI`s, you need to classify and re-organize your product portfolio in order to identify the right grouping of your products under one Basic UDI-DI. Devices with the same risk-class and intended use will group under the same Basic UDI which will be the common identifier for this product family. This means you already need to have the product specific attributes in place to be able to classify and re-organize your product portfolio.

The MDR also 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. But in order to be prepared for this scenario, you also need to have your UDI data already on hand. Also keep in mind that the labeling requirements and timeline for applying UDI-compliant labels won’t change as well.

As you can see, the delay mainly affects the data exchange with EUDAMED, not the future necessity of UDI as soon as EU MDR becomes applicable. Therefore, despite the delay of EUDAMED, the topic UDI still has a high relevance for EU MDR.

So how should you prepare to be ready for EU MDR with respect to UDI? As there are a lot of points to consider, I would like to give you a brief overview on how an comprehensive UDI setup for EU MDR should look like.

 

How to get your UDI data ready

Regarding to EU MDR, controlled governance processes are currently top priority in order to have your UDI data in place whenever needed. Therefore you need at least a data governance system where you can classify and re-organize your product portfolio in order to create Basic UDI-DI’s as explained before. This might be possible in your existing ERP system, but in order to be prepared for EUDAMED and other regulatory databases worldwide which will arise soon (e.g. China, Saudi Arabia, South Korea), a software specialized on UDI processes will support you to achieve worldwide UDI compliance.

Entering your device attributes directly into the respective database might be possible for small product portfolios, but ends latest when your QM department demands controlled maintenance processes for your core data elements.

To have all UDI related processes covered in your software, the vendor of your choice should be assessed carefully for the following requirements (especially regarding EUDAMED):

  • Data governance process – you should be able to maintain your UDI relevant data in a controlled way with clear workflows
  • Continuous delivery of the most recent data attributes demanded by EUDAMED to comply with current EUDAMED version
  • Handling of Basic UDI processes in conjunction with UDI processes
  • Handling of directive devices under MDD with EUDAMED-DI and EUDAMED-ID
  • Configurable workflows covering the various stakeholders in your organization
  • Validation of all data inputs against most recent Business rules of EUDAMED
  • Integration options with your ERP and Regulatory Information Management Systems
  • Access point and submission interface for handling data exchange with EUDAMED
  • Support of validation processes by your vendor
  • Audit Trail and FDA CFR 21 Part 11 compliance for electronic records

Besides, keep in mind that following UDI regulations will remain an ongoing task – you may reflect this in your organizational setup like large Medtech companies do, but at least you should consider this in your project structure, as a UDI-program is evolving out of your MDR UDI-project. It saves valuable time if your team of UDI stakeholders is already set up and can react on upcoming requirements timely. Same conditions apply to software vendors: they should give you guidance on their future direction, how compliance in other markets is ensured and how the vendor assists in timely delivery of changes demanded by the authorities.

Furthermore, options to support UDI Track & Trace should also be considered as this will become highly relevant in the future, too.

 

UDI as a global challenge

As above mentioned, your UDI setup should be able to cover the requirements of various regulatory authorities in case you’re active in more than one market. So keep this in mind and look for an expandable solution. No matter if EUDAMED is your first UDI-project or if it will be another country, your UDI-project will extend to an ongoing UDI-program as China, South Korea and Saudi Arabia are to follow in 2020 and other regulatory authorities are on track, too.

 

About the author

Patrick Pfau is co-founder of p36.labs, an SAP Software partner delivering Life Sciences solutions with the UDI Platform as its core product focused on covering UDI requirements worldwide. Patrick has a high expertise on business and technical UDI requirements of regulatory authorities worldwide and already gained various practical experiences within implementation and pilot projects for different regulatory authorities.

Find out more about Patrick and p36.labs: https://www.p36labs.com/