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

3. WHAT ARE THE KEY CHANGES 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 based on intended purpose of the device. 
• 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?

The IVDR DoA is 26 May 2022. After that date, all new (i.e. not previously placed on the market) IVD devices and class A self-declared devices will have to meet the requirements of the IVDR in order to be placed in the European market.

However, an extended transition period is possible for products already on the EU market prior to 26 May 2022.

5. WHAT ARE THE CONDITIONS TO BENEFIT FROM THE EXTENDED TRANSITION PERIOD?

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

6. 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.

7. 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.

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 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.

Request for an IVDR Service Registration today