IVDD to IVDR: Frequently Asked Questions (FAQ)

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Why is there an IVDR?

The in-vitro diagnostics REGULATION (EU) 2017/746 is designed to improve the safety and ensure high quality of CE marked IVD medical device products whilst supporting innovation. Improvements include standardization and harmonized standards, a risk-based classification system, enhanced pre-market oversight, and stringent requirements for scientific validity, analytical and clinical performance as well as in market surveillance. ​

What is the IVDR?

IVDR stands for In Vitro Diagnostics Regulation, this is a European regulation that regulates medical devices in the in-vitro diagnostics category. ​

Healthcare professionals need to be aware that the Regulations are more stringent than the Directives: in general they retain the existing requirements and add new ones. The Regulations emphasize a life-cycle approach to safety, backed up by clinical data.​

During the transition from Directives to Regulations and for a few years afterwards (until 2027), some products certified under the Directives and products certified under the new Regulations will coexist on the market.​

They strengthen the rules for the designation of notified bodies – the independent evaluators of manufacturers and their devices.

In addition, the Regulations introduce a system of unique device identifiers (UDIs) and a new European database for medical devices and in vitro diagnostic medical devices (EUDAMED). This will improve openness by making data available and increasing both the quantity and quality of data, and by enhancing the identification and traceability of medical devices.​

Who is impacted by the IVDR?

The IVDR is in application since 26 May 2022 with a transition period up to May 26 2028.

The IVDR applies to all laboratories that produce IVD medical devices and perform measurements to provide a diagnostic or therapeutic service to persons.

The Regulations introduce new rules for in-house devices, clinical investigations, reprocessing of single-use devices, and distance sales.

Risk classification of devices​

For IVDs, the biggest change concerns the new risk-based classification of in vitro diagnostic devices and the role of Notified Bodies. Each IVD will now be assigned to one of four risk classes (Classes A, B, C or D, the level of risk increasing from A to D) using internationally recognized rules (IVDR Article 47 and Annex VIII). As a result, around 85% of all IVDs will need Notified Body oversight under the IVDR, compared to 20% previously under the IVDD (IVDR Article 48)​

To figure out the classification of your product you can use MDCG 2020-16 as guidance. If in doubt, you should discuss with your Notified Body.

Will all the Non-IVDR kits be withdrawn from the market after May 26, 2022?

IVD kits on the market before May 26, 2022 can benefit from a grace period (depending on the risk classificatio, up to May 2027) if they have a valid Notified Body certificate i.e. Annex II IVDD assays.

After May 26 2022 if an LDT is accredited (ISO15189) can it stay in use if there is CE-IVDR kit covering the same application?

No, an CE-IVDR kit would need to be used unless it can be justified that no kit is suitable for the specific population therefore not deemed equivalent. According to the IVDR, article 5(5d) states: “the health institution justifies in its documentation that the target patient group's specific needs cannot be met, or cannot be met at the appropriate level of performance by an equivalent device available on the market”

Where can I get more information about the IVDR?

A good start is here centralizing multiple information pieces on the Official European Union Website.
National governments also play a role in disseminating the information regarding the consequences for manufacturers and users including information about changes for healthcare institutions.
Access to the European Regulatory Database (EUR-Lex) is open to anyone. ​

Regulations

A "regulation" is a binding legislative act. It must be applied in its entirety across the EU. ​

Directives

A "directive" is a legislative act that sets out a goal that all EU countries must achieve. However, it is up to the individual countries to devise their own laws on how to reach these goals. ​

Would you like to know more on IVDR and Waters IVD solutions? Get in touch with one of our clinical experts