Dear reader,

All of us currently live in uncertain times as the coronavirus pandemic presents us with unprecedented challenges.
For this reason, the European Parliament has agreed to postpone the Date of Application of the EU MDR to 26 May 2021.

However, not all transition periods and expiration dates are postponed, and other regulatory authorities will soon be issuing their own medical device / UDI guidelines. We therefore recommend to not discard all EU MDR projects but to use the additional time to create an intelligent and strategic setup for UDI.

To keep you up to date, we have prepared this regulatory update which contains an updated overview of EU MDR and upcoming key actions of regulatory authorities in other markets.

Stay healthy and confident!

Best regards
Patrick Pfau

 

EU MDR overview

MDR Date of Application postponed by one year

Updated Timeline for EU MDR / IVDR

Global regulatory overview

Global Timeline

Spotlight: SFDA UDI requirements and timeline

 


„In order to ensure the smooth functioning of the internal market, a high level of protection of public health and patient safety, to provide legal certainty, and to avoid potential market disruption, it is necessary to defer the application of certain provisions of Regulation (EU) 2017/745 by one year.“

(Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulation (EU) 2017/745 on medical devices as regards the dates of application of certain of its provisions / April 2020)

 

EU MDR overview

MDR Date of Application postponed by one year

Given the current pressure on national health authorities and manufacturers of medical devices due to the coronavirus pandemic, the EU Commission released a proposal to postpone the Date of Application of the European Medical Device Regulation (EU MDR) 2017/745 by one year until 26 May 2021.
The EU Parliament adopted the Commission proposal on April 17 allowing authorities and manufacturers alike to prioritise the fight against the coronavirus pandemic by continuing under current procedures.However, not all transition periods and expiration dates are postponed by one year, but remain with the known dates. In the worst case, this means that even more manufacturers have to obtain certification in less time. Therefore, the proposal revised by the Council provides that willing manufacturers and notified bodies will be able to apply the MDR as far as possible from May this year.

 

The following list provides the main aspects affected by the postponement:
  • The MDR generally applies from May 26, 2021 (Article 123 (2)).
  • The MDD and AIMD will not be waived until May 26, 2021 (Article 122), with the exception of vigilance requirements, the availability of documents and the exceptions mentioned.
  • Manufacturers and notified bodies who already want to obtain certification or notification according to MDR can do this earlier – and earlier in this case means before May 26, 2021 (Articles 120 (5) and (6)).
  • Publication of the communication on the functionality of the EUDAMED database and compliance with the associated deadlines by the EU Commission postponed to March 25, 2021 (Article 34).
  • Depending on the functionality of EUDAMED, the obligations and requirements in connection with EUDAMED are only valid from May 26, 2021 or 6 months after the announcement (Article 123 (d)).
  • Clinical studies according to MDD or AIMD may begin until May 26, 2021; reporting of serious adverse events and product defects in accordance with MDR must also only take place from May 26, 2021 as part of these studies (Article 120 (11)).
These aspects remain unchanged:
  • No extension of validity of certificates according to MDD and AIMD – the expiration date remains May 2022/2024 at the latest (Article 120 (2)).
  • The provision and commissioning of products that have been placed on the market according to MDD or AIM may still only take place by May 26, 2025 at the latest (Article 120 (4)).
  • No postponement of the deadline for attaching the UDI carriers to the product label and the higher packaging levels in accordance with Article 27 (4) of the MDR (Article 123 (f)).
  • No postponement, but a clearer wording for the deadlines for applying the UDI to reusable products depending on their classification (Article 123 (g)).
As you can see, the postponement of the MDR primarily serves to ensure the supply of critical medical devices and is intended to relieve the EU and the member countries in particular from the current situation. Manufacturers must nonetheless have switched to an MDR certificate by May 2024 before their MDD / AIMD certificates expire.

 

Updated Timeline for EU MDR / IVDR

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

We recently received information that the actor registration module is about to be made available no later than March, 2021 and also the UDI / Device module shall be made available in May, 2021 for voluntary submission of UDI / Device data. Therefore, we recommend to not discard all EU MDR projects but to use the additional time to create an intelligent and strategic setup for UDI.

We would be happy to support you actively and would like to offer you a workshop for an UDI Gap Assessment in which we analyze your existing UDI related processes and provide advice on how to build/enhance your strategic UDI setup.

Please contact us if you are interested in an UDI Gap Assessment workshop or how we may support you with regard to securing worldwide UDI compliance.

 

Global regulatory overview

UDI is a global challenge, so keeping an eye on other markets is imperative.
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.

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. A Machine-2-Machine interface is planned to be made available for submission of UDI data.

The Saudi Arabian SFDA released guidance on UDI in April 2019 and started a first test phase for UDI data entry into the SAUDI-D database, an extended second test phase is planned.

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:

 

Spotlight: SFDA UDI requirements and timeline 

The Saudi Arabian SFDA is currently establishing its UDI database SAUDI-D, the requirements of which are in alignment with the IMDRF guidelines and adopt the US FDA and EUDAMED concepts.

The Basic UDI-DI concept known from the EU MDR will also be integrated. As the main key in SAUDI-D, the Basic UDI-DI will be mandatory for relevant documentation (e.g. certificates, declaration of conformity, technical documentation and summary of safety and clinical performance). 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.

Furthermore, labeling will be required.

As soon as SAUDI-D becomes available, Class D will become applicable 6 months later, Class B and C one year after availability and Class A two years after availability from Saudi-D.

UDI Platform – one solution for all UDI databases

We offer the strategic answer for your UDI challenge with the UDI Platform.

The UDI Platform enables you to cover regulatory requirements on Unique Device Identification of regulatory authorities worldwide with one end-to-end workflow-based UDI data governance and submission solution – fast, flexible and easy to use!

 Visit us for more information or view the video below!

 

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