Along 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. After a 5 year transition period, 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.
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Q1. WHAT IS THE 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.
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Q2. 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. The 5 year transition period to give companies time to comply with the new regulation ends on 25 May 2022.
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Q3. 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 approval by designated Notified Bodies.
- 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’ (PRRC).
- Implementation of unique device identification for better traceability and recall
- Requirements for post market surveillance significantly increased and general timeline for reporting is 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.
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Q4. WHEN DO IVD MEDICAL DEVICE MANUFACTURERS NEED TO COMPLY WITH THE IVDR?
From 26 May 2022 all in-vitro diagnostic medical devices must 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)).
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Q5. 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.
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Q6. 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 significant investment (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 strongly 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.
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Q7. WHAT ARE THE KEY CHANGES AND TIME CRITICAL ELEMENTS TO FOCUS ON?
The Regulation on in-vitro diagnostic medical devices (IVD) has many common aspects and requirements to the Regulation on medical devices but system changes and other IVD specific changes will have important implications and changes for that product sector. These include, but are not limited to:
- Classification system – the IVDR introduces a rules-based classification system for IVDs. IVDs will now be classified into four different classes based on risk from Class A (low) to Class D (high). This will mean that regulation and assessment for each class of device can be tailored accordingly.
- Changes to conformity assessment procedures – IVDs will now be subject to conformity assessment based on the classification of the device. Classes B, C and D IVDs will all require assessment and certification by a Notified Body for medical devices (appropriately designated for IVDs) prior to being placed on the market. This represents a significant change in the system today where many IVDs are self-declared devices rather than being assessed by a Notified Body.
- Performance evaluation and clinical data requirements – the requirements for performance evaluation of IVDs are defined in much greater detail in the new Regulations. Specific requirements are also defined in relation to the use of clinical data for IVDs and the conduct of clinical performance studies.
- Changes to requirements for in-house manufacturing of IVDs – under the existing legislation IVDs which are manufactured within a healthcare institution and for use within that health institution are exempted from the Directive. Such tests may be developed due to the lack of a commercially available alternative e.g. for rare diseases. The new Regulation places requirements on ‘in-house’ IVDs and the healthcare institutions which manufacture them and allows the introduction of additional requirements at national level by individual member states.
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