Dear reader,

Keeping you up to date with regulatory changes around the world to enable you to prepare your UDI data as soon as possible to comply with regulations is very important to us.

With this newsletter, we would like to inform you in a condensed mode about the latest changes on UDI-relevant topics and give you an overview of upcoming compliance dates.

Furthermore, we would like to announce our next webinar which will take place on November 23, 2021.

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,
Your p36-team

Compliance dates October 2021

Content

UDI in Europe

UDI worldwide

Conclusion and outlook

Webinar: How to build a company-wide and global stragy for UDI

UDI in Europe

Since October, the 2nd module for UDI/device registration and the 3rd module for certificates and notified bodies (MVP) are available in the EUDAMED database. The usage currently is on voluntary basis.

IVDR: proposed deadline

With regard to the IVDR, the European Commission has proposed to extend the deadline for the in-vitro medical regulation by 3 to 5 years — including for COVID-19 tests — to avoid supply shortages.

The In Vitro Diagnostic Medical Devices Regulation was originally to apply from May 26, 2022.

The extension to the application of the new certifying rules will now vary depending on the type of IVD product. Higher risk devices such as HIV or hepatitis tests (Class D) and certain influenza tests (Class C), will now have a transition period until May 2025 and 2026, respectively, while lower risk ones such as Class B and A sterile devices, have a transition period until May 2027.

UDI worldwide

China I NMPA (CUDID)

In September the NMPA announced the official deadline for the registration of medical devices in the Chinese UDI database CUDID. With this decision the remaining medical devices from Class III now have to be registered by June 1, 2022.

It is advisable to timely begin preparing data for submission for the Class III deadline.

We released the China NMPA UDI content package for the UDI Platform by end of September to support data governance and submission to the chinese CUDID database.

The content package for China offers the following features:

  • UDI data governance and submission to the CUDID database,
  • Reuse of existing data (Common Device Data) with the Common Data Model (CDM),
  • Includes implementation of the data model, validation rules and best-practice workflow based on the official NMPA guidelines,
  • Includes Machine-2-Machine submission interface to NMPA CUDID database.

South Korea I MFDS (IMDIS)

For South Korea, Class II devices are applicable since July 1, 2021.

Using our content package for South Korea, relevant UDI data can be maintained in our UDI Platform and transferred to the MFDS database, IMDIS, via M-2-M submission interface.

The next deadline for Class I devices expires on July 1, 2022.

Singapore I HSA (SMDR)

Singapore published its final HSA Guidance on UDI for the placement of medical devices.

The first phase will start by November 1, 2022 with high risk implantable medical devices, such as coronary stents, orthopaedic joint replacement implants and intraocular lenses.

The regulatory authority of Singapore, HSA, will review the learnings from phase 1 and use these experiences to readjust the database and requirements for the following implementation phases for the registration with SMDR.

UK I MHRA

At the moment, the MHRA is consulting the public (such as patients, medical device researchers, developers, manufacturers and suppliers, clinicians, other healthcare professionals and the wider public) to give their feedback to obtain their views on the introduction of a UDI system and the future regulation of medical devices in the UK.

This consultation closes on November 25, 11:45 pm (GMT+1).

Conclusion and outlook

In order to prepare for upcoming regulatory authorities and their requirements on UDI, we want to provide you with a short overview of those authorities that are supposed to come up in 2022.

Saudi Arabia I SFDA (SAUDI-DI)

As we already informed about in our last newsletter, the next content package we will introduce will be the one for Saudi Arabia, in order to provide our customers with the opportunity to prepare their UDI data for the saudi arabian database SAUDI-DI.

The following compliance dates apply to UDI data registration in Saudi Arabia:

  • Class D, C & B medical devices must be registered by September 1, 2022,
  • Class A medical devices must be deposited in SAUDI-DI by September 1, 2023.

U.S. I FDA (GUDID) 

Class III and II medical devices must already be registered in the United States. Next year, also the deadline for Class I devices starts. All Class I medical devices, as well as unclassified devices and certain devices that require direct labeling, must be registered with the FDA by September 24, 2022.

Singapore I HSA (SMDR)

For medical device manufacturers, distributing medical devices in Singapore, the first phase to register its devices starts with all Coronary stents, orthopaedic joint replacement implants and Intraocular lens starts in November 2022.

Please keep in mind that timelines may change. As soon as we have updated information, we will inform you about it on our social media accounts. For more information, please feel free to send us an  e-mail.

Webinar: How to build a company-wide and global stragy for UDI

Preparing UDI data for multiple regulatory authorities in different countries is a major topic for medical device manufacturers worldwide. Keeping medical devices in a compliant state so medical device manufacturers can distribute their devices in the appropriate countries is very important to us.

We care very much about about keeping devices in a compliant state in order to ensure medical device manufacturer can distribute their devices in relevant countries.

Therefore, we will hold a webinar on November 23, 2021 at 2pm (CET) talking about how companies in the life sciences industry can prepare their processes as well as their UDI data to submit data to regulatory authorities around the world most efficiently.

Register for the webinar here.

p36 webinar: How to build a company-wide and global strategy for UDI

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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