EU In Vitro Diagnostic Medical Device Regulation

UNDERSTANDING THE IN VITRO DIAGNOSTIC REGULATION (IVDR)

The IVDR is the current regulatory basis for placing on the market, making available and putting into service in vitro diagnostic medical devices on the European market. It was published in the Official Journal of the EU on 5 May 2017, and entered into force on 26 May 2017, gradually replacing the EU’s former Directive on in vitro diagnostic medical devices (98/79/EC). 

As a European regulation, it is effective in all EU member states and EFTA states immediately without need to be transferred into the law of respective states, however national laws may be adapted to back up some requirements in more detail.

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Key changes 

The IVDR differs in several important ways from the EU’s previous directive on in vitro diagnostic medical devices. The most significant changes in the regulation include:

• Product scope expansion - The scope of IVD devices covered under the regulation is significantly expanded to include among others high-risk devices manufactured for use within a single healthcare institution, as well as diagnostic (including internet based) services, genetic testing and other test that provide information about a patient’s predisposition for a specific disease or for susceptibility for a medical treatment.
• Re-classification of devices - The IVDR employs a classification structure for in vitro devices consistent with that of the Global Harmonization Task Force (GHTF). Risk classes range from Class A for low risk devices to Class D for those devices that pose the greatest risk to patients and the public. The Regulation provides specific rules for properly classifying IVD devices according to their level of risk instead of lists.
• Identification of 'a person responsible for regulatory compliance' - Device manufacturers are required to identify at least one person within their organisation who is ultimately responsible for all aspects of compliance with the requirements of the new Regulation. The organisation must document the specific qualifications of this individual relative to the required tasks.
• Increased Notified Body involvement - The application of the IVDR’s risk classification scheme requires the involvement of a Notified Body for the approval of all but Class A non-sterile devices. As a result, approx. 90 percent of all IVD devices will be subject to Notified Body review, compared with less than 15 percent currently. Concurrently, the requirements for designation and monitoring of Notified Bodies under IVDR are considerably tightened. 
• Implementation of unique device identification - The regulation mandates the use of unique device identification (UDI) mechanisms. This requirement increases the ability of manufacturers to trace specific devices through the supply chain, and to facilitate the prompt and efficient recall of IVD devices that have been found to present a safety risk.
• More stringent requirements regarding technical documentation and clinical evidence - The level of detail regarding the contents of the technical documentation is increasing substantially. The IVDR requires device manufacturers to conduct clinical performance studies and provide evidence of safety and performance proportionate with a device’s assigned risk class. Device manufacturers have to collect and retain post-market performance data as part of the ongoing assessment of potential safety risks. 
• Greater Scrutiny of Notified Bodies – Competent Authorities and Reference Laboratories (if designated) have to be involved in conformity assessment of high risk devices which will result in elongated conformity assessment procedures. Tighter designation rules for Notified Bodies lead to a reduced number of Notified Bodies available. 
• No "grandfathering" provisions – Under the IVDR, all in vitro diagnostic devices already approved had to be recertified in accordance with the new requirements. Manufacturers with previously approved devices had to demonstrate compliance with the IVDR’s new requirements by 26 May 2022, although under specific circumstances an extended transition period is possible for certain devices (see transitional timeline section below for more information on transition deadlines). 

CONFORMITY ASSESSMENT PROCEDURES

The complex development process for most types of medical devices, combined with the need to address new regulatory requirements and obtain Notified Body approval, is likely to make the transition a complicated and time-consuming process for most device manufacturers. Further, previously approved devices are not exempt from the requirements of the new regulation and will need to be re-evaluated and re-approved.

As manufacturers need to apply for an applicable conformity assessment procedure based on their product classification; a step by step information guide on each of the procedures is provided here. 

TRANSITION timeline

Following the publication of Regulation (EU) 2022/112 of the European Parliament and of the Council of 25 January 2022, the transition period depends on the class of the IVD device under the current Directive and future Regulation as well as additional conditions:

• Devices placed on the EU market prior to 26 May 2022 as self-declared (i.e. with no notified body involvement) and that require the involvement of a notified body under the Regulation, may be placed on the market or put into service under the Directive until the following dates:

• 26 May 2025, for class D devices;
• 26 May 2026, for class C devices;
• 26 May 2027, for class B devices and class A devices placed on the market in sterile condition.

• Devices placed on the EU market prior to 26 May 2022 with notified body certificate, may be placed on the market or put into service under the Directive until 25 May 2025

See graph below for a summary of the timeline of Regulation 2022/112 on IVDR Transitional Provisions.

The additional conditions are that no significant changes to the device design and intended purpose are done and the device continues to meet the requirement of the IVD Directive as per IVDR article 110(3).

However, some requirements of the IVDR (e.g. post-market surveillance, vigilance, registration of economical operators, market surveillance) will apply from IVDR DoA as per article 110 (3).

See below for a summary of conditions necessary to benefit from the transitional measures.

How can you prepare?

Although the IVDR Date of Application has passed, implementing and delegated acts as well as guidance documents are still being published. IVD device manufacturers are well-advised to stay current regarding the publication of these acts and guidance documents.

Since most IVD devices will now require Notified Body review and approval, potential delays in the review and approval process by Notified Body should be considered. Therefore, it is recommended that manufacturers consult with their respective Notified Body to evaluate potential issues related to currently approved devices and to develop a plan to address them promptly, and ensure a smooth transition to the IVDR requirements.

How can TÜV SÜD help you?

As one of the world’s largest EU Notified Body for all types of medical devices covered by EU directives and regulations, TÜV SÜD Product Service is designated as a Notified Body under the IVDR. Under the  regulations, stricter requirements are imposed on Notified Bodies and all existing Notified Bodies have to receive new notification. Therefore, it is essential for manufacturers to have a Notified Body who will retain their status under the regulation.

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