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Implication of EU MDR Deadline on 26th May 2021

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Chalumpon Lotharukpong Created:   Nov 11, 2020 Last commented:   Nov 13, 2020

Implication of EU MDR Deadline on 26th May 2021

Given that the new implemetaion date for the EU MDR is 26th May 2021, if this is not further postponed, would it imply that CE certifcations for all devices under MDD must be recertified under MDR before being allowed to import and sell in the EU?

Is it applicable to all classes of medical device?
What happens to the products that are already in the market/ in the stores or warehouses? 
How would importer/wholesalers/end users find out if their products are CE certified under MDR?

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Kristina Zvonar Brkić Nov 12, 2020

No, all certificates issued under the MDD can be valid and products can be on the market until 26/05/2024, depending on the validity date on the CE certificate. It means if your CE certificate under MDD is valid for example until November 2023 that you can sell your product until then under the MDD. An audit that you will have prior to the expiry date in 2023 will be then conducted for MDR requirements.

This is applicable for all classes of medical devices. No single medical device can not be produced and put on the market under the MDD after 26/05/2024. 

If some medical devices issued under MDD are in the warehouse after 26/05/2024 they can be sold until May 2025.

You can see the timeline here: https://ec.europa.eu/health/sites/health/files/md_newregulations/docs/md_infographic-timeline_en.pdf

All manufacturers of medical devices are obliged to send to importers/wholesalers new certificates. It is expected that EUDAMED (database of all medical devices on the EU market) to be in place soon, so the validity of the certificates for certain medical devices will be possible to be chek even there.

For more information regarding MDR, please see the following articles:

You can also follow our webinar calendar for the free webinars on the following topics:

<Free text on MDR easy to read you can find on the following link: https://advisera.com/13485academy/mdr/

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Chalumpon Lotharukpong Nov 12, 2020

Thank you so much!
Is it still possible to apply for CE certification under MDD? If so, how long will it be valid for?

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Kristina Zvonar Brkić Nov 13, 2020

You have to check that with Notify's body. Basically, certification under MDD is possible until May 2021, but Notify bodies to have their own dates until it is possible to certify the medical devices under the MDD.

CE Certificate that will be issued before May 2021 under the MDD is valid until 26/05/2024. 

However, be aware that periodic audits that will be performed after May 2021 – therefore period audits that will be performed under the MDR – will require certain documentation to be ready according to the MDR requirements. First of all, this refers to the Post-market surveillance system. This process needs to be in place in accordance with the MDR requirements on the first periodic audit. It means the following for example: if you receive an MDD audit in April 2021, your first-period audit will be in April 2022. On that periodic audit, your post-market surveillance system must be in place according to the MDR requirements.  

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