Are you trying to figure out your required schedule for certifying your medical devices under the updated European Medical Device Regulation or EU MDR (2017/745)? Don’t worry, we got the answers right here! In partnership with MDR Consultants, here are a few pointers on how to find the answers.  

The Basics

Let’s start with the basics. The risk class of your device and your chosen route of conformity affects your next steps. 

Class 1 devices without a measuring function, that are not sterile, or aren’t reusable as classified under both MDD (Medical Device Directive) and MDR should have been in conformity to the provisions of the regulation by the date of application (May 26, 2021).

Risk Classes & Conformity

Medical devices, except those mentioned before, that have been certified under the MDD and that require notified body involvement under the MDR, can continue to be put on the market or into service until the date of expiration of their certificate or until May 2025, whichever comes first, as long as they continue to conform to the directive, have not had any significant changes to their design or intended use, and their declaration of conformity have been issued before May 26, 2021.  

These devices shall be certified under the EU MDR on or before the date of expiration of the certificate but no later than May 2024. They should also have a quality management system governing them in compliance with the provisions of the regulation related to market surveillance, post-market surveillance, vigilance, registration of devices, and registration of economic operators on or before the date of application of the regulation (May 2021). Products certified under Annex 4 under the MDD are no longer valid (expired on May 27, 2022) and should have been recertified under the new regulation.  

All certificates issued under the MDD will now be void on the date of expiration of the certificate but no later than May 27, 2024. However, remember that all products requiring notified involvement under the MDR can continue to be put on the market or into service until May 26th, 2025. On May 27th of 2025, all devices with voided certificates will need to be withdrawn until proper CE marking under the EU MDR is achieved. 

New Requirements

With those dates 2 to 3 years away, you may think you have plenty of time to certify your devices. However, that isn’t quite the case. Think about all the new requirements that the conformity assessment process under the EU MDR has.  This includes but is not limited to the following: 

  1. Reclassification
  2. Determining the route of conformity
  3. Selecting a notified body with the correct designation codes
  4. Reviewing and updating the QMS
  5. Determining applicable general safety and performance requirements
  6. Updating and documenting the technical documentation
  7. Remediating supporting evidence used for compliance against state-of-the-art
  8. Updating the information provided with the device to include the organization’s website
  9. Generating the declaration of conformity
  10. Updating and remediating all agreements with both the supply chain as well as the distribution chair
  11. Assigning responsibilities within the organization to ensure continued compliance
  12. Submitting requested documentation to the notified body for review
  13. Requesting and performing assessment audits with the notified body

Multiply several of the tasks by the number of devices, group of devices, or device categories your organization has and you realize this will not take a few months, it will take years to complete.

for EU MDR

The deadline to transition to the EU MDR is May 26, 2024.
Are you looking for information on how to start the transition
or how to best structure your organization?

Reliant Life Sciences has partnered with MDR Consultants
and Isabel Osorio to offer hands-on training.
To learn more and to sign up, please visit their website.

Important Deadlines

The timeline can be a bit confusing. Here are a few pointers on how to find the registration date for your products.