EU IVDR Requirements
General Background
The In Vitro Diagnostic Regulation (IVDR) is a regulation of the European Union (EU) that sets out the rules for manufacturers of in vitro diagnostic medical devices (IVDs) to follow in order to place their products on the EU market.
More stringent regulations as per public safety and patient safety for IVD products, before being placed in market for human use.
This documentation includes:
In terms of:
- General safety and performance requirements of IVD devices
- Performance evaluation
- Clinical report
- Risk management
- Vigilance
- Harmonization
The 157-page regulation entered into force on May 25th 2017, replacing the EU’s directive on In Vitro Diagnostic Medical Devices (98/79/EC) in order to regulate the use, distribution, and handling of medical devices that provide information about human samples (for example blood and tissues) which can lead to possible concisions about physiological and pathological processes. The scope of IVD devices covered under the regulation is significantly expanded and many devices have been reclassified.
This documentation includes:
Transition arrangements may apply to certain manufacturers in accordance with Article 110 of EU IVDR:
- Class D - IVDs May 26, 2025
- Class C - IVDs May 26, 2026
- Class B - IVDs May 26, 2027
- Class A IVDs placed on the market in sterile condition - May 26, 2027
- Non-sterile self-declared devices or new devices to EU market - May 26, 2022
Support & Training
Contact AKRA TEAM for support, hands on implementation services and personalized training by experts with key competencies in the areas listed below.
Key considerations for manufacturers under the EU IVDR include:
The EU IVDR classifies IVDs into four classes based on their level of risk to patients and users. Manufacturers need to determine the appropriate classification of their IVDs to ensure compliance with the regulation. Unlike the previous directives, Article 47 and Annex VIII of EU IVDR now classify medical devices into four categories: A, B, C, D, depending on their intended purpose and their risks:
- Class A: Products for laboratory purpose and specimen receptacles
- Class B: Self testing devices determining cholesterol, glucose and pregnancy tests.
- Class C: Screening congenital disorders in embryo, fetus and new-born babies, cancer diagnosis and Blood grouping, self-testing devices except class B
- Class D: ABO, Rhesus, Kell, Kiddy, Duffy system. Transmissible life-threatening high risk.
Software and Calibrators intended to be used with a device, shall be classified in the same class as the device. If several classification rules apply to the same device, the rule resulting in higher classification shall apply.
Manufacturers need to perform a performance evaluation of their IVDs to demonstrate scientific validity, analytical performance and clinical performance. The clinical evidence derived from the performance evaluation shall provide scientifically valid assurance, that the relevant general safety and performance requirements are fulfilled, under normal conditions of use.
This evaluation must be conducted according to the requirements set out in Article 56-60 the EU IVDR, including the use of appropriate study designs, statistical methods and updated throughout the life cycle of the device.
Manufacturers must develop and maintain technical documentation that demonstrates compliance with the EU IVDR. This documentation must include information on the:
- Device Description & Specification
- Information Supplied by the Manufacturer
- Design & Manufacturing Information
- General Safety & Performance Requirements
- Benefit–Risk Analysis & Risk Management
- Product Verification & Validation
- Technical documentation on post-market surveillance (Annex III)
More stringent requirements are in place for technical documentation and scrutiny from the Notified Body. The EU IVDR requires device manufacturers to conduct clinical performance studies and provide evidence of safety and performance proportionate with the risk class of the device.
Manufacturers must establish a system for post-market surveillance of their IVDs to monitor performance and identify any issues that may arise. This system must include procedures for reporting adverse events and implementing corrective and preventive actions.
The difference in the EU IVDR scope and classification requires the involvement of a Notified Body for the approval of all but Class A non-sterile devices. Approximately 90 percent of all IVD devices will be subject to Notified Body review, compared with less than 15 percent currently.
Overall, compliance with the EU IVDR requires significant resources and expertise from manufacturers. It is important for manufacturers to start the compliance process early and to work closely with their notified body and other stakeholders to ensure a smooth transition to the new regulation.
Our Services
Training
AKRA TEAM can provide manufacturers with the necessary training package for the organization´s specific EU IVDR competency needs.
Manufacturers can request trainings and workshops in selected topics and/or general EU IVDR training.
Process and Templates Development
Contact AKRA TEAM to provide the necessary EU IVDR compliant templates and/or finalized documentation. AKRA TEAM provides the right experts to create and maintain parts of your technical documentation such as the PERs and SSPs, as well as QMS documentation such as SOPs for Post Market Surveillance, Vigilance and Reporting, Complaint Handling, Risk Management and more, which are necessary for an EU IVDR compliant QMS.
Gap Assessment
AKRA TEAM provides services to evaluate and assess quality, completeness, and conformity of the relevant documents. Documentation will be compared against EU IVDR requirements or feedback from the notified bodies to ensure conformity of the product(s). A detailed gap assessment will be presented to the customer.
Implementation
AKRA TEAM provides hands on implementation support. The Team´s consultation and guidance ranges from providing strategic regulatory guidance and explanation of pathways their consequences to onsite and/or virtual intensive and daily collaboration with the manufacturer´s relevant employees to achieve preset goals.
Continuous update of documentation
Once EU IVDR compliant documentation has been implemented and submitted to the Notified Body, it may require continuous update due to requirements such as for PMS or due to any other changes triggered by the regulators, the market, the data on the device or by the manufacturer itself. AKRA TEAM will ensure follow-up and can accompany manufacturers to maintain compliance.
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