MDR Extension: Key Takeaways
You may have heard the EU Medical Device Regulation (EU MDR) date of application is being delayed one year, but might be wondering what it really means. For some this is welcome news and allows more time to get ready, for others it doesn’t change much. The vote to delay was approved by an overwhelming margin on April 17, 2020 and the amendment was published in the Official Journal of the European Union on April 23, 2020.
This delay of the EU MDR date of application comes as a positive development for our industry during these unprecedented times. The new date of May 26, 2021 has been established by the European Parliament and Council in an amendment to the original regulation. This also means the repeal of the Medical Device Directives (90/385/EEC and 93/42/EEC) is delayed by one year.
The following are key takeaways regarding the details from the amendment:
- This only applies to the Medical Device Regulation. There is no change to the In Vitro Diagnostic Regulation (2017/746).
- The regulatory requirements of the regulation itself have not been amended. The requirements remain the same for Medical Device Manufacturers, Notified Bodies, Authorized Representatives, Importers and Distributors.
- There are no changes to the transition dates for CE Mark certificates under the previous EU Medical Device Directive. The Medical Device Directive certificates will still expire no later than May 26, 2024, and devices in service or already on the market as of May 26, 2021 may continue to be made available until May 26, 2025.
- There are updates to Article 59, Derogations from the conformity assessment procedures. This pertains to exceptions to the rules for conformity assessments that allow non-CE marked products deemed of ‘humanitarian use’ to be used for the good of public health. The amendment also now specifically references the corresponding Articles in the MDD (Article 11.13) and AIMD (Article 9.9). By including these references to the directives, the derogations adopted under the directives may apply or be extended using Implementing Acts once the May 26, 2021 date of application is reached.
- There are updates to Article 120, Transitional provisions. The amendment now includes Class I devices with declaration of conformity prior to May 26, 2021, and for which an assessment to the EU MDR requirements would require a notified body. The transition dates remain the same, but now clearly includes these Class I devices, aligned with guidance previously published by the Medical Device Coordination Group (MDCG).
- Article 122, Repeal, has been updated to align the repeal of the directives with the date of application of the new EU MDR.
- Article 123, Entry into force and date of application, introduces new staggered implementation dates for Unique Device Identification (UDI). Specifically, for reusable devices which bear the UDI carrier on the device itself, the new dates are as follows: May 26, 2023 for implantable devices and class III devices; May 26, 2025 for class IIa and class IIb devices; May 26, 2027 for class I devices.
There is some confusion about the impact of the delay in the Date of Application with the already announced delay in the implementation of the Eudamed database. Article 34, which pertains to the Functionality of Eudamed, has been updated to reference the May 26, 2021 date. However, the date in Article 34 is not necessarily the date by which Eudamed is required to be functional. Unless further guidance is provided by the MDCG, the implementation of Eudamed is still expected in May, 2022, as previously announced. This corresponds with the implementation date of the EU IVDR.
With these changes comes a significant opportunity for manufacturers to use this time wisely and not take their foot off the gas when it comes to EU MDR preparedness. Being ready for quality and regulatory compliance will give companies an edge over their competitors and reduce the risk of products being taken off the market. Many companies were struggling to fully meet the deadline and will be able to use the additional time to be truly ready.
At Maetrics, we are successfully supporting clients with effective remote teams as they prepare to meet the EU MDR requirements. We partner with companies to thoroughly assess and remediate their technical documentation and quality management systems. The EU MDR has increased requirements for Clinical Evaluations and other Technical File documentation, which now also includes new Post Market Surveillance documentation. The additional time can also be used to properly evaluate and confirm Economic Operator relationships and agreements. The clarification in UDI timelines also allows for more robust planning and implementation.
Contact us if you have questions about the EU MDR requirements, this new update or your compliance planning.
Have a Question?
Contact us to learn more & find out how Maetrics can solve your regulatory or compliance issues.