What Are the New Regulations for In-Vitro Diagnostics

The new Medical Devices regulation for In-Vitro Diagnostic also known as In-Vitro Diagnostics Regulations (IVDR) was adopted by the EU in April 2017 and came into force in May 2017. The application dates of these regulations are in place from May 26th, 2022 for IVDR. The following blog will cover the topics related to IVDR devices, the classification of such devices, the documentation requirements for them, and the impact of IVDR on the lab-developed tests

The IVDR (EU) 2017/746 establishes a new regulatory framework for in-vitro devices such as HIV tests, pregnancy tests, and SARS-COV-2 tests. It is estimated that 70% of clinical decisions are made using IVD devices.

The main objectives of the IVDR are:

  1. Promote patient safety.
  2. Promote free and fairtrade among IVD Medical Devices manufacturers
  3. Foster consistent innovation and competitiveness among IVD medical device manufacturers
  4. Enhance harmony through EU member nations.
  5. To increase the involvement of notified bodies for IVD devices.

IVDR Classifications

Even though the IVDs have retained a residue of the old system (similar to the FDA regulations), new medical device regulations came with a classification system of the IVDR that was based on specific rules. IVDR establishes four risk classes A, B, C and D - with D being the highest risk class and A being the lowest risk class. Annexx VIII identifies seven different classification rules of IVDS however this blog will focus on only four major classes. 

  • Class A: Covers mostly laboratory devices, instruments and specimen receptacles. These often present a low public health risk and low individual patent risks

  • Class B: This covers all patient testing devices that prevent lower risks to the patient and the population at large. These can be self-testing IVD devices for pregnancy and fertility testing as well as detection of cholesterol levels and detection of glucose, erythrocytes, leucocytes and bacteria in the urine. These devices present a low public health risk and are used to moderate individual patient risks

  • Class C: This classification covers a mix of high-risk IVD devices that present less risk to the wider population. Testing patients using these IVDs means that there is a life-threatening situation and without using this, the patient might be in danger. This would include, testing for infectious diseases and cancer. This classification also includes companion diagnostics and genetic screening
  • Class D: This classification includes life-threatening conditions and more specifically transmissible agents in blood and biological materials intended to be transplanted or re-administered into the body. Further, these transmissible agents may also prevent high risks to the wider population. They also specifically cover blood grouping or tissue typing when this involves markers of the following systems: ABO, Rhesus, Kell, Kidd and Duffy.

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Documentation requirements

IVDR requires specific documentation for each device classification.

  • Class A & B: The post-market surveillance report must be updated when necessary and made available to the notified bodies and the competent authorities upon request. Also, single-use IVDS should have a unique device identification carrier on a multi-unit packaging instead of the individual unit packaging
  • Class B, C & D: Economic operators must indicate to the member states, where the device was manufactured.
  • Class C: The periodic safety update report should be made available and accessible to the notified body and the competent authorities upon request. Furthermore, different member states can request the designation of reference laboratories for the verification of the performance claimed by the manufacturer and the compliance with the applicable common specifications. 
  • Class C & D: It is important the manufacturers draw up a  summary of safety and performance as indicated in Art. 29. .1 and this should be uploaded to the EUDAMED database.
  • Class D:  The Periodic safety update report should be submitted electronically to the notified body via EUDAMED where the notified body is required to file its evaluation of the update report. For class D IVDs, the major change is that manufacturers have to continuously involve the reference laboratories. These will verify the performance of the device as claimed by the manufacturers and will continuously do clinical tests.

Bonus read: EU Medical Devices Regulations – Unique Device Identifier (UDI)

Declaration of conformity

For class D devices under the IVDR, manufacturers are required to go through a more conformity assessment process. Under this process, Class D IVDs  will require;

  • A notified body that carries out the conformity assessment issues IVDR certificates to the IVD manufacturers and provides notifications about the information concerning the device and its conformity assessment to EUDAMED;
  • An EU reference laboratory that verifies the medical device performance against the common specifications. The EU reference laboratory will also carry out batch release clinical tests;
  • An expert panel review is an additional procedure for novel devices which did not have common specifications. 

Bonus read: European Medical Device Regulations (MDR) - Regulation (EU) 2017/74

Impact of IVDR on Lab DevelopedTests

  • Lab developed tests are now governed by IVDR to ensure the highest level of protection
  • Health institutions using clinical tests must adhere to Article5(5)
  • The lab-developed tests must meet the general safety and performance requirements (Annex 1)
  • EU member states oversee the lab-developed tests devices manufactured and used in Health Institutions

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Key requirements for health institutions' manufacturing and usage of Lab Developed Test

  • The Health institution must be accredited according to EN ISO 15189 specific national provisions
  • The lab-developed tests must comply with General Safety and Performance Requirement- Annex 1
  • The Health Institution must review the clinical evidence and take corrective actions, if necessary.
  • The Health Institution must compile documentation on lab-developed tests device manufacturing/ design and performance
  • The Health institution will make the declaration of conformity public.

Timeline

  • May 26th 2017: IVDR was first published, 5 year transition period began
  • May 26th 2022: IVDR will be in full effect
    • IVD devices that are already in inventory within EU or EFTA territories can continue to be sold or distributed in a sell-off period.
    • Analysers that are not IVDR compliant, but are sold prior to May 2022, can remain within the market until end-of-life.
  • May 26th 2025: All current IVD devices in the market should be sold off. From this date forward only IVDR compliant devices can be sold or distributed in the market

Conclusion

In conclusion, the regulation that is about to take effect in the EU will bring many advantages for both people and companies. Once the IVDR is active within EUDAMED, it will ensure the quality, safety and reliability of IVD medical devices within the European market. The regulation will increase the transparency of information available publicly. With the new IVDR, printed instructions for use will be part of the IVDR labelling requirements for near-patient tests hence ensuring proper usage of the products. 

Bonus read: New Medical Device labelling requirements in Europe

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