Invitro Diagnostic Medical Device Manufacturers and the EU IVDR

IVDR “Date of Application”

The “Date of Application” (DoA) is planned to be on 26 May 2022 and from that point the IVDR will apply fully. For the transition time and allowing a smooth transition several transitional provisions are in place (Article 110). During the transition phase, invitro diagnostic medical devices certified under the Directive and invitro diagnostic medical device certified under the Regulation will coexist on the market. Both will have equal status under the law, and no discrimination in eligibility criteria in public tenders may take place.

What has changes in the IVDR?

The biggest change concerns the In Vitro Diagnostic Medical Devices risk classification of in vitro diagnostic (IVD) devices and the role of Notified Bodies (NBs). The IVDR also clarifies the obligations of economic operators (manufacturers, authorized representatives, importers and distributors).

The IVDD took a list-based approach to assigning risk classes to the invitro diagnostic medical device, which in turn determined the process for assessing conformity and the level of supervision required from NBs. The IVDR instead uses rules recognized at international level to assign each invitro diagnostic medical device to one of the four risk categories (Article 47), ranging from class A (lowest risk) to class D (highest risk). As a result, around 85% of all IVDs will need NBs oversight.

The IVDR also brings tightened requirements for clinical evidence and conformity assessment for the invitro diagnostic medical device. For companion diagnostics, the NBs shall consult the competent authorities for medicinal products (Article 48).

The conformity assessment of class D invitro diagnostic medical device will require the involvement of an EU Reference Laboratory (if designated for that type of device) to verify the performance claimed by the invitro diagnostic medical device manufacturer and compliance with the applicable Common Specifications (article 48.5). In addition, for innovative class D invitro diagnostic medical device where no Common Specifications currently exist, an independent expert panel must provide its views on the performance evaluation report of the manufacturer (Article 48.6). Class D invitro diagnostic medical device produced must be tested by an EU Reference Laboratory (if designated for that type of device).

The good improvement is for the new rule-based risk classification system is more flexible than the list-based system it replaces, allowing the IVDR better to keep pace with technological progress and the need to address emerging invitro diagnostic medical device conditions.

Instead of naming specific invitro diagnostic medical device or medical conditions, the risk classification of a invitro diagnostic medical device is determined by its intended purpose and takes into consideration not only the risk to the individual but also the risk to public health. To classify their invitro diagnostic medical device, the manufacturer should consult the rules listed Annex VIII of the Regulation. If more than one rule applies, the rule resulting in the highest classification should be followed.

The four classes for In Vitro Diagnostic Medical Devices under the IVDR are:

• A: low individual risk and low public health risk (autocertificated)
• B: moderate individual risk and/or low public health risk
• C: high individual risk and/or moderate public health risk
• D: high individual risk and high public health risk.

As same as MDR, IVDR calls for increased transparency, with information on invitro diagnostic medical devices and ‘higher risk’ performance studies being made public. The new European Database for Medical Devices (EUDAMED) will play a central role in providing more complete, accurate and accessible data. The introduction of a unique device identifier (UDI) for every invitro diagnostic medical device will significantly enhance traceability and support post-market safety activities.

The level of clinical evidence needed to demonstrate the conformity of a device becomes progressively more stringent as the risk class increases.

The clinical evidence for each invitro diagnostic medical device is based on clinical data and a Performance Evaluation that demonstrates:

• Scientific validity
• Analytical performance
• Clinical performance.

New to the IVDR is the requirement for post-market performance follow-up to update the performance evaluation when needed throughout the life cycle of the invitro diagnostic medical device.

Invitro diagnostic medical device manufacturer obligations

The invitro diagnostic medical device manufacturer obligations under IVDR are:

• Have the correspondent systems for risk management and quality management;
• Conduct performance evaluations;
• Build up and keep updated the technical documentation;
• Apply a conformity assessment procedure
• Have a designated person responsible for regulatory compliance
• Draw up a declaration of conformity and apply CE marking to their devices
• Manufacturers outside the EU/EEA3 shall have an appropriate contract with an authorized representative based inside the EU/ EEA.

Invitro diagnostic medical device manufacturers are responsible for their devices once they are on the market, by taking appropriate corrective actions, recording and reporting incidents, and by providing appropriate evidence of conformity to authorities.

Also, must have systems in place to cover their financial responsibility for harm caused by defective devices.