FAQs: In Vitro Diagnostic Medical Device Regulation (IVDR)

FAQs: In Vitro Diagnostic Medical Device Regulation (IVDR)

In coincidence with the EU Regulation on medical devices (MDR), the EU Regulation 2017/746 of the European Parliament and of the Council on in vitro diagnostic medical devices (IVDR) entered into force on 26 May 2017. The IVDR will replace the EU’s current Directive on in vitro diagnostic medical devices (98/79/EC).

Discover quick facts about the expected changes below.

1. What is In Vitro Diagnostic Regulation (IVDR)?

The IVDR is the new regulatory basis for placing on the market, making available and putting into service in vitro diagnostic medical devices on the European market. It will replace the EU’s current Directive on in vitro diagnostic medical devices (98/79/EC). As a European regulation, it will be 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.

2. When WAS THE IVDR IMPLEMENTED?

The IVDR came into force on 25 May 2017. Several implementing acts/guidance documents are being issued by the commission and are stipulated to complete some of the requirements to be met.

3. When do medical device manufacturers need to comply to the new IVDR?

From 26 May 2022 new devices will have to meet the requirements of the IVDR in order to be placed in the European market. Products already certified by a Notified Body may be placed on the market until 25 May 2024 under some conditions and if the manufacturer fulfill the specific prerequisite requirements drawn in the IVDR.

4. What are the key changes expected in the new IVDR?

The actual terms of the proposed regulation are subject to change until final publication of the IVDR in the Official Journal of the European Union. Some of the key changes expected include:

• Product scope expansion. Expanded scope will cover diagnostic (including Internet-based) services, genetic testing and other tests that provide information about a patient’s predisposition to a specific disease or susceptibility for a medical treatment.
• Reclassification of devices according to risk. Risk classes will range from Class A for low risk devices to Class D for high risk devices. 
• More rigorous clinical evidence. Manufacturers will need to conduct clinical performance studies and provide evidence of safety and performance according to a device’s assigned risk class.
• Self testing and near patient testing devices will be subject to a premarket approval approach.
• More stringent documentation.
• Identification of ‘person responsible for regulatory compliance’
• Implementation of unique device identification for better traceability and recall
• Requirements for post market surveillance will be reasonably increased and general timeline for reporting reduced.
• More rigorous surveillance by Notified Bodies to reduce risks from unsafe devices
• Greater Scrutiny of Notified Bodies
• No “grandfathering” provisions. All currently approved in vitro diagnostic devices must be recertified in accordance with the new requirements.

5. What are the implications of the new IVDR for In vitro medical device manufacturers?

The complex development process for in vitro diagnostic medical devices, combined with the anticipated changes, are likely to make the transition a complicated and time-consuming process for most device manufacturers. Manufacturers of in vitro diagnostic medical devices are well-advised to stay current on amendments to IVDR by Implementing and Delegated Acts, as well as additional changes that may impact them.

6. What is a significant change under IVDR transitional provisions, article 110?

TÜV SÜD is working on an adopted position regarding the definition of “significant changes” after the date of application of the IVDR. This position will be published on our website and will be sent in parallel for comments to TEAM-NB and NB-MED.

7. What is the status of TUV SUD’s designation for IVDR?

Corrective actions have been provided to authorities and we are waiting for final opinion of the joint assessment team.

8. Where can I get more information about IVDR?

You can also follow the TÜV SÜD LinkedIn showcase page for Healthcare & Medical Devices for the latest information.

6. HOW DO I PREPARE FOR THE IVDR?

In preparing for the IVDR, it is important to inform yourself about the requirements and deadlines of the new IVDR. Additionally, it is important to perform an assessment of how your current product portfolio may be impacted by the new regulations.