The Road to IVDR Implementation
By Sarah McLeod, M.S., Nerac Analyst
Originally Published March 20, 2023
The “Conformité Européene” (CE) mark is required to distribute and market in vitro diagnostic products in the European Union (EU). Prior to 2017, Conformité Européene designation or CE-marked in vitro diagnostic (IVD) medical devices were governed within the EU by the IVDD or the regional 1998 In Vitro Diagnostic Directive 98/79/EC. (1) Many manufacturers at that time would self-certify product efficacy and affix CE marks to their products and accompanying labels.
Per the BioMed Alliance Diagnostics Task Force, only ten percent of IVD devices, specifically Class C and D devices declared by manufacturers to be able to cause significant harm, required certification by notified bodies. (2-3) The European Commission defines a notified body as an organisation designated by an EU Member State (or by other countries under specific agreements) to assess the conformity of certain products before being placed on the market. (4) When third-party intervention is required, these bodies carry out procedural conformity-related tasks.
In 2017 the directive that had to be placed into effect at the will of EU member countries became mandatory regulation, In Vitro Diagnostic Devices Regulation 2017/746 (IVDR). (5) The IVDR implements higher standards that are designed to improve public health and safety. In accordance it requires more accurate statements of intended use of laboratory diagnostic devices, in-house clinical evidence of analytical performance and published clinical evidence in support of post-market surveillance and follow-up.
Implementation of the IVDR was initially envisaged for all IVD devices on May 26, 2022. The devastating COVID-19 pandemic, however, led to the first change to this projected deadline as many IVD manufacturers began to dedicate research efforts to understanding the SARS-COV-2 virus, developing initial diagnostic PCR and antibody tests, and conducting vaccine development efforts. As a result, in December 2021 the European Parliament amended the IVDR implementation timeline and levied several implementation dates designated by device classification. (6,7)
The IVDR classifies IVD tests into 4 classes based on the risks that a device poses to the public. Class A represents low individual and public health risk. Class B devices pose moderate individual and/or low public health risk. Class C devices may subject users to high individual and/or moderate public health risks. Class D devices pose both high individual and high public health risks. This classification system, while useful for in-depth consumer protection, further delayed IVDR implementation.
To obtain or maintain a CE mark, classes B-D (and sterile class A devices) require notified body certification, thus representing a massive increase of approximately 15% to 90% of CE-IVD tests to be evaluated by a small number of notified bodies. (3,8-9)
The staggered, revised implementation timelines are shown in Figure 1 (cited as Figure 3 in the literature). (10)
Despite the revised implementation timeline, the time to act for IVDR compliance is now.
How Can Nerac Help?
Complying with the new IVDR implementation requirements may seem like a daunting task, particularly for manufacturers who could previously self-certify, but partnering with Nerac can help you navigate the process and successfully achieve compliance. Nerac has a knowledgeable team of analysts/medical writers with expertise in clinical literature searches and targeted literature reviews to support regulatory submissions. The Nerac team assists IVD manufacturers with identifying and analyzing clinical data from the literature as it pertains to state of the art, scientific validity, and device performance, using an approach that has been refined over many years supporting manufacturers with EU medical device submissions.
Contact us here to learn more.
- Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices. Official J Eur Commun. 1998;331:1–37.
- Biomedical Alliance in Europe. Task Force on In Vitro Diagnostics. Available at: https://www.biomedeurope.org/regulatory-affairs/working-group-on-in-vitro-diagnostics.html Accessed March 6, 2023.
- Lubbers BR, Schilhabel A, Cobbaert CM, et al. The new EU regulation on in vitro diagnostic medical devices: implications and preparatory actions for diagnostic laboratories. HemaSphere. 2021;5:e568.
- Notified Bodies [Internet]. Public Health. [cited 2023Mar6]. Available from: https://health.ec.europa.eu/medical-devices-topics-interest/notified-bodies_en Accessed March 6, 2023.
- Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU. Official J Eur Union. 2017;117:176–332.
- European Parliament. European Parliament Legislative Resolution of 15 December 2021 on the Proposal for a Regulation of the European Parliament and of the Council Amending Regulation (EU) 2017/746 As Regards Transitional Provisions for Certain In Vitro Diagnostic Medical Devices and Deferred Application of Requirements for In-house Devices. 2021. Available at: https://www.europarl.europa.eu/doceo/document/TA-9-2021-0498_EN.html Accessed March 6, 2023.
- European Commission. Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL Amending Regulation (EU) 2017/746 As Regards Transitional Provisions for Certain In Vitro Diagnostic Medical Devices and Deferred Application of Requirements for In-house Devices (COM/2021/627 Final). 2021. Available at: https://eur-lex.europa.eu/legal-content/ EN/TXT/?uri=CELEX%3A52021PC0627&qid=1634552565285
- European Commission. Nando (New Approach Notified and Designated Organisations) Information System: Notified Bodies Designated for the IVDR. Available at: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=34 Accessed March 6, 2023.
- van Drongelen A, de Bruijn A, Pennings J, van der Maaden T. The impact of the new European IVD classification rules on the notified body involvement; a study on the IVDs registered in the Netherlands. RIVM Lett Rep. 2018;2018-0082:1–32 Accessed March 6, 2023.
- Dombrink I, Lubbers BR, Simulescu L, Doeswijk R, Tkachenko O, Dequeker E, Fraser AG, van Dongen JJM, Cobbaert C, Brüggemann M, Macintyre E. Critical Implications of IVDR for Innovation in Diagnostics: Input From the BioMed Alliance Diagnostics Task Force. Hemasphere. 2022 May 20;6(6):e724. doi: 10.1097/HS9.0000000000000724. PMID: 35620593; PMCID: PMC9126521.