Kristina Zvonar Brkic Updated: September 19, 2023.
The need for new regulations for medical devices and in vitro medical devices was driven by changes in the industry and the need to improve patient safety. The previous regulations were outdated and did not adequately address the risks associated with these devices. The new EU Medical Device Regulation (MDR) and In Vitro Diagnostic Device Regulation (IVDR) aim to improve medical device identification, standardize data, and incorporate technological advances.
The IVDR is more stringent in regulating in vitro medical devices, which are used for diagnosing medical issues. The new regulations MDR and IVDR ensure that medical devices are safe, effective, and meet the highest standards of quality and performance. In this article learn more about IVDR meaning and the difference between IVD and medical device regulations.
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
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 EU 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 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?
What is the difference between MDR and IVDR
The MDR and in vitro diagnostic regulation for the EU may seem similar in their structure and chapters, but there are notable differences. The MDR has 123 articles, making it slightly more extensive than the IVDR with 113 articles.
The main differences between MDR and IVDR are applicability, pre-market data requirements, and post-market data requirements. MDR applies to all medical devices for human use, while IVDR only applies to in vitro diagnostic medical devices that are manufactured or sold in the EU. MDR requires a clinical evaluation report based on evaluation of clinical evidence as part of the CE technical file, while IVDR requires performance evaluation and performance studies specifically for IVD devices. For post-market data, MDR requires ongoing post-market clinical follow-up, while IVDR requires post-market surveillance and vigilance.
Below is a comparison of some of the key aspects of MDR vs. IVDR.
EU MDR vs. EU IVDR comparison
| EU MDR | EU IVDR | |
| Applicability | All medical devices for human use that are manufactured or sold into the European Union | In vitro diagnostic medical devices only, that are manufactured or sold into the European Union |
| Unique device identification | UDI number is required on devices | UDI number is required on devices |
| Pre-Market Data | Require clinical evaluation report based on evaluation of clinical evidence, which becomes part of the CE technical file | Require performance evaluation and performance studies for IVD devices, which becomes part of the CE technical file |
| Post-Market Data | Requires ongoing post-market clinical follow-up | Require post-market surveillance and vigilance |
| Notified Bodies | Applicable to most classes of medical devices | Greater applicability to more in vitro diagnostic devices |
You can see more on EU MDR & EU IVDR regulation implementation in the European Union’s MDR/IVDR roadmap.
MDR and IVDR: Compatible, but distinct
The EU MDR and IVDR are separate and distinct regulations, each with their own thresholds and substance lists that are applied to different types of products. While the MDR applies to all medical devices for human use that are manufactured or sold into the European Union, the IVDR only applies to in vitro diagnostic medical devices that are manufactured or sold into the European Union.
Manufacturers of both medical devices and in vitro diagnostic devices need to ensure that they are in compliance with the new EU Medical Device Regulation (MDR) and In Vitro Diagnostic Device Regulation (IVDR) in order to sell their products in the European Union. The new regulations aim to improve medical device identification, standardize data, and incorporate technological advances, ensuring that medical devices are safe, effective, and meet the highest standards of quality and performance. It is important for manufacturers to understand the differences between the MDR and IVDR regulations, as well as how they are related, in order to meet all necessary requirements.
To comply with all EU MDR requirements, use this helpful ISO 13485 & MDR Integrated Documentation Toolkit that provides all documents for medical device companies.
