• 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. This regulation was introduced together with a comparable regulation for general medical devices (MDR or Medical Device Regulation). Read more about the IVDR here.

• What is a European Regulation?

Regulations are a form of European law that has a direct effect. Unlike directives, regulations do not first have to be converted into national regulations. Citizens and companies can derive rights directly from it, but at the same time obligations are also directly binding. From (as it now seems) 26 May 2022, the old IVDD (IVD Directive), and the Medical Devices Act based on it, will no longer apply and we are all bound by the IVDR.

• Why is there an IVDR?

In the aftermath of the scandal surrounding leaking PIP breast implants, in which hundreds of thousands of industrial rather than medical silicone gel implants were sold worldwide, there was a call for greater transparency and accountability in manufacturing processes. Within the European Union, this has led to regulations on medical devices and in vitro diagnostics.

• When will the IVDR come into force?

The IVDR will enter into force on 26 May 2022, from then on all manufacturers and users of IVD devices must adhere to the new rules.

• When is a product a "medical device"?

The MDR defines a "medical device" as follows:

any instrument, appliance or device, software, implant, reagent, material or other item intended by the manufacturer for use alone or in combination in humans for any of the following specific medical purposes:

• diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease,
• diagnosis, monitoring, treatment, alleviation or compensation for an injury or disability,
• investigation, replacement or modification of the anatomy or of a physiological or pathological process or a physiological or pathological condition,
• provision of information through in vitro study of specimens derived from the human body, including organ, bleeding tissue donations,

wherein the main intended action in or on the human body is not achieved by pharmacological or immunological means or by metabolism, but can be supported by those means.

• Do these rules apply to all laboratories that provide diagnostics such as clinical chemical or TDM/DoA reagents?

In principle, the IVDR applies to all laboratories that produce IVD medical devices, regardless of whether they are of a clinical chemical or pharmacological nature.

• What will change for our (hospital) laboratory in 2022?

In the first place, the IVDR entails tightening up of validations and performance studies, which have the greatest impact on manufacturers of IVD products. In certain cases, hospital laboratories can also be designated as manufacturers and must also comply with the requirements of the IVDR.

Due to the fact that some manufacturers may not be able to meet the new requirements in time, changes may also occur in the availability of certain medical devices.

In addition, manufacturers may also approach you to collect the (under the IVDR for them) mandatory data on clinical performance of the IVD.

• What does the IVDR mean for reagents produced by our hospital laboratory?

If you have developed a method yourself and also produce your own reagents for this, you will in principle fall under the scope of the IVDR. However, less strict conditions apply to healthcare institutions than to commercial manufacturers, provided a number of conditions are met. This is probably the most important of these conditions for you: no equivalent commercial product should be available on the market. Read more about these conditions here, and the consequences of producing reagents yourself.

• What about diagnostics used in research?

When IVD products are not intended for use as diagnostics in patients, but are only used for research purposes, the requirements of the IVDR do not apply. In practice, however, it happens that such research products are nevertheless used, or are further developed into a product that can be used in practice. At that time, these products fall under the definition of a medical device and they must be developed and produced on the basis of the IVDR.

• What does a validation under IVDR look like?

The IVDR entails a significant increase in requirements for validation (or validation in the wording of the regulation). In short, manufacturers have to provide much more data to ensure that the product is effective and safe. Read more about validation under IVDR here.

• When is a product CE certified under the IVDR?

This depends on the risk classification of the product. Where previously manufacturers were still allowed to self-certify, in most cases this must now be done by a Notified Body. Read more about CE certification under the IVDR here.

• Does an analyzer have to be IVDR compliant?

Analyzers are basically devices that are not specifically made for medical purposes, it is one of several applications. However, when the analyzers have been developed for specific medical purposes and are marketed as such, they are IVD devices within the meaning of the IVDR. Manufacturers who want to keep their analyzers on the market must have them re-certified by a Notified Body.

• Should our lab purchase a new analyzer in 2022?

No, the new regulations do not oblige you to purchase new equipment. In principle, the MDR and IVDR are intended to protect the end user and, by extension, the patient. The tightening of the rules is also primarily intended as additional safeguards for the marketing of medical devices.

It is possible, however, that an existing model no longer complies with the new regulations. If in doubt, contact the manufacturer of your analyzer.

• On how many analyzers must a method be validated on before the IVDR requirements are met?

The IVDR regulation prescribes how manufacturers must demonstrate that their product performs properly both analytically and clinically. There are no requirements for how many analyzers the product or method must be validated. The validation by the manufacturer demonstrates that the product is scientifically based and does what it is supposed to do analytically. It is up to the end user to verify (and if necessary validate) that the product also functions under the prevailing conditions.

• How is diagnotix preparing for the new regulations?

diagnotix has a permanent legal expert who, in addition to quality assurance on the basis of ISO 13485, is fully committed to the upcoming changes.

• How does diagnotix already comply with the new regulations?

As a relatively young company, diagnotix is able to set up as many processes as possible on the basis of the IVDR. diagnotix, for example, is already in contact with a Notified Body to bring all technical files to the requirements of the IVDR. In this way we can guarantee that our entire product line will remain available in 2022.

• Who can provide me with more information about the IVDR?

Information about the IVDR is publicly accessible, anyone can view the text of the regulation via the European Regulatory Database (EUR-Lex). National governments also play a role in the provision of information regarding the consequences for manufacturers and users. In the Netherlands, information is provided through the national government, including information about changes for healthcare institutions.