What is the IVDR?

The IVDR is part of an overhaul of the regulatory framework for medical and in vitro medical devices in the EU, along with Regulation (EU) 2017/745 relating to medical devices (“MDR”), which entered into force last year. The IVDR seeks to enhance public safety and modernise public health by imposing higher quality and safety standards for in vitro diagnostic medical devices (“IVDs”).

The IVDR replaces the In Vitro Diagnostic Medical Devices Directive 98/79/EC (“IVDD”). As the IVDR is a Regulation, it applies directly in all EU Member States. This should allow for a more consistent regulatory approach and greater legal certainty across the EU than under the previous regime. The provisions of the IVDR are implemented into Irish law by the In Vitro Diagnostic Medical Devices Regulations 2022 (S.I. No. 256/2022).

Transitional timelines

• An IVD issued with a certificate of conformity issued by a notified body under the IVDD before 26 May 2022 may continue to be placed on the EU market until its certificate of conformity expires or 26 May 2025 at the latest.
• For IVD products which previously did not require notified body approval and which had acquired IVDD declarations of conformity prior to 26 May 2022, the applicable IVDR transitional period depends on the class of the IVD in question:
• Class D – 26 May 2025;
• Class C – 26 May 2026;
• Class B and relevant Class A devices – 26 May 2027.

Where an IVD is on the EU market during the transitional period under an IVDD certificate of conformity, the product must continue to comply with the IVDD and the product cannot be significantly altered, for example in relation to its design or intended purpose, or it may lose the benefit of using its IVDD conformity to access the EU market. However, the requirements of the IVDR in respect of post-market surveillance, market surveillance, vigilance, registration of economic operators and registration of IVDs will apply and replace the requirements in that IVDD.

Classification of IVDs under IVDR

As of 26 May 2022, an IVD must comply with the IVDR if it is to be placed on the EU market. What is required in order to comply with the IVDR depends on the classification of the product. The IVDR creates a classification system whereby IVDs are divided into categories based on patient and public health risks, ranging from Class A (low risk) to Class D (high risk):

• Class A: IVDs that present a low risk to patients and public health such as specimen receptacles, laboratory instruments, and buffer solutions.
• Class B: IVDs that are intended for self-testing which pose a lesser risk to the patient than those in Class C. It includes products such as pregnancy tests and cholesterol tests. Class B is also the catchall category for IVDs which do not fall into another class.
• Class C: IVDs that are intended to be used to detect an infectious agent without a high risk of propagation, or to detect the presence of an infectious agent with the potential to cause death or severe disability in the case of an erroneous result.
• Class D: IVDs that detect or are exposed to life-threatening transmissible agents or transmissible agents and infectious diseases with a high risk of propagation. This includes antigen tests.

The IVDR contains seven rules which determine the classification of an IVD. Where an IVD falls into Class A, generally it can be marketed in the EU with just the self-certification of its manufacturer. However, it is anticipated that the vast majority of IVDs will fall into Class B, C, or D. Where a device falls into any of these three classes, it must undergo an independent audit of its compliance with safety and performance requirements, carried out by a notified body.

Obligations under IVDR

The IVDR sets out a wide range of obligations for both manufacturers and regulatory authorities for post-market surveillance of IVDs. For example, manufacturers must have quality management systems and monitoring procedures in place which are proportionate to a product’s risk class and intended use. Furthermore, manufacturers must establish a system for risk management, incident reporting, and for tracking corrective safety actions. Manufacturers must demonstrate that their device safely performs its intended purposes using clinical data and performance evaluation results. More specifically, they must compile a performance evaluation report for each IVD demonstrating the scientific validity, analytical performance, and clinical performance of the product.

Notified Bodies

The IVDR sets out stricter requirements for organisations seeking to be notified bodies for the purposes of the IVDR. Notified bodies are designated by their national ‘Designating Authority’ – in Ireland this is the Health Products Regulatory Authority (“HPRA”).

In order to be designated as a notified body, an organisation must undergo both a national designation assessment and an independent assessment carried out by independent experts from EU authorities.  Once an organisation is designated as a notified body for the purpose of the IVDR, it will still be subject to oversight from the national regulatory authority of the Member State in which it is established (in Ireland, the HPRA) in order to ensure its ongoing compliance with the obligations of the IVDR and that it retains the necessary competence to carry out its activities. This oversight primarily consists of audits of a notified body’s premises and observed audits of the notified body’s quality system assessments.

For further information, please contact Colin Kavanagh or Bridget Clinton.