What is it called?
The In Vitro Diagnostic Medical Devices Regulation (IVDR Regulation (EU) 2017/746) governs the making available on the market in the European Economic Area (EEA) and putting into service of in vitro diagnostic medical devices (IVDs) and accessories for such devices. It also governs performance studies taking place in the EEA. The Regulation has been applicable to IVDs, and their manufacturers, importers, distributors and online sales at a distance since 26 May 2022.Read more
What is it about?
The IVDR is primarily designed to ensure that IVDs made available on the EEA market fulfil applicable safety, quality and performance requirements and that IVDs are traceable throughout their supply chain.
Prior to entry into application of the IVDR, IVDs were governed by Directive 98/79/EEC on In Vitro Diagnostic Medical Devices (IVDD). The IVDR introduces a new classification system for IVDs. This system determines the applicable conformity assessment pathway, requirements regarding performance studies and the Technical Documentation that must be prepared for individual IVDs. The IVDR also imposes stricter requirements on performance evaluation and post-market surveillance. Furthermore, the IVDR requires implementation of improved traceability of devices through the supply chain as compared to the related obligations imposed by the IVDD.
The IVDR defines the roles of various economic operators, such as importers and distributors. The Regulation also provides for specific obligations that individual economic operators must fulfill. While the obligations that economic operators must fulfil were previously set down in guidance documents, such as the MEDDEVs, these obligations are now enshrined in the IVDR. Unlike its predecessor, the IVDR, as a Regulation, does not require individual EEA countries to adopt national implementing legislation. The IVDR will, therefore, lead to a more harmonized approach to regulation and marketing of IVDs in the EEA. However, there may still be national requirements introduced in individual EEA countries such as the language to be used on packaging and labels of IVDs marketed in their territory, advertising and promotion, as well as regarding conduct of performance studies.
Who and what does it apply to?
The IVDR is applicable to manufacturers, importers, distributors and online sellers that supply IVDs for the EEA. The scope of application of the IVDR has also been specified to explicitly include companion diagnostics. Moreover, only limited and restrictive exemptions are provided for IVDs manufactured and used within health institutions based in the EEA.
The IVDR includes transitional provisions for those IVDs that have been available on the EEA market prior to the date of application of the Regulation. The possibility to rely on the transitional provisions is, however, subject to strict requirements and conditions. These provisions are not automatically applicable to all IVDs previously marketed in the EEA. An overview of the transitional provisions of the IVDR is available here.
Why does it matter?
Given the extensive and stringent requirements that govern the development, manufacture and marketing of IVDs on the EEA market, it is essential to ensure that an IVD is classified correctly, that all related obligations imposed by the IVDR are fulfilled and documented, and that all economic operators responsible for manufacturing, importing and distributing IVDs in the EEA fulfil their obligations appropriately. Non-compliant devices and economic operators who make these non-compliant IVDs available on the EEA market may face regulatory enforcement actions by the competent authorities of EEA countries.
Under the IVDD, only a small number of IVDs were subject to Notified Body control. As a result of the new classification system and related conformity assessment pathways introduced by the IVDR, approximately 80% of IVDs intended to be made available on the EEA market will now be subject to Notified Body control. For many IVD manufacturers, the involvement of a Notified Body in the conformity assessment of their IVDs will, therefore, be a first experience.
Performance studies may be time consuming and expensive. To save time and costs it is essential to develop a regulatory strategy regarding performance studies that will appropriately generate necessary clinical evidence required to comply with the related requirements imposed by the IVDR. Sponsors of non-compliant performance studies may have their applications for related conformity assessment delayed or rejected.
Furthermore, engaging with economic operators without having a strategy and compliance framework in place may cause delays and confusion both in relation to such interactions and to marketing of IVDs in the EEA. Economic operators marketing IVDs that are not compliant with the requirements of the IVDR may face enforcement actions by the competent authorities of the EEA countries.
Where can I find it?
The IVDR is available here.
Is there any guidance?
The Medical Devices Coordination Group (MDCG) of the European Commission has published a number of related helpful guidance documents available here. These guidance documents are the successors to the MEDDEV guidance, published by the European Commission for the IVDD. The Competent Authorities for Medical Devices (CAMD) has also published helpful guidance, in particular on transitional provisions regarding medical devices that were already placed on the market prior to 26 may 2022. This guidance is available here.