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FAQs: In Vitro Diagnostic Medical Device Regulation (IVDR)

Be confident of medical device market approval

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 EU commission and are stipulated to complete some of the requirements to be met.

3. WHAT ARE THE KEY CHANGES EXPECTED IN THE IVDR? 

Some of the key changes of the IVDR include:

  • Product scope expansion. Expanded scope covers 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 range from Class A for low risk devices to Class D for high risk devices. 
  • Premarket approval required. All device classes except nonsterile class A are subject to Notified Bodies approval
  • Class C/B excluding Self-test, near patient test and Companion Diagnostics, are subject to assessment of Technical Documentation on a sampling basis. All other devices are assessed individually. For class A sterile, the Notified Body assessment is limited to the assessment of sterility.
  • More rigorous clinical evidence. Manufacturers need to conduct clinical performance studies and provide evidence of safety and performance according to a device’s assigned risk class.
  • Identification of ‘person responsible for regulatory compliance’
  • Implementation of unique device identification for better traceability and recall
  • Requirements for post market surveillance significantly increased and general timeline for reporting reduced.
  • Greater Scrutiny of Notified Bodies
  • No “grandfathering” provisions. All currently approved in vitro diagnostic devices must be recertified in accordance with the new requirements.

4. WHEN DO IVD MEDICAL DEVICE MANUFACTURERS NEED TO COMPLY TO THE IVDR?

From 26 May 2022 all 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 fulfils the specific prerequisite requirements drawn in the IVDR (Article 110 (3)).

5. What is the meaning of placing on the market?

Placing on the market implies that the device is manufactured and sold by the Manufacturer or Importer to a different legal entity although not necessarily physically transferred. Any subsequent operation, for example, from a distributor to an end-user is defined as making available. Both placing on the market and making available on the market refer to each individual device, not to a type of device, and whether it was manufactured as an individual unit or in series.

Consequently, even though a device model or type has been supplied before the IVDR Date of Application, individual units of the same model or type, which are placed on the market after the Date of Application, must comply with the IVDR requirements.

6. WHAT ARE THE IMPLICATIONS OF THE IVDR FOR IN VITRO MEDICAL DEVICE MANUFACTURERS?

The IVDR introduced many changes to the regulatory requirements for IVDs in the EU as explained in question 4 above.

These changes will require strong investments (time, resources, budget) from Manufacturers to meet the new requirements.  In addition, guidance documents, Implementing and delegated acts are still to be published. Manufacturers of in vitro diagnostic medical devices are well-advised to stay current on amendments to IVDR and work with their Notified Body to ensure a timely review and approval of their devices ahead of the IVDR Date of Application.

7. WHAT IS A SIGNIFICANT CHANGE UNDER IVDR TRANSITIONAL PROVISIONS, ARTICLE 110?

TÜV SÜD is working with other Notified Bodies on a common position regarding the definition of “significant changes” after the date of application of the IVDR and how they should be managed. This position will be published on our and TEAM-NB websites.

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.

Additional resources are available on TÜV SÜD website at in vitro diagnostic medical device regulation resources.

Guidance documents published by the Medical Device Coordination Group (MDCG) are available on the EU Commission Website.

9. 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 IVDR. Additionally, it is important to perform an assessment of how your current product portfolio may be impacted by the IVDR.

10. How TÜV SÜD can assist you?

Independently from the IVDR certification process, TÜV SÜD can assist with testing (e.g. physical testing, cybersecurity) of your IVD device. For more information, please visit the following webpage.

If you would like to request TÜV SÜD services for IVDR certification, please consult our IVDR Service registration page.

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