What does EU MDR mean?
The EU MDR is the European Union Medical Device Regulation 2017/745 that were released in 2017 by the European Parliament and the Council of the European Union. The intent of the EU MDR regulations is to ensure a high standard of safety and quality for medical devices that are produced in, or supplied to, member countries of the European Union.
This regulatory framework is intended to better identify medical devices, as well as standardizing data and technological advances through an EU database (Eudamed). The regulation EU MDR is intended to be a regulatory framework for medical devices that can sustainably ensure health & safety while still encouraging innovation.
What is MDD and MDR?
The European Union Medical Device Directive (MDD) had been in place for almost 25 years before it was replaced by the new European Union Medical Device Regulation (MDR), issued in 2017. This previous directive constituted the EU framework for medical devices, but it did not include in vitro diagnostic medical devices.
However, it was determined that a fundamental revision of those directives was necessary to establish a more robust, transparent, sustainable, and predictable regulatory framework. The intent was to improve the overall level of health and safety of medical devices, while still supporting innovation in the industry.
When was EU MDR published?
While the council of April 4, 2017, on European medical devices was responsible for the creation of the new regulations, the EU MDR regulation was published on May 5, 2017. There is a three-year transition period for companies to comply with the new MDR EU regulation.
When does EU MDR go into effect?
While companies can start to comply with the new regulations immediately, the transition period from the EU MDD directive to the EU MDR regulations lasts for a four-year period and ends on 26 May 2021. After this date, any new medical devices will need to be certified to the new EU MDR regulations. Existing MDD-certified medical devices have an additional transition period until May 2024 to change their technical documentation to comply with the new MDR EU regulations.
Which date must all existing MDD certified devices be certified under the MDR?
The final date for all MDD-certified devices to be certified under the new MDR is May 25, 2024. If a medical device is compliant with the EU MDR regulations before this date, then it can be certified under the MDR, but it is not mandatory if its MDD certificate is still valid. If the MDD certificate expires before 25 May 2024, then such medical device needs to be recertified according to the MDR.
The last date to make this final certification according to the EU MDR is May 25, 2024 – after this date, all devices placed on the market must be certified under the EU Medical Device Regulation.
What is EU MDR compliance?
The EU Medical Device Regulation has established a unique device identification (UDI) system that is similar to the United States Food and Drug Administration (FDA) system. If a company intends to provide or distribute medical devices into the EU marketplace, the labeling on those products will need to comply with this new UDI system. Compliance with the new MDR regulation is mandatory for medical device companies that intend to sell products in Europe.
What is MDR certification?
MDR certification of a medical device verifies that the device meets all of the regulatory requirements for European Union medical devices; the certification is indicated by a CE Mark.
In order for medical devices to be certified, your company must implement a Quality Management System (QMS). Many companies use ISO 13485 as a way to implement this QMS, as this is the only QMS standard on the EU harmonized lists, and therefore it is the best way to implement the QMS as it relates to the MDR EU regulation.