June 20, 2023

Regulatory Update 06/2023

Dear readers,

the year 2023 has just reached its midpoint but have already had served us variety of changes to the UDI landscape. We would like to give you an overview about what has happened since the last issue of newsletter in November last year.
Additionally, you will find a brief outlook on UDI requirements in years 2023 to 2025, of which we are currently aware. Besides this, you will find a short summary of the most important aspects in the section “UDI in a Nutshell”.

We hope this newsletter helps you to prepare yourself for the next steps towards your global UDI compliance.

As usual, 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.

Stay healthy and confident!

Best regards,

Pascal Appel
UDI Content Package Manager

Review of UDI in first half of 2023

In Europe, the MDR transitional period was extended and the EUDAMED database is starting to become mandatory. The FDA in the U.S. set a deadline for phasing out the use of certain codes in favor of UDI. South Korea, China, Saudi Arabia, Taiwan, Singapore, Brazil, Switzerland, and the United Kingdom have also made progress in their UDI implementation. The UDI support team in Australia has announced the decommissioning of the UDI Sandpit and the launch of the AusUDID Pre-production environment.

Overall, UDI compliance requirements and timelines vary by country, making it essential for medical device companies to establish a global UDI strategy.

The following section therefore provides a brief overview of what we consider have been the most recent changes worldwide for you as a medical device manufacturer.

Europe I EC (EUDAMED)

It is official! MDR transitional period has been prolonged and sell-off clause is liquidated. Regulation 2023/607 provides much needed time to accomplish certification under MDR for legacy devices. Proposed last year new timelines are upheld:

  • December 2027 for Class III and Class IIb implantable devices.

  • December 2028 for Class IIb, Class IIa, and Class I devices.

Important fact

To fully benefit from new transitional period your company should establish MDR (including UDI!) compliant QMS and submit application for conformity assessment to notified body by May 26, 2024.

Moreover this new transitional period does not apply to MDR and IVDR requirements regarding UDI labelling and implementation for your regulations compliant devices!

UDI labelling

May 26, 2023 is an important date, as four different categories of medical devices should be made UDI compliant in EU by then:

  • MDR Class IIb & IIa

  • Direct marking, Reusable MDR Class III

  • IVDR Class D

EUDAMED database

Voluntary registration of medical devices is now open! Obligatory use timeline remains unchanged from proposed a year ago database readiness dependent timeline;

  • Q2 2024 Fully operational EUDAMED database launch

  • 2025 Partially mandatory data registration

    (*6 months after fully operational)

  • Q2 2026 Mandatory for all Classes of medical devices

    (*2 years after fully operational)

Remember that some legacy devices will also have to be registered even when not falling under Basic UDI and UDI requirements upon EUDAMED launch.

USA I FDA (GUDID)

In October 2022 FDA issued a reminder for all companies still using National Health Related Item Code (NHRIC) or National Drug Code (NDC) numbers on device labels and device packages that from September 24, 2023 it will be prohibited to do so. Those codes can still be in use for e.g. reimbursement traceability purpose. FDA withdraws these two coding systems (originally assigned by them on demand) in favour of UDI that should already be standard for identification of medical devices.

Moreover the same deadline applies to all devices using Universal Product Code (UPC) as primary identifier and were registered in GUDID under UDI alternatives UDI-A160001 and UDI-A16002. If your company still uses any of those exemptions- now it’s time to update UDI compliance policy for your labelling as after the deadline all newly manufactured devices can’t have NHRIC and/or NDC nor UPC codes used instead of UDI.

Since December 8, 2022 Class I and unclassified devices, other than implantable, life-supporting, or life-sustaining devices, regardless of whether they are consumer health products or not fallen under obligatory GUDID submission requirements. This was the last group of devices that should be submitted to the database, we are sure it was a piece of cake for UDI platform users.

South Korea I MFDS (IMDIS)

From July 2022 use of UDI is mandatory for all four medical devices classes. Surprisingly it’s not the last deadline that medical device industry have to meet.

From July 2023 track and trace for medical devices subject to tracking and control is going to be mandatory for Class I devices. If your device is classified under Class I and listed on the list of 52 covered devices that are implanted into a human body for over one year or life-sustaining items that can be used in places other than medical facilities- remember to start monthly reporting after closing sales in July.

China I NMPA (CUDID)

In February, NMPA officially announced deadline for UDI compliance for next part of medical devices. So called ‘3rd batch’ covers mainly Class II devices such as some single-use products with large clinical demand, selected products in centralized procurement, and medical cosmetology-related products.

From June 2024 it is mandatory to assign UDI to smallest sales unit. Registration of UDI to CUDID is based on ongoing lifecycle action submission date, so it is important to not forget including UDI compliance to upcoming variations or registrations of your medical devices in China that can come in the period around given date.

Saudi Arabia I SFDA (Saudi-DI)

Saudi Arabian regulatory authority SFDA had no news about UDI compliance so far for medical devices manufacturers since our last newsletter. This year will be a big step forward as we are close to mandatory UDI submission deadline, even though database is operational since December 2020 and allows voluntary submission we expect most of submissions done this and next quarter.

Just to remind you – all medical devices Class D, C and B should be UDI compliant and submitted to Saudi-DI from 09.2023.

Australia I TGA (AusUDID)

Recently, the UDI Support team is notifying UDI stakeholders about the decommissioning of the UDI Sandpit environment. Starting from June 1, 2023, the Sandpit will no longer be accessible, and all previously submitted data will be permanently deleted. They will soon invite Sandpit users who registered as data providers to access the new AusUDID Pre-Production environment. Additionally, users who registered as data users will receive a link to the unauthenticated public facing AusUDID Pre-Production environment.

We all are still waiting for TGA to set up new timeframes for Australia, indications are that full UDI compliance will not be achieved by 2027 as planned before.

Taiwan I TFDA (UDID)

Last time we were reminding that TFDA announced that starting from June 2022, license holders of Class III medical devices are required to upload UDI and corresponding product information to the UDI database (UDID).

This year medical device manufacturers are required to place UDI on the Class II medical devices, starting from June 2023. Those devices shall also meet relevant requirements of Medical Devices Act and be submitted to UDID.

Currently there are no foreseen plans for Class I devices UDI submission requirements.

Singapore I HSA (SMDR)

Last time we informed that since November 2022 Class D high risk implantable devices are required to be registered with HSA on the SMDR via MEDICS prior to their placement on the Singapore market. Right now the deadline for final supply of those devices imported before November 2022 passed on May 1, 2023.

Rest of Class D medical devices will be required to register in the database by manufacturers or importers from November 2024.

We would also remind you that Class A medical devices are required to be listed on the ‘Class A medical device database’ but both registration and UDI implementation still remains non-mandatory until further notice.

Brazil I ANVISA

Brazil so far only made obligatory UDI compliance for selected implantable Class IV devices from regulation implementation date on January 1, 2022.

Next deadline for UDI compliance for the rest of Class IV devices is on July 10, 2024.

Unfortunately there is still no information about development and precise requirements of UDI database. We only know it is in the scope of strategic plan for years 2021-2023 for Brazil healthcare system.

Switzerland I Swissmedic (SwissDAMED)

On March 29,2023 The Federal Council committed to grant an extended period for the certification of medical devices, in line with the extension of the equivalent European regulation. Plan is to amend Medical Devices Ordinance (MedDO) and the Ordinance on In Vitro Diagnostic Medical Devices (IvDO) in Switzerland in autumn 2023 to reflect changes in MDR and IVDR proposed by European Commission.

UDI compliance dates stay unchanged and are in line with proposed by European Commission.

How does it impact SwissDAMED implementation?
Initially planned release in 2023 could be probable but as Swissmedic always underlined that registration will only become compulsory with the relevant amendment to the MedDO / IvDO we should wait till autumn to see how the situation develops.

United Kingdom I MHRA (DORS)

Currently UK authority MHRA accepts CE marked devices until June 30, 2023. Good news from is that they intend to issue amendment (before deadline) to UK MDR to prolong deadlines to ease fulfilment of post Brexit compliance requirements for medical devices in United Kingdom and adjust to European Commissions latest amendments.

New proposed timelines below:

  • EU MDD and AIMDD compliant medical devices with a valid declaration and CE marking can be placed there up until the sooner of expiry of certificate or June 30, 2028.

  • EU IVDD compliant medical devices with a valid declaration and CE marking can be placed there up until the sooner of expiry of certificate or June 30, 2030.

  • EU MDR and IVDR compliant medical devices can be placed there up until June 30, 2030.

Important detail

Generally speaking only Class I medical devices and other types that did not require a notified body Involvement in conformity assessment for ‘EU Directives’ and now would require notified body involvement to acquire ‘EU Regulations’ compliance could still be placed on UK market.

MHRA also declares to issue new ‘future medical devices regulation’ later this year to put it into force mid 2024 and require full compliance from 2025. We will update you in the next issue of newsletter how they could stick to a plan.

UDI compliance calendar

UDI compliance dates 2023

UDI in a nutshell

The UDI landscape in 2023 has already seen a number of changes.

  • In Europe, the MDR transitional period was extended and the EUDAMED database is starting to become mandatory.

  • The FDA in the U.S. set a deadline for phasing out the use of certain codes in favor of UDI.

  • South Korea, China, Saudi Arabia, Taiwan, Singapore, Brazil, Switzerland, and the United Kingdom have also made progress in their UDI implementation.

  • The UDI support team in Australia has announced the decommissioning of the UDI Sandpit and the launch of the AusUDID Pre-production environment.

Overall, UDI compliance requirements and timelines vary by country, making it essential for medical device companies to establish a global UDI strategy.

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 that this update has given you a helpful overview on the current UDI requirements around the world. If you want to be informed about the current regulatory requirements before anyone else, you should subscribe to our Regulatory Newsletter.

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.

Pascal Appel

Pascal Appel

About the author

Pascal Appel is UDI Content Package Manager at p36.
With a strong background in Unique Device Identification (UDI), Pascal is responsible for developing and managing Content Packages within the UDI Platform. His expertise in UDI regulations and compliance ensures that MedTech companies have access to accurate and comprehensive information for their UDI needs.
Pascal’s role is to provide valuable insight and guidance to help MedTech companies successfully navigate complex UDI requirements.

Disclaimer

p36 assumes no liability or responsibility for damages or consequential damages of any kind arising from the use of the information provided. All information, statements and data provided are non-binding and may be changed or deleted in whole or in part by p36 at any time without prior notice.
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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