On May 26, 2017, the EU Regulation 2017/746 of the European Parliament and the Council on in vitro diagnostic medical devices (IVDR) became active under the EU Regulation on Medical Devices (MDR). Recertification by May 26, 2022, became required for all previously approved products. The IVDR will replace the EU’s current Directive on in vitro diagnostic medical devices (98/79/EC). Products that are not already approved (carry the CE Mark) must be registered certified following the new requirements starting May 26, 2022. The new rule reclassified some products and established four categories based on importance to patients’ health and/or risk. In addition, they created a schedule for products that are already certified to be re-certified/updated per the new regulation as follows:

All devices will need to be divided into classes, A, B, C, or D, taking into account their purpose intended by the manufacturer and inherent risks​.

• Class A – low to moderate risk (General Controls)​
• Class B – moderate to high risk (Special Controls)​
• Class C – high-risk (Pre-market Approval)​
• Class D- Transmissible Disease, Blood screening, High risk disease, High-risk Blood groups​ (Pre-Market Approval)

The new In Vitro Diagnostic Medical Devices Regulation can be found here. Discover FAQs regarding the expected changes below.

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 being transferred into respective states’ law; however, national laws may be adapted to back up some requirements in more detail.

When was the IVDR implemented?

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

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

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

What are the fundamental changes expected in the new IVDR?

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

• Product scope expansion. The 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 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 usability 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 pre-market approval approach.
• More stringent documentation.
• Identification of ‘person responsible for regulatory compliance.’
• Implementation of unique device identification for better traceability and recall
• Post-market surveillance requirements will be reasonably increased and the 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 re-certified in accordance with the new requirements.

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, is likely to make the transition complicated and time-consuming 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. Further. it is recommended that manufacturers of products already on the market perform a gap assessment of current product, technical and clinical information against the new requirements to properly plan and execute those activities to update existing information or obtain new information where required.

Where can I get more information about the IVDR?

The European Commission itself: https://europa.eu/european-union/index_en

Notified Bodies, as of January 27, 2022​, the following are recognized by the EU Commission:

•   NB 2797 BSI Group The Netherlands B.V. Netherlands​
•   NB 0344 DEKRA Certification B.V. Netherlands​
•   NB 0124 DEKRA Certification GmbH Germany​
•   NB 0459 GMED SAS France​
•   NB 0197 TÜV Rheinland LGA Products GmbH Germany​
•   NB 0123 TÜV SÜD Product Service GmbH Germany​

How do I prepare for the IVDR?

In preparing for the IVDR, it is vital to inform yourself about the requirements and deadlines of the new IVDR. Additionally, it is crucial to assess how the new regulations may impact your current product portfolio.

Premier Consulting has experienced experts who can help answer your compliance-related questions and advance your diagnostic medical device program toward approval. Contact us to learn more about our experience.

Authors:

Matthew Nowland
Vice President, Regulatory Affairs

Charles Chrisawn
Senior Program Director – WHDx, Premier Research