In-vitro Diagnostics Regulation correctly applied: These requirements result for your CE-compliant product

In-vitro Diagnostics Regulation correctly applied: These requirements result for your CE-compliant product

Before 2022, three directives regulated medical devices in the EEA: the Active Implantable Medical Devices Directive (AIMDD - 90/383/EEC), the (General) Medical Devices Directive (MDD - 93/42/EEC) and the In Vitro Diagnostics Directive (IVDMDD - 98/79/EC).

The new EU Regulation on in vitro diagnostics (IVDR), Regulation (EU) 2017/746, replaced Directive 98/79/EC. It modernises the legal framework for medical devices and sets stricter requirements. Manufacturers had a transitional period until May 2022 to adjust their documentation and processes.

According to the Regulation (2017/746), in vitro diagnostics (IVDs) are medical devices that examine human body samples outside the body. They provide information on health conditions, genetic aspects, treatment effects and monitoring of therapies. Examples include HIV test kits, blood glucose meters and special sample containers for diagnostic purposes outside the body. General laboratory products are not covered by this category.

IVDR - Regulation on in vitro diagnostics (EU) 2017/746

Frequently asked questions

Q&A

Which EU directives applied to medical devices before 2022?

Medical devices were regulated by three directives in the EEA (European Economic Area) until May 2022.

  • Directive on active implantable medical devices, AIMDD (90/383/EEC)
  • (General) Medical Device Directive, MDD (93/42/EEC)
  • Directive on in vitro diagnostics, IVDMDD (98/79/EC)
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What is the new EU regulation on in vitro diagnostics and its transitional period?

Two new regulations now replace the above-mentioned directives on medical devices in order to

  • to create a modernised and more robust EU legal framework,
  • at the cutting edge of science and technology,
  • provide better protection of public health and patient safety

The new Regulation (EU) 2017/746 (hereinafter referred to as IVDR) on in vitro diagnostics replaces Directive 98/79/EC. Manufacturers have a transitional period of five years until May 2022 to update their technical documentation and processes to meet the new, more stringent requirements.

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What are in vitro medical devices (IVDs)?

The new regulation (2017/746) defines an in vitro diagnostic agent (IVD) as: "medical device used as a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, software or system - individually or in conjunction with each other - by the manufacturer for in vitro testing of samples originating from the human body, including blood and tissue donations, is intended and is intended solely or primarily to provide information on one or more of the following

  1. about physiological or pathological processes or states,
  2. about congenital physical or mental impairment,
  3. on the predisposition to a particular health condition or disease,
  4. to determine the safety and tolerability of potential recipients,
  5. about the expected effect of treatment or the likely reactions to it
  6. for the determination or monitoring of therapeutic measures

Examples of IVDs are:

  • HIV test kits
  • Antigen tests
  • Immunoassay analyzers
  • Blood gas analyzers
  • Calibrators and control materials used to check the performance of the analyzers
  • Sample tubes and blood collection tubes
  • Blood glucose meters and strips

Products for general laboratory use are not considered IVD, but products specifically designed for in vitro diagnostic testing are considered in vitro diagnostics.

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What is the category of medical in vitro diagnostics (IVD) under the old directive?

In the IVD Directive (98/79/EC), IVDs are hierarchically divided into the following four categories according to perceived risk:

  • General/other IVDs: Products other than those covered by Annex II to the Directive and products for own use
  • IVDs for self-testing: Products that may be used by laypersons in the home environment, except for the self-testing equipment referred to in Annex II
  • IVDs according to Annex II List B: Reagents and products for rubella, toxoplasmosis and phenylketonuria as well as devices for self-monitoring of blood glucose
  • IVDs according to Annex II List A: Reagents and products for human immunodeficiency virus I and II and hepatitis B, C and D

IVD Directive 98/79/EC (IVDD) requires the inclusion of BS/CA only for a few high-risk IVD listed in Annex VII. easyCE can help you classify your product.

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What is the new classification for IVDs under IVDR?

In a slight deviation from the IVDD, the IVDR introduces a risk-based classification of classes A to D, where D represents the highest and A the lowest risk category. This new classification means that for most IVDs, a notified body or a competent authority must be included in the CE conformity assessment process (as opposed to the manufacturer’s self-declaration under the IVDD).

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What applies to IVD class D products according to IVDR?

The following risk conditions generally apply to Class D products:

  • general life-threatening conditions
  • transmissible agents in blood and biological materials intended for transplantation or reprocessing into the body (transmissible agents may present a high risk)
  • Blood grouping or tissue typing, if they are markers of the following systems: ABO, Rhesus, Kell, Kidd and Duffy
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What applies to IVD class C products according to IVDR?

Class C includes the following risk conditions:

  • high-risk IVD products that pose a lower risk to the general public
  • if the failure of a diagnosis could be life-threatening (including tests for infectious diseases and cancer)
  • accompanying diagnostics and genetic screening
  • own application in general with certain exceptions.
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What applies to IVD class B products according to IVDR?

Class B covers all IVD products that are not specifically covered in other classification rules. These usually include the following products:

  • Products with lower risk to the patient and the population than IVD Class D and C products
  • self-medication for pregnancy and fertility tests as well as for the determination of cholesterol levels and for the detection of glucose, erythrocytes, leukocytes and bacteria in the urine
  • Controls without a quantitative or qualitative value.
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What applies to IVD class A products according to IVDR?

Class A comprises laboratory equipment, instruments and sample vessels in the broadest sense. Only Class A devices are approved for self-certification for conformity assessment with the CE marking.

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What does the new classification of IVD products mean?

Seven rules describe risk-based IVDR classes that take into account the intended purpose of the products and their inherent risks. In classification, the emphasis is on demonstrating the performance of the product. Although most IVD medical devices must be certified under the new classification rules by notified bodies (BS or NB) (an estimated 80% of manufacturers are classified into higher risk classes according to IVDR)this is essential for improving patient safety. Nevertheless, the manufacturers of these products will be heavily affected by the complex requirements and the control by the notified bodies.

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What are the challenges of the new IVDR?

Important aspects of Regulation (EU) 2017/746 on in vitro diagnostics (IVDR) that are challenging for manufacturers:

  • classification rules
  • technical documentation
  • general safety and performance requirements
  • unique product marking (UDI)
  • EUDAMED
  • performance evaluation
  • monitoring after placing on the market

How can easyCE help me? The easyCE expert network supports you in the creation or conversion of necessary documents on all points listed above, for example. easyCE also advises you on the necessary information on the product, the packaging and the package insert.

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What innovations does the IVDR bring with regard to technical documentation?

The requirements and the expected quality of the technical documentation have increased. The documents are subject to a closer examination by the competent authority (NL). The clinical data must be solid enough to properly substantiate all claims. Manufacturers must improve the scientific quality and comprehensibility of their technical documentation.

The technical documentation for IVD shall include information on the design, intended use, risk assessment and path to conformity in accordance with general safety and performance requirements and the quality management system (QMS). The post-market performance assessment and monitoring report shall be kept and updated in the technical documentation in addition to the design history record and.

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How do I archive the technical documentation?

Technical documentation should be kept secure and protected from unauthorized access and alteration. Under IVDR legislation, manufacturers are required to keep the technical documentation for CAs/NBs for a period of at least 10 years after the last product is placed on the market.

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What innovations does the IVDR bring regarding the general safety and performance principles (SPR)?

The extended version of the Basic Requirements is now referred to as the General Safety and Performance Principles or Requirements (SPR). The SPR/GSPR under the IVDR cover many aspects to be considered and are listed in Annex 1 to the Directive. easyCE can support you in the preparation of the necessary documentation.

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What is the UDI system?

The introduction of an UDI system aims to improve the traceability of all medical devices on the market by placing a unique code on the label of the product. UDI is primarily used for reporting serious incidents and identifying counterfeit medical devices. According to the IVDR regulation, every manufacturer is obliged to introduce a UDI system. The basic UDI-DI must be included in the technical documentation, the declaration of conformity and the certificate of the notified body. Basic UDI-DI and UDI-DI are used for registration in EUDAMED.

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What is EUDAMED?

As part of the IVDR/MDR, EUDAMED serves as a central database for the registration of economic operators and products, but also for vigilance reports and performance studies. EUDAMED will improve the transparency and coordination of information on medical devices available on the EU market to meet vigilance reporting and analysis requirements, including serious incidents On-site safety corrective actions and trend reports.

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What innovations does the IVDR bring with regard to performance evaluation?

A major challenge of the IVDR is the updated and specified requirements for performance evaluation. It defines a continuous process to provide sufficient clinical evidence to demonstrate that the intended clinical benefit is achieved and the product is safe.

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What innovations does the IVDR bring with regard to post-market monitoring?

PMS and in this context Post-Market Performance Follow-Up (PMPF) play an important role within the IVDR. Post-market data must be used to update essential documents, such as risk management and performance evaluation. Manufacturers are required to prepare the relevant documents in accordance with the IVDR, for example the PMS Plan and Report/ Periodic Safety Update Report (PSUR).

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How is the CE marking procedure described under the IVDR?

The CE marking procedure for in vitro diagnostics covers two aspects: general compliance and the actual conformity assessment procedure. easyCE accompanies you through the entire procedure outlined below:

  1. Appointment of a European representative
  2. Classification of the device and identification of all EU directives/regulations applicable to your product (such as IVDR, WEEE, EMC, etc.)
  3. Selection and implementation of the product-specific conformity assessment procedure
  4. Verification of the equipment against general safety and performance requirements (Annex I)
  5. Identification of applicable harmonised standards
  6. Preparation of a technical dossier (Annex II and III) and implementation of a quality management system, preferably based on ISO 13485
  7. Selection of a notified body (except for Class A)
  8. Audit of the QMS and technical documentation/design dossier by a notified body
  9. CE marking and ISO 13485 certificates issued by the notified body
  10. Preparation of a legally binding declaration of conformity (DoC) by the manufacturer
  11. Affix the CE marking
  12. Registration of IVD with the competent European authority (Ministry of Health), in the country of the authorised representative
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How does the conformity assessment procedure for IVD differ from other medical devices?

The CE conformity assessment procedure for IVD is similar to that for medical devices, but there are some significant differences due to the different risks associated with the different products. This results in different conformity paths for different risk-based classes. The table below explains the compliance pathways for different categories of IVD products.

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How do I get an ISO 13485 certification?

For products other than "A", the QMS and technical documentation must be audited by a European notified body. The CE marking certificate of the device and the ISO 13485 certificate of the production site are issued after successful completion of the 3-party audit. The ISO 13485 certification must be renewed every year, CE marking certificates are usually valid for 3 years.

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How are the harmonised IVDR standards developing?

On 15 May 2020, the European Commission published its Implementing Decision M/565 on the development of harmonised standards under the Medical Devices Regulation (MDR) and the In Vitro Diagnostics Regulation (IVDR). Implementing Decision M/565 reflects significant changes in the development of harmonised standards for IVD products:

  • The changes are technology-neutral and performance-related.
  • Most standards refer to processes and not products and are harmonized.
  • The number of harmonised standards is decreasing, there are only 41 for IVDs.
  • Standards should address several specific aspects, e.g.:
    • EN ISO 10993-7:2008: The method for calculating the maximum residue limits should also take into account the body weight of well below 70 kg
    • EN ISO 10993-17:2009: Biological assessment of medical devices - Part 17: Determination of permissible limit values for excreted substances Body weights below 3.5 kg (newborns) must be taken into account
    • ISO 23908: Protection against injuries caused by sharp/pointed instruments - Requirements and test methods - Features for protection against sharp/pointed instruments for subcutaneous needles, insertion tools for catheters and needles for blood collection: MDR/IVDR Annex I, Sections 11.1 (Reduction of the risk of infection for patients and users) and 22.2 (products for lay use) must be taken into account in the harmonised version of ISO 23908.
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What are the tasks of the responsible person/expert?

Article 15 of the IVDR clearly states that manufacturers of medical devices are obliged to have within their organisation or at their disposal at least one person who has the necessary expertise in the field of medical devices. The responsible person must ensure that the technical documentation is prepared and maintained.

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What are the tasks of the authorised representative?

In accordance with Article 11 "the manufacturer of a product not established in a Member State shall designate a single authorised representative". The authorised representative shall, inter alia, provide a copy of the technical documentation, thereby ensuring effective communication with the notified bodies in relation to the manufacturer’s obligations.

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What are Notified Bodies for?

Notified bodies (BS) or Notified Bodies (NB) are responsible for ensuring the safety and conformity of all in vitro medical devices placed on the EU market.

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