EU Medical Devices Regulation Latest Amendments were published on March 20, 2023. What’s new and important for compliance issues?
What is the MDR?
Regulation (EU) 2017/745, also known as the Medical Devices Regulation (MDR), is a European Union regulation that sets out rules for the safety and performance of medical devices. The MDR came into force on May 25, 2017, and the transition period ended on May 26, 2021.
What is new from March 20, 2023?
In regard to Regulation (EU) 2017/745, paragraphs 2, 3 and 4 of article 120 have been revised. Furthermore, there are changes in articles 122 and 123. In regard to Regulation (EU) 2017/746, articles 110 and 112 are amended.
All amendments can be read in the official publication of the EU.
Why is it constantly revised?
Since its adoption, there have been several amendments made to the MDR, including:
- Delay of application: Due to the COVID-19 pandemic, the European Commission postponed the application of the MDR by one year, until May 26, 2021.
- Extension of transitional period: In light of the significant challenges faced by the medical device industry in implementing the MDR, the European Commission extended the transitional period for certain medical devices until May 26, 2024.
- Implementation of the Eudamed database: The Eudamed database is a central repository for information on medical devices in the EU. The implementation of Eudamed has been delayed several times, and its launch is now scheduled for May 26, 2022.
- Clarification of the scope of the MDR: The European Commission issued guidance to clarify the scope of the MDR, particularly regarding the definition of medical devices and the distinction between medical devices and other products.
- Amendments to the conformity assessment procedures: The MDR introduced new conformity assessment procedures for medical devices, and the European Commission has made several amendments to these procedures, including the adoption of new guidance documents.
- Changes to the classification rules: The MDR introduced new classification rules for medical devices, and the European Commission has made several changes to these rules, including the reclassification of certain medical devices.
Overall, these amendments are intended to improve the safety and performance of medical devices in the EU and to provide greater clarity for medical device manufacturers, regulators, and other stakeholders.
What causes this particular amendment?
There is a looming shortage of medical supplies. This may cause a public health crisis. This regulation takes effect as a matter of urgency. This is for the following reasons:
- achieving the intended effect of the amendments to Regulations (EU) 2017/745 and (EU) 2017/746;
- ensuring the availability of devices whose certificates have already expired or will expire before May 26, 2024;
- providing legal certainty for economic operators and healthcare providers;
- for the sake of consistency with the amendments of both regulations mentioned above
What to do when you have applied standards to prove compliance?
Do you have applied standards to prove compliance in regard to the mentioned regulation? We recommend you to check the new list of standards to see if any of the standards you applied have been updated. If so, you need to re-evaluate your products against the updated standard and update your Technical Files.