On May 25, 2017, the European Directive 98/79/EC was replaced by the European In Vitro Diagnostic Device Regulation (abbreviation: IVDR). Unlike the Medical Device Regulation (MDR for short), which was already implemented as of May 2020, the IVDR is only mandatory after a 5-year transition period.
But this transition period is shorter than it seems. Those who do not immediately take care of the required validations, performance reviews and documentation will soon no longer be able to sell and use their products from the diagnostics sector on the market. The regulation here does not differentiate between new diagnostic products and those already on the market, which means there is no assurance of the status quo and manufacturers must evaluate, verify and, if necessary, certify all products for their risk class.
Quinn Healthcare can provide comprehensive support and guidance during this process.
With the new IVDR, more stringent performance verification requirements apply starting May 26, 2022, particularly with regard to technical documentation and vigilance.
In order to comply with the new IVDR requirements, the performance records of existing products may need to be updated to a significant extent. For this reason, manufacturers should perform so-called GAP analyses for their current products, i.e. complete and systematic actual/target comparisons, in order to identify gaps in the performance record of their products.
In the IVDR a new classification system applies to In-vitro-Diagnostic devices. Instead of the previous lists, the IVDR now defines in seven rules in Annex VIII the four risk classes A, B, C and D. In the future, products of class B or higher will require the involvement of a Notified Body. This change inevitably leads to an enormous increase in the number of products that must be monitored by a Notified Body.
Class A: Includes non-critical, low risk products such as wash solutions, buffers or general culture media.
Class B: Includes less critical parameters, such as glucose or leukocytes. Class B is also the “Default class” for parameters that do not fall under any of the above rules.
Class C: Includes products with critical values, such as all genetic tests, almost all companion diagnostics (CDx), tests to determine disease stages or infectious diseases, prenatal tests or tests for newborn screening. Most self-testing (by patients) also falls into this class.
Class D: Includes products with highly critical values, such as for transfusion medicine or for determining life-critical and at the same time highly infectious diseases.
The regulation is to be implemented directly in the member states and should thus lead to a harmonization of the standards of in vitro diagnostic medical devices within the EU. Thus, the classification of the products determines the way of conformity assessment.
Following the product classification, different procedures for assessment result for each product category. In addition to the four risk classes, the IVDR distinguishes other types of in vitro diagnostic devices. These are products for near patient testing (NPT), products for self-testing (by patients / lay persons), and companion diagnostics.
The selection of possible conformity assessment procedures has essentially been reduced to three options as a result of the new directive:
For Class A devices without sterility requirements, conformity assessment is based solely on the Technical Documentation (TD, Annex II IVDR) and the TD on post-market surveillance (Annex III IVDR).
All other devices may be placed on the market under an additional full quality assurance system plus Technical Documentation assessment (Annex IX IVDR) or type examination plus production quality assurance (Annexes X and XI IVDR). The IVDR differentiates in the assessment of technical documentation whether this must be done per product category (class B), per product group (class C) or per product (class D).
Conformity assessment of class D devices further requires the involvement of European reference laboratories, whose task is to verify the performance of the product and compliance with relevant specifications (Common Specifications, CS).
Technical documentation (TD, English “”Technical File””) refers to all the documents that manufacturers of medical devices and IvDs must provide. For manufacturers of in vitro diagnostic devices, it is mandatory to describe exactly what the product is intended to do within its intended purpose. They must make clear how they will ensure that these services are actually provided and that there are no unacceptable risks. The performance data are, for example, about analytical services or diagnostic services (sensitivity/specificity). The requirements for performance evaluation have also become correspondingly extensive. This technical documentation is the prerequisite for the conformity assessment and thus for the approval of IvDs.
The introduction of a new product identification number (UDI) brings new labeling requirements, that go far beyond what is required today. Through the use of UDI labels, the EU is aiming for holistic transparency of the product. The goal is to trace medical devices quickly and easily. This allows for a quick response in case of problems, as products are on the one hand easier to identify (per device, batch or software version) and on the other hand traceable, search localization of devices and users can be found faster and more accurately. In addition, illegally distributed medical devices can be identified more easily.
If manufacturers wish to place a product on the market in the EU according to IVD (except class A products), a notified body must be involved in the approval or conformity assessment process.
Depending on the conformity assessment procedure chosen for the product, the task of the notified body is, among other things
check the technical documentation and/or
to test each individual product batch (class C, D) and
perform a type examination and/or
audit, certify or monitor a quality management system
Ultimately, however, the responsibility for product compliance with regulatory requirements remains with the manufacturer. Quinn Healthcare can assist you in both finding and communicating with Notified Bodies.
Do you have questions about one of our services, or would you like to explain your project in a personal meeting? Then feel free to contact us directly here.
Support in the complete performance evaluation of your product in the field of In-vitro-Diagnostics according to the new IVDR regulations.
Full support in regulatory processes and review of European directives and regulations for In-vitro-Diagnostics and Medical Devices
Supply Chain & Distribution Management
Offer of broad services in the area of logistics, warehousing and distribution of your products
Consulting and implementation of individually designed sales and marketing strategies, as well as the establishment of a European distributor network or own distribution