What Is the Difference Between MDR and IVDR?
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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 medical device regulations.
However, meeting these compliance requirements is not an easy task. From clinical evaluation to technical documentation and submission of reports, the entire process of compliance 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.
MDR Versus IVDR Regulation
At first glance, the two sets of device 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 device regulations may be considered two sides of the same coin.
Applicability
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 (In Vitro Diagnostic Regulation) 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.
Pre-Market Data
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 to ensure the quality of the device and that it is in compliance with the regulation.. On the other hand, IVDR requires performance evaluation and performance studies of the IVD device as part of the CE technical file.
Post-Market Data
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.
Notified Bodies
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.
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IVDR
Which Countries Does IVDR Apply To?
The Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) apply to all organizations engaged in device manufacturing within the European medical research, healthcare, and analysis markets. The core objective of the IVDR requirements is to improve safety standards and risk management across the medical devices deployed for use in the EU.
However, it is equally essential that device manufacturers located outside of the EU understand compliance rules and can adhere to the compliance requirements since this is necessary for any manufacturer placing an IVD in the EU market or collaborating with EU-based partners.
What Does EU IVDR Replace?
IVDR is a newer regulation applicable to all manufacturers or healthcare services previously subject to the In-Vitro Diagnostic Medical Devices Directive, abbreviated to ‘IVDD.’ The revised IVDR compliance requirements were approved in 2017 as the beginning of a five-year transition phase away from the IVDD.
This new medical device regulation is designed to improve the safety, reliability, and quality standards of all in-vitro devices used throughout Europe and impact the management, development, and regulation of affected devices across the lifecycle of device design, marketing, and distribution.
Where Can I Get More Information About IVDR?
The DistillerSR team is on hand to help any affected business learn about IVDR system standards, manage their clinical evaluation processes, and ensure they adhere to all quality, risk management, and declaration requirements applicable to IVDR products, device types, and associated research systems and protocols.
When Was the IVDR Implemented?
Following approval in 2017, the IVDR was officially implemented in May 2022. Previously approved devices must demonstrate compliance with the requirements by this date. However, caveats apply in certain circumstances where businesses may be eligible for an extended transition, depending on the class of the devices or reagents they manufacture.
IVDs may be entered into the extended transition phase, permitted in Regulation (EU) 2022/112, if they fall into a specific risk class. At the latest, they must produce a fully compliant Conformity Assessment by May 2027.
What Does ‘IVDR’ Stand For?
‘IVDR’ is the acronym used for the In-Vitro Diagnostic Device Regulation, approved by the European Council and European Parliament in 2017 and introduced into regulatory requirements in 2022.
The revised in-vitro diagnostic regulation affects the second-largest global medical device market. It is a major step-change for device manufacturers, changing how producers can apply for CE Marking and access the EU market with a new classification system and rules for previously self-certified devices.
What Are IVDR Devices?
Devices used for in-vitro diagnostics are subject to IVDR regulation. They can include medical devices for genetic testing, neonatal screening, bloodwork analysis, and any device that is a reagent or reagent product.
Around 90% of IVDs currently available through the EU market and adherent to previous IVDD rules will require a Notified Body Conformity Assessment to remain valid and permissible, using a new classification system based on risks categorized from Class A for devices with low patient and public health risks, to Class D for devices associated with higher risks for both groups.
Final Takeaway on Medical Device Regulation
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 device regulations, they differ significantly in the nature of the products they cover, their applicability, and overall in the compliance requirements. When comparing the MDR vs IVDR, the IVDR has a longer implementation period and affects a smaller product range.
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