Class D; Do’s and Don’ts Process in Class D IVD Medical Device
5 min read

What is a Class D Invitro Diagnostic (IVD) medical Device?

The class D IVD medical device under In Vitro Diagnostic Regulation (IVDR) which encompasses the highest risk in the IVD devices. They are crucial as there are a lot of health implication on the public health, thus having a very stricter regulatory requirements.

The Class D Devices represent the highest risk in the IVD device category which can also include those which are for the detection of the communicable agents which is a danger to the health of the public. It includes assessing safety of blood, tissue and transplantation along with some life-threatening infectious diseases. E.g: Detection of HIV.

Before delving into the Class D Do's and Don'ts process let's delve into the basic definitions to understand better.

  1. Common Specification (CS): Common Specifications are a set of technical and/or clinical requirements, aside from a standard, that provide a means of complying with the legal obligations applicable to a device, process, or system. Within the context of the European Union's regulatory framework for medical devices, Common Specifications are established for certain groups of devices to ensure a high level of protection of health and safety. They serve as a reference for manufacturers to demonstrate conformity with the relevant essential requirements. MDCG has released common specification for class D IVD device (MDCG 2022-3)
  2. European Union Reference Laboratory (EURL): The EURL is a laboratory designated by the European Union to carry out specific tasks related to the verification of in vitro diagnostic medical devices (IVDs). These tasks can include batch verification testing, providing opinions on performance verification by notified bodies, and other specialized testing to ensure that certain high-risk IVDs comply with the EU's regulatory requirements before they are placed on the market.
  3. Batch: In the context of manufacturing and regulatory compliance, a batch refers to a specific quantity of material or product that is intended to have uniform character and quality, within specified limits, and is produced according to a single manufacturing order during the same cycle of manufacture. For regulatory purposes, each batch is usually assigned a unique batch number, which helps in traceability and quality control, ensuring that if there are any issues with a product, the affected batch can be identified and appropriate actions can be taken.

Notified Body procedure for class D

The NB should document the procedure for:

  1. Verification procedures
  2. Establishment of test plan to identify parameters for success and failure of the medical device batches.
  3. Agreement with the manufacturer on testing the samples and location.

Agreement for the batch verification should be placed in accordance with the notified body and the manufacturer for IVDR class D. When an EURL is designated then separate arrangements should be made with EURL for testing.
NBs should draft a plan for testing based on the conformity assessment requirements, EURL performance verification and EURL inputs. The plan should be agreed by both NB and Manufacturers.

Pre agreed conditions include:

  1. Performance of an IVD should be verified by a EURL for that device.
  2. Verification of the batches may be performed by same EURL who performed the testing however in some cases a different EURL can also be assigned who have the required expertise.
  3. In case of multiple EURL to perform batch verification available for a device, the NB decides which EURL is the most appropriate after consulting with manufacturer.

There should be a written contract between the EURL and NB should include:

  1. Testing frequency
  2. Details on samples and specimens to be tested
  3. Test Platform and protocol used.
  4. Critical parameters which are tested
  5. Decision making criteria for success or failure of the batch

NB Provision for Samples for EURLs:

  1. Requirement of Samples: Class D MDV manufacturers in IVDs must make their samples available to NB according to the agreed criteria and conditions.
  2. EURL Testing: The NB must request EURL to carry out batch testing for the IVD Medical Device. Then it informs the NB about their results. The manufacturer can place their class D IVD not later than 30 days after receiving the samples.

Testing Frequency and Sample testing:

  1. First Line Assay: This process is intended to detect the presence of/ exposure to transmissible agents in the blood. Every batch must be tested.
  2. Other Devices: The number of devices to be tested to be determined by the NB which is based on the risk analysis which are verified by the NB. It includes parameters such as no. of batches, previous lots, device design and technology.

Testing Frequency:

Devices which have a considerable amount of data to represent their performance can have reduced number of testing, the NB in collaboration with the EURL can agree to reduce the frequency of testing. The Notified Body procedure includes frequent review the manufacturers risk analysis documents, results of which help the NB and EURL to reduce the testing frequency. Proper justifications have to be documented by the NB in cases where the testing frequencies have been modified. The notified body must take into consideration of the below data

  1. Manufacturers quality system
  2. Batch release date from both manufacturer and EURL
  3. All data related to process change in the product
  4. PMS data
  5. Risk and impact of failure of the device
  6. Availability of common specification
  7. Technical features of product
  8. Stability and shelf life of the product.

Devices for which a failure in control method or product modification is observed the initial testing frequency has to be done again.

Verification of Batches by NB:

The NB is responsible for carrying out verification of batches of Manufactured class D IVD's.

  1. The NB must verify the raw data provided by the manufacturer which are in accordance with the results expected.
  2. In cases of blind testing the NB should verify whether the results provided by manufacturer are in accordance with the results expected.
  3. The NB does decision making for success or failure of a batch.

The NB must document the outcomes of the assessment of the manufacturer data and the findings of EURL The NB must communicate the decision or any conditions to be imposed to manufacturer in a timeframe not less than 30 days after receiving the samples. Once the verification is completed and the manufacturer receives a clear communication to proceed from the NB, the manufacturer can place the device in the market

Challenges and considerations:

  • NB availability: Because of limited number of NB to conduct the assessment under in vitro diagnostic regulation, causing delay in conformity assessment.
  • Implementation Delays: COVID 19 caused delays in designation and EURLs and formation of Expert panels leading to complication of the transition to IVDR compliance.

These contracts ensure clear communication and adherence to testing protocols between the NBs, EURL and the manufacturers.

For optimal handling of Class D IVD medical device, it is crucial for manufacturer and regulatory bodies to ensure necessary process in place before the regulatory guideline.
Adherence to these processes is paramount, ensuring device safety and efficacy and instilling confidence in Regulatory authorities and consumers in the EU market. For more Regulatory support, reach out to us now! Stay informed. Stay compliant.

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