What Is the Main Purpose of the MDR?
The European Medical Device Regulation (EU MDR) comprises a regulatory framework that ensures a high level of safety and efficiency for all medical devices sold in the European market. However, the process of MDR evaluation and compliance is extensive. Among other things, it requires a CER literature review and a written clinical evaluation plan based on all current clinical evidence for a given device. This in itself can seem like a Sisyphean task, but using AI automated software, such as DistillerSR, can make it easier and faster for medical device companies to complete the EU MDR and IVDR notified body submissions.
In this article, we’ll dive into the main purpose of the MDR, what the EU MDR is, and the differences between MDR and IVDR.
Purpose of the EU MDR
The EU MDR was introduced via Regulation (EU) 2017/745, as a reaction to scandals involving defective medical devices. By tightening the requirements for medical devices, the MDR’s main aim is to ensure the safety and effectiveness of medical devices on the European market are thoroughly vetted and protected. EU MDR replaces previously applicable national directives, specifically the Medical Device Directive or MDD, thereby contributing to the harmonization of rules and regulations in Europe.
The main objectives of the MDR are as follows:
- Increased protection of patient safety
Better control and accessibility of technical documentation
Greater transparency and traceability of medical devices
To achieve its objectives, the MDR has introduced the following aspects:
- New classification rules for medical devices
- Stricter requirements for clinical evaluation, technical documentation, postmarket surveillance, and the vigilance system
- More comprehensive labeling of medical devices with the introduction of a UDI code and reporting of device data to the European Database EUDAMED
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What Is the EU MDR?
Although the Medical Device Directive (MDD) and the Active Implantable Medical Devices Directive (AIMDD) were introduced in the 1990s and helped advance the medical device market in Europe, regulators were concerned that these directives did not address many evolving safety trends effectively. Significant technological and scientific developments in the medical device industry have required stricter and comprehensive regulations to govern the production and sale of medical devices. As a result, the European Union Medical Device Regulation (EU MDR) and In Vitro Diagnostic Regulation (IVDR) were approved in March 2017 by the European Council and in April 2017 by the European Parliament. Both regulations entered into force on May 26th, 2020, and May 26th, 2022, respectively.
The EU MDR is an entirely new set of regulations that outline directives and rules for the production and sales of medical devices in Europe. The MDR document contains 174 pages, including a twelve-page introduction, 123 articles, and seventeen annexes. Additionally, there are forty-two implementing acts that further clarify the MDR and twelve delegated acts that modify and amend the regulation. As a result of the more rigorous requirements outlined in EU MDR, as well as the comprehensive changes the legislation imposes, medical device manufacturers have struggled across the board to meet the revised guidelines, within the timeframes proposed.
How Is the MDR Different From IVDR?
IVDR, which is an acronym for in-vitro diagnostic device regulation, specifically governs the sales and production of in-vitro diagnostic medical devices in Europe. This set of regulations applies to devices used to diagnose medical issues. The EU MDR and IVDR are different regulations, each with its own thresholds and substance lists 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 this scope, as do some products that are used in contact with patients but are not intended to be used for medicinal purposes.
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 device classifications are different in the EU MDR and IVDR guidelines. In addition, compared to the EU MDR, the IVDR has a longer implementation period and affects a smaller product range.
The EU MDR is a comprehensive and detailed set of regulations introduced to govern the sales and production of medical devices in Europe. These regulations set a high standard for the quality and safety of medical devices to better address the safety concerns of medical devices. Compliance with MDR is mandatory for medical device companies that intend to sell their products in Europe.