IVDR Regulations EU: 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 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.

Before placing an in-vitro diagnostics in Europe, a manufacturer must obtain the CE mark by completing the conformity assessment with a notified body. 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 lab-developed tests. Learn everything you need to know about IVDR in the EU.

IVDR Main Objectives

• Promote patient safety,
• Promote free and fair trade among IVD medical device manufacturers, 
• Foster consistent innovation and competitiveness among IVD medical device
  manufacturers,
• Enhance harmony through EU member nations,
• 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.

IVDR 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 multi-unit packaging instead of 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 Article 29. (1). 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)

IVDR 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 provide 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 that do
  not have common specifications. 

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

Impact of IVDR on Lab-Developed Tests

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

IVDR 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.

EU IVDR Key Takeaways

In conclusion, the IVDR regulation that came into effect in the EU has brought many advantages for both people and companies, ensuring 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 labeling requirements for near-patient tests, hence ensuring proper usage of the products. 

We are here to help you stay compliant with the latest IVDR regulations in the European medical device market. Discover the benefits of the EuroDev Sales Outsourcing program, and let's discuss your business opportunities in Europe.

Bonus read: New Medical Device Labels Laws in EU: Your Compliance Guide