What Is the Difference Between MDR and IVDR?
The medical device market in Europe is growing at a rapid pace. Introduced in the nineties, the Medical Device Directive (MDD), the Active Implantable Device Directive (AIMDD), and In-vitro Diagnostic Device Directive (IVD) have helped create governance around this market. But with significant scientific and technological advancements, there was a need to come up with a more comprehensive and strict set of regulations to govern the production and distribution of medical devices. As a result, the European Union Medical Device Regulation (EU MDR) and In-vitro Diagnostic Device Regulation (IVDR) were approved in March 2017 by the European Council and in April 2017 by the European Parliament. MDR entered into enforcement on May 26th, 2020, and IVDR on May 26th, 2022. The MDR aims to guarantee the safety and effectiveness of medical devices in the European market. It is mandatory for all companies intending to sell their products in Europe to comply with these regulations.
However, meeting these compliance requirements is not an easy task. From clinical evaluation to technical documentation and submission of reports, the entire process is extremely arduous. However, using AI automated software such as DistillerSR to help with aspects like CER literature search can save companies valuable time and effort while ensuring all requirements are met using clearly auditable processes.
Wondering how often a CER should be updated? Check out our recent article.
What Are MDR and IVDR?
The EU MDR is a set of directives and rules that govern the production and distribution of medical devices in Europe. Similarly, the IVDR governs the sales and production of in-vitro diagnostic medical devices in Europe.
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MDR Versus IVDR
At first glance, the two sets of regulations may seem similar in their structure and chapters. However, with 123 articles, the MDR is slightly more extensive than the IVDR with 113 articles. They are different regulations, each with its own thresholds and substance lists that are applied to different types of products. While some confusion may arise from EU MDR’s application to certain diagnostic devices, these separate regulations may be considered two sides of the same coin.
EU MDR applies to medical devices that come into direct contact with humans. It covers everything from bandages and catheters to implants and colored contact lenses; certain diagnostic and monitoring devices also fall under its scope.
Contrary to the EU MDR, the IVDR covers medical devices that perform an in vitro function. The list of in vitro diagnostic products (or IVDs) covered under the IVDR is vast, but most take biological specimens from within the body and analyze the specimens outside of the body. Common IVDs include pregnancy tests, laboratory equipment, calibrators and instruments, specimen receptacles, blood tests, urinalysis kits, COVID-19 tests, and cholesterol tests, to name a few.
The EU MDR requires a clinical evaluation report of the medical device, which is based on the evaluation of all available clinical evidence, to be submitted as part of the CE technical file. On the other hand, IVDR requires performance evaluation and performance studies of the IVD device as part of the CE technical file.
While the MDR requires a continuous post-market clinical follow-up of the medical device, the IVDR requires post-market surveillance and vigilance of the IVD device. In addition, the two regulations require some different post-market surveillance deliverables to ensure a fully compliant PMS system.
The MDR is applicable to most medical devices, such as class IIa, IIb, and III. The IVDR has greater applicability to classes B, C, and D IVD devices.
Both EU MDR and IVDR regulations aim to improve the safety and performance of medical devices in Europe, providing a high level of protection for the health of patients and users of these medical devices. One intent of the IVDR is to harmonize regulations with the MDR, particularly in the focus on supply chain control and clinical evaluation. Although there are similarities between the two regulations, they differ significantly in the nature of the products they cover, their applicability, and overall in the compliance requirements. Compared to the EU MDR, the IVDR has a longer implementation period and affects a smaller product range.