Kristina Zvonar Brkic With the new EU Medical Device Regulation, many companies need to ensure that they are in compliance with this new regulation in order to be able to sell medical devices in the European Union.
MDR vs. IVDR comparison:
- Applicability: MDR – all medical devices; IVDR – in vitro diagnostic medical devices only
- Unique device identification: Both MDR and IVDR require a UDI number
- Pre-market data: MDR requires clinical evaluation report based on evaluation of clinical evidence; IVDR requires performance evaluation and performance studies for IVD devices
- Post-market data: MDR requires ongoing post-market clinical follow-up; IVDR requires post-market surveillance and vigilance
This can become more complicated if the In Vitro Diagnostic Device Regulation (IVDR) is also applicable to your organization, since you will need to understand how these two regulations are related as well as how they differ. In this article, we will look at the MDR and the IVDR, and compare the two regulations.
What is IVDR?
IVDR is the acronym used for the In Vitro Diagnostic Device Regulation (EU) 2017/746, which replaced the EU In Vitro Diagnostics Directive (IVDD) 98/79/EC on 25 May 2017, and is applicable specifically to in vitro diagnostic medical devices manufactured and sold in the European Union.
The IVDR regulation applies to devices that are used for the purposes of diagnosing medical issues. If you manufacture in vitro diagnostic medical devices, the date of application for IVDR, which is when all technical documentation for the medical devices is required, is May 2022. The new EU IVDR is more stringent than the previous IVDD, due to the fact that the in vitro medical device industry has changed greatly since it was released. Now, more companies will need to register with a notified body rather than self-certifying, and ensuring that your technical documentation meets all the new requirements is the first step in this change.
You can read a bit more on using ISO 13485 to meet IVD requirements in the article: How to use ISO 13485 to comply with in vitro diagnostic medical devices (IVD) requirements in the UK.
What is the new MDR?
The European Union Medical Device Regulation 2017/745, also called EU MDR, is the new EU legal requirement that applies to any medical device manufactured in or supplied into the European Union. This regulation replaces the previous Medical Device Directive (MDD), which had been in place for almost 25 years before the introduction of the EU MDR. As with the IVDR, changes in the medical device field have required changes to the EU regulations, with the EU MDR intending to improve medical device identification, and standardising data and technological advances in medical devices. The new EU MDR framework promises to be more transparent, predictable, robust and sustainable than the previous legal outline.
The EU MDR regulation comes into effect on 26 May 2021, and any MDD-certified devices must be certified according to the new EU MDR requirements by 25 May 2024, or earlier if the MDD certification ends before this date.
You can learn a bit more about the changes in the new EU MDR in the article: Infographic: EU MDR vs. MDD – What has changed?
MDR vs. IVDR comparison
One intent of the new EU IVDR regulation is to harmonise with the EU MDR regulation, particularly in the focus on supply chain control and clinical evaluation. The new EU MDR does not include regulations for in vitro diagnostic devices, leaving this to be covered by the IVDR regulation; however, EU MDR Article 1 (point 7) clarifies how the two regulations are related: this is particularly important when both IVDR components and other components are together in one medical device. Below is a comparison of some of the key aspects of MDR vs. IVDR.
You can see more on EU MDR & EU IVDR regulation implementation in the European Union’s MDR/IVDR roadmap.
EU MDR and EU IVDR: Compatible, but distinct
The most important thing to note is that the new EU MDR and EU IVDR regulations are coming into effect. If you are a medical device manufacturer for the European Union, it is critical to ensure your future compliance now before the regulations come into effect. So, it is important to now assess the medical devices that your company manufactures, assess how the EU MDR and EU IVDR regulations apply, and work early to transition to compliance with the new requirements.
To learn which documents are needed for MDR compliance, download this free white paper: EU MDR Checklist of Mandatory Documents.
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