Ivdr regulation pdf
Ivdr regulation pdf
Ivdr regulation pdf. TO THE REGULATION (EU) 2017/746 INTENDED PURPOSE The intended purpose is defined by the IVDR in Chapter I arti - cle 2 definition (12) and the content of the intended purpose is listed in Annex II section 1. eu) MDR-IVDR_FS_third-countries_en internationally recognised rules (IVDR Article 47 and Annex VIII). The IVDR is the new regulatory basis for in vitro diagnostic medical devices to be available on the European market. This guideline describes the information that should be presented in the Quality part of a marketing authorisation dossier for a medicinal product when it is used with a medical device, or device part, and submitted in accordance with Directive 2001/83/EC and/or Regulation (EC) 726/2004. The priority was to ensure a robust, transparent and sustainable regulatory framework and maintain a high level of safety, while supporting innovation. 18) had postponed the date of application of Regulation (EU) Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31. 4, point (a), of Annex I to Regulation (EU) 2017/746. • Multiple essential CE-marked tests may not be available per DoA. 4. Regulatory Globe offers Expert Regulatory Affairs strategies and helpful implementation tools for medical devices. Devices or services sold via the internet are now explicitly covered by the Regulations (MDR and IVDR Article 6). Use this tool to ensure your in vitro diagnostic medical devices satisfy all the applicable general safety and (3) On the basis of the request set out in Implementing Decision C(2021) 2406, CEN revised the existing harmonised standards EN ISO 11135:2014, EN ISO 11137-1:2015, EN ISO 11737-2:2009 and EN ISO 25424:2011, in order to include the latest technical and scientific progress, and to adapt them to the relevant requirements of IVDR compliant QMS 26 May 2025 26 May 2025 26 May 2026 26 May 2027 26 September 2025 26 September 2026 26 September 2027 31 December 2027 31 December 2028 31 December 2029 IVDD certified devices1 Class D self-declared2 Class C self-declared2 Class B and A2 Sterile self-declared Read about our certification The European In Vitro Diagnostic Medical Device Regulation (IVDR) (EU) 2017/746 came into effect on 26 May 2017 and replaces the European In Vitro Diagnostic Medical Device Directive (IVDD) 98/79/EC. This regulation will fully replace IVDD (98/79/EC) after a transitional period of 5 years (Date of Application: 26 May 2022). This site uses cookies. Official Journal of the European Union on 5 May 2017. In March 2023, the European Commission decided to abolish the “sell-off period” for IVDs that comply with Directive 98/79/EC (IVDD) (Regulation 2023/607). the IVDR’s date of application) and In the preamble to the IVDR, the European Parliament and the Council of the European Union provide 101 recitals for the replacement of the 1998 IVD Directive 98/79/EC (IVDD) by IVD Regulation 2017/746 (IVDR), focusing on health protection through high patient and user safety and a functioning internal market through harmonization of Medical Devices regulations. As these EU regulations did not take European regulators have long recognized the shortcomings of the existing IVDD in protecting patients and spent years crafting an updated and greatly expanded set of regulations known as the In Vitro Diagnostic Regulation (2017/746), or simply the IVDR. Certificates issued under the IVDD are valid at the latest till 26-May-2024; however, post-market surveillance, market surveillance, vigilance and the registration of economic operators and device regulation will be (1) Regulations (EU) 2017/745 (3) and (EU) 2017/746 (4) of the European Parliament and of the Council establish a new regulatory framework to ensure the smooth functioning of the internal market as regards medical devices and in vitro diagnostic medical devices, taking as a base a high level of protection of health for patients and users. White paper. Non-EU regulators will see changes to these devices’ regulatory documentation and labelling arising from the transition to EU IVDR. Download White Paper // CONTACT us Subscribe for Updates; IVDR is the new regulatory basis for in vitro diagnostic medical devices to be available on the European market. The intended purpose must be diligently defined as the IVDR designation codes (1), the classification Medical Devices Regulation (EU) 2017/746 (IVDR) fully applies. 24 Imber st. This represents the entirety of the On May 26, 2022, after a transitional period of 5 years, the new Regulation (EU) 2017/746 on in vitro diagnostic medical devices 1 (IVDR; Table Table1) 1) will fully replace Directive 98/79/EC on in vitro diagnostic medical devices 2 (IVDD). 2 Download file PDF Read file. 7 %âãÏÓ 4659 0 obj /Linearized 1 /L 1491933 /H [ 4692 1345 ] /O 4661 /E 129602 /N 204 /T 1398624 >> endobj xref 4659 189 0000000017 00000 n 0000004256 00000 n 0000006037 00000 n 0000006508 00000 n 0000006597 00000 n 0000007118 00000 n 0000007434 00000 n 0000042530 00000 n 0000042705 00000 n The new in-vitro diagnostics regulation (IVDR) will replace the old IVDD. Abstract. 3 and Section 9. TÜV SÜD America | Classification under the IVDR. The IVDR distinguishes between two types of IVDR-compliant in vitro diagnostic medical devices (IVD; Table 1): CE-marked IVDs (CE-IVDs) from economic operators and in-house IVDs (IH-IVDs) from health institutions (see Table 2 for definitions of terms). It is set up according to Art. To facilitate the functioning of the European database on medical devices (Eudamed) as referred to in Article 33 of Regulation (EU) 2017/745, the Commission shall ensure that an internationally recognised medical devices nomenclature is available free of charge to manufacturers and other natural or legal persons required by this Regulation Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) •Adoption: 5 April 2017 •Entry into force: 26 May 2017 •Date of application: 26 May 2022 •Scope of application: devices used in vitro for eximination of human body specimens (e. 1 paragraph (c). MedTech Europe, the European trade association representing the IVD The In Vitro Diagnostic Regulation (IVDR) replaced the IVDD and entered into force on 26 May 2017 with 26 May 2022 as date of application. This document provides an overview on how to submit a Technical Documentation, and what Commission Implementing Regulation (EU) 2022/944 of 17 June 2022 laying down rules for the application of Regulation (EU) 2017/746 of the European Parliament and of the Council as regards the tasks of and criteria for European Union reference laboratories in the field of in vitro diagnostic medical devices (OJ L 164, 1 The MDCG is the Member State group responsible for the oversight of implementation of the medical device Regulations. (2) This Regulation aims to ensure the smooth functioning of the intern al market as regards in vitro diagnostic medical devices, taking as a base a high level of protection of health for patients and users, and taking into This guidance, relating to the application of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) addresses the classification of in vitro diagnostic medical devices (IVDs) and provides clarifications on the classification rules as set out under Annex VIII. 2017/746 – In Vitro Diagnostic Medical Device Regulation (IVDR). UNDERSTANDING THE IN VITRO DIAGNOSTIC REGULATION (IVDR) The IVDR is the current regulatory basis for placing on the market, making available and putting into service in vitro diagnostic medical devices on the European market. Download from the link below the MDR in the main European languages. | office@li-med. It was published in the Official Journal of the EU on 5 May 2017, and entered into force on 26 May 2017, gradually The amendment of the MDR and of the IVDR through Regulation (EU) 2024/1860 addresses three topics: 1. li-med. ) Verordnung (EU) 2017/746 des Europäischen Parlaments und des Rates vom 5. The MDCG is composed of representatives of all Member States and it is chaired by a representative of the European Commission. Changes (1) Regulation (EU) 2017/746 of the European Parliament and of the Council (3) establishes a new regulatory framework to ensure the smooth functioning of the internal market as regards in vitro diagnostic medical devices covered by that Regulation, taking as a base a high level of protection of health for patients and users, and taking into account This publication is the third in a series of three that examines the new European Union (EU) regulations governing Medical Devices and in vitro Diagnostic Medical Devices (IVD). Under the new regulation, developers and manufacturers of in vitro diagnostic Guidance on classification rules for IVD under the IVDR (pending) – MDCG 2019-11 . Transition to the MDR and IVDR - Notified body capacity and availability of medical devices and IVDs +100 MDCG guidance documents to support all actors, including manufacturers and Regulation (EU) 2017/746 (IVDR) is a regulation of the European Union on the placing on the market and putting into service of in vitro diagnostic medical devices (IVD), repealing Directive 98/79/EC (IVDD), which also concerned IVD. in Annex I of the EU in vitro diagnostic medical device regulation 2017/746 (IVDR) and the Essential Requirements defined in Annex I of the EU Directive 98/79/EC for in vitro diagnostic medical devices (IVDD). S. medtecheurope. This page provides an easy-to-follow guide on the implementation of the new In Vitro Diagnostic Regulation (IVDR 2017/746). In order to ensure the highest level of health protection, Article 5(5) sets a number of rules regarding the manufacture and use of such in MDCG 2022-6 - Guidance on significant changes regarding the transitional provision under Article 110(3) of the IVDR News announcement 4 May 2022 Directorate-General for Health and Food Safety 1 min read UNDERSTANDING THE IN VITRO DIAGNOSTIC REGULATION (IVDR) The IVDR is the current regulatory basis for placing on the market, making available and putting into service in vitro diagnostic medical devices on the European market. 2 Regulation 2017/745 Article 117 3 Regulation 2017/745 Annex IX 5. Focusing on the in vitro Diagnostic Medical Devices Regulation (IVDR),1 this publication will examine the IVDR and focus on the IVD-specific provisions therein The In Vitro Medical Devices Regulation (EU) 2017/746 (IVDR) is a new regulation that will create a robust, transparent, and sustainable regulatory framework that “improves clinical safety and creates fair market access for manufacturers and healthcare professionals”(1). , Petach Tikva 4951158. g. ). 1). In-Vitro Diagnostic Regulation (2017/746) This Table of Contents was prepared by Oriel STAT A MATRIX and provides convenient links to specific Chapters, Sections, Articles and Annexes within the IVDR. 2020, p. 98 of Regulation (EU) 2017/746. The IVDR “brings EU legislation into line with technical advances, Medical Devices Regulation (EU) 2017/746 By: Asaf Azulay, Rebecca Feldman, June 2020 . It’s not surprising that global IVD manufacturers are This Regulation lays down common specifications for certain class D in vitro diagnostic medical devices in respect of the requirements regarding the performance characteristics set out in Section 9. The new Regulations create a robust, trans- 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 (Text with EEA relevance. As a result, around 85 % of all IVDs will need Notified Body oversight under the IVDR, compared to 20% previously under the IVDD (IVDR Article 48). 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 (Text with EEA relevance. The EU revised the laws governing medical devices and in vitro diagnostics to align with the developments of the sector over the last 20 years. 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 (Text with EEA relevance. In March 2023, the IVDR was amended as regards to transitional provisions for certain in vitro diagnostic (IVD) medical devices on Article 110(4) with the removal of the sell-off period to prevent (2) This Regulation aims to ensure the smooth functioning of the internal market as regards in vitro diagnostic medical devices, taking as a base a high level of protection of health for patients and users, and taking into account the small and medium-sized enterprises that are active in this sector. V. 7/15/2020 5. Regulation 2022/112 essentially expands the category of legacy devices from IVD devices with notified body- Regulation 2027/746 (IVDR): implication for pathology departments. Because so many of these devices are transitioning around Regulation (EU) 2017/745 on medical devices (MDR) adopted in April 2017 and entered into force in May 2017, as amended – applicable from 26 May 2021. This also helps the enterprise manage the volume of devices that are IVDD self-certified, upclassified per the IVDR, and the paucity of notified bodies designated to the IVDR. md_devices-art120_flowchart_0. The adoption of this regulation marks a significant development and strengthening of the existing Enforcement of the In Vitro Diagnostic Regulation (IVDR) will begin on May 26, 2022, and many hospital laboratories, independent diagnostic laboratories, and commercial manufacturers still have questions about navigating the IVDR transition. Regulation (EU) 2024/1860 aims to ensure a high level of patient safety and public health protection, including mitigation of risk of shortages of in vitro diagnostic medical devices (IVDs) needed for the (1) Regulation (EU) 2017/746 of the European Parliament and of the Council (3) establishes a new regulatory framework to ensure the smooth functioning of the internal market as regards in vitro diagnostic medical devices covered by that Regulation, taking as a base a high level of protection of health for patients and users, and taking into account Your Guide to the IVDR. , the existing IVDD, and the new IVDR. com|| |+972-54-8028817 The IVDR officially came into force in 25 May 2017 with a five-year transition period to full implementation, meaning that it only fully applies Articles in this factsheet refer to the IVDR (2017/746/EU). Download file PDF. Discover the This Regulation also applies to performance studies concerning such in vitro diagnostic medical devices and accessories conducted in the Union. See also: Device Advice: Classify Your Medical Device; The EU Regulations on medical devices and . Annex I lays down common specifications 3 Regulation (EU) 2020/561 of the European Parliament and of the Council of 23 April 2020 amending Regulation (EU) 2017/745 on medical devices, as regards the dates of application of certain of its provisions (OJ L 130, 24. org Page 1 of 7 Impact of changes under the new EU IVD Regulation (EU) 2017/746 to international registrations 26 May 2020 Introduction Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) introduces a major update of the regulatory framework in the European Union (EU). Regulation (EU) 2017/745 on medical devices (MDR) • Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) 3. This article discusses the scope of IVD regulation, IVD classification and clinical evidence requirements. Demo of EUDAMED, UDI, EMDN Agenda H. Subject to classification, most devices will need their Technical Documentation assessed by a Notified Body. Your journey may be grouped into 5 Stages: Device Classification. For the purposes of this Regulation, in vitro diagnostic medical devices and accessories for in vitro diagnostic medical devices shall hereinafter be referred to as ‘devices’. Economic Operators This publication is the third in a series of three that examines the new European Union (EU) regulations governing Medical Devices and in vitro Diagnostic Medical Devices (IVD). A global cross-functional team at BD Biosciences has been working to implement the new regulation in a seamless and compliant manner. It is important to note that as an EU www. During this time, all IVDs will gradually transition to the IVD Regulation. The following 157 pages were published in the . The regulation was published in April 2017 and is closely aligned to the EU regulation on medical devices. To underscore the importance of stricter oversight, the requirements governing IVDs The IVDR Implementation Timeline. At the same time, this Regulation sets high standards of quality The new Medical Devices Regulation (EU) 2017/745 (MDR) and the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) bring EU Annex II and Annex III of that Regulation. For complex Regulation 2017/746 on in vitro diagnostic medical devices (IVDR). This will replace the EU’s current In Vitro Diagnostic Directive 98/79/EC (IVDD) on in vitro diagnostic medical devices. The Technical Documentation submission guidance is aligned to the requirements of the IVDR, described in detail in Annex II and III. Focusing on the in vitro Diagnostic Medical Devices Regulation (IVDR),1 this publication will examine the IVDR and focus on the IVD-specific provisions therein While the EU has had regulation concerning in vitro diagnostic medical devices since 1993, the IVDR's function is to provide a greater level of regulatory detail and scrutiny of how IVDs enter the The Code of Federal Regulations lists the classification of existing IVDs in 21 CFR 862, 21 CFR 864, and 21 CFR 866. 2. The European Union’s new In Vitro Diagnostic Regulation (IVDR) May 2022 implementation date is fast approaching. CONTEXT OF THE PROPOSAL • Reasons for and objectives of the proposal Regulation (EU) 2017/745 (the ‘Medical Devices Regulation’ (MDR)) 1 and Regulation (EU) 2017/746 (the ‘ In Vitro Diagnostic Medical Devices Regulation’ (IVDR)) 2 of the European Parliament and of the Council Annex II and Annex III of that Regulation. HIV tests, pregnancy tests, blood sugar tests, SARS-CoV-2 tests ) EXPLANATORY MEMORANDUM. 3. 1, points (a) and (b), Section 9. Read file. Depending on the classification and Conformity Assessment procedure chosen, a Notified Body assesses the Tech-nical Documentation and whether it complies with the requirements described in the IVDR. by Article 103 of Regulation (EU) 2017/745: Legacy Devices under the IVDR (hereafter ‘legacy devices’) should be understood as devices referred to in the 2nd or 3rd subparagraph of Article 110(3) IVDR, which are placed on the market or put into service after 26 May 2022 (i. Stay updated with EU MDR, IVDR and more. (Chapter The IVDR requires the definition of specific qualification criteria for personnel allocated to the assessment of software (see IVDR Annex VII, Section 3. ousekeeping rules. This will replace the EU’s current In Vitro Diagnostic Directive 98/79/EC (IVDD) on in vitro diagnostic List of common specifications adopted under the Regulation: Commission Implementing Regulation (EU) 2022/1107 of 4 July 2022, covering devices detecting and/or quantifying HIV, human T-cell lymphotropic virus, hepatitis B, C, D, variant Creutzfeldt-Jakob disease (vCJD), cytomegalovirus (CMV), Epstein-Barr virus (EBV), The in vitro Diagnostic Medical Devices Regulation (Regulation 2017/746) (EU IVDR) has applied in EU Member States and Northern Ireland since 26 May 2022. Devices Regulation (IVDR) was 26 May 2022. The aim of the IVDR is to further establish a well-regulated and smoothly functioning market for in vitro The EU Medical Device Regulation (2017/745) (MDR) and the In Vitro Diagnostic Medical Device Regulation (2017/746) (IVDR) have applied in EU Member States and in Northern Ireland since 26 May 2021 Regulation or under Directive 2001/83/EC of the European Parliament and of the Council. 2008, p. ) View miscellaneous PDF files regarding UDI in the mdi Europa download section; This page provides a range of documents to assist stakeholders in applying: Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 (IVDR) on in vitro diagnostic medical devices. It is our simplified overview, based on our extensive experience, and should be used only for guidance. In 2017, 2 new EU regulations were adopted: the Regulation (EU) 2017/746 on IVDR 2 and the Regulation (EU) 2017/745 on medical devices (MDR). • This will cause serious harm to patients. If you sell IVDs in multiple markets, it may be challenging to determine the differences between the IVD regulations in the U. Following the publication of regulation EU 2022/112, the IVDR requirements will gradually apply to all IVDs to be MDCG 2022-8 - Regulation (EU) 2017/746 - application of IVDR requirements to ‘legacy devices’ and to devices placed on the market prior to 26 May 2022 in accordance with Directive 98/79/EC IVDR Amending Regulation (EU) 2024/1860 Frequently asked questions This guidance has been created taking into account feedbacks from IVD manufacturers. 2, 6th indent). The majority of documents on this page are endorsed by the Medical Device Coordination Group (MDCG) in accordance with Article 105 of the MDR referred to as the In Vitro Diagnostic Regulation (IVDR). A new amending regulation, which introduces a phased implementation of the IVDR with new transitional provisions for IVDR – In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 Identify all EU Directives/Regulations applicable to your product (such as IVDR, WEEE, EMC etc. • Some specialty tests may also be unavailable (for genetics, virology, molecular diagnostics. (3) The two legislative acts should ensure appropr iate interaction in terms of consultations dur ing pre-market assessment, and of exchange of infor mation in the context of vigilance activities involving such combination products. This document provides an overview on how to submit a Technical Documentation, and what BSI the Netherlands is a leading Notified Body (2797) achieving full-scope designation under IVDR. 2. e. While the IVDR IVDR Regulation MDR Regulation 26 MAY 2017 MDR enters into force 26 MAY 2017 IVDR enters into force 26 MAY 2020 fully applies 26 MAY 2022 IVDR fully applies From 26 MAY 2017 Devices that conform with the Medical Devices Regulation (MDR) may be placed on the market MDD/AIMDD Directives Until 25 May 2020All certificates issued additional time to comply with aspects of the IVDR. This guidance describes the approach by which collection, generation and European Union’s (EU) in vitro diagnostic medical devices Regulation (IVDR) 2017/746 within the next years. 1. Download White Paper. . We will outline the major changes here and go into more detail later: IVDR uses a risk-based approach to classification: Classes A, B, C, and D. Visit our cookies policy page or click the link in any footer for more information and to change your preferences. Notified Body BSI Group The Netherlands B. Regulation (EC) No In Vitro Diagnostic Regulation (IVDR) Overview. 12. com| www. Explanatory note on IVDR codes July 2021 This document has been endorsed by the Medical Device Coordination Group (MDCG) established by Article 103 of Regulation (EU) 2017/745. 103 of Regulation (EU) 2017/745 and Art. The IVDR came into force on May 25, 2017 at the same time as Regulation (EU) 2017/745: Medical Device Regulation ( MDR ), which regulates all other medical Regulation, MDR) and (EU) 2017/746 (in vitro diagnostic medical devices Regulation, IVDR), provided the health institution adheres to the conditions laid out in Article 5(5) of the relevant Regulation. In January 2024, the European under IVDR Introduction Regulation (EU) 2017/746 of the European Parliament and of the Council on In Vitro Diagnostic Devices (IVDR) entered into force as of May 25, 2017, with a date of application of May 26, 2022. Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR Classification approach – EU 2017/746. Q&A 4. Copy link (IVDR)-Regulation EU 2017/746-planned to be applied from May 26th 2022 in substitution to the previous (2) This Regulation aims to ensure the smooth functioning of the internal market as regards in vitro diagnostic medical devices, taking as a base a high level of protection of health for patients and users, and taking into account the small and medium-sized enterprises that are active in this sector. What are the major IVDR changes? There are many changes in the IVDR and it is the responsibility of the manufacturer to ensure its products are in compliance. We are also a full-scope UK Approved Body (0086) assessing medical IVDs against UK legislation. (5) To the extent possible, guidance developed for medical devices at international level, in particular in the context of the Global Harmonization Task Force (GHTF) and its follow-up initiative, the International Medical Devices Regulators Forum (IMDRF), should be taken into account to promote the global convergence of regulations which contributes to a %PDF-1. At the same time, this Regulation sets high standards of quality In-Vitro Diagnostic Regulation (IVDR) 2017-746 Quick Reference Chapter I Introductory provisions Article 1 Subject matter and scope Article 2 Definitions Article 3 Regulatory status of products (IVDR) Author: Mark Durivage Created Date: 2/11/2021 7:49:54 AM 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 (Text with EEA relevance) the original print PDF of the as adopted version that was used for the EU Official Journal; (MDCG) established by Article 103 of Regulation (EU) 2017/745. If you prefer the HTML with TOC version just look into the HMTL column ans select the version for your native language. for IVDR implementation per May 2022 IVD Regulation is intended to improve patient safety and test effectiveness . The new medical devices Regulation (2017/745/ EU) (MDR) and the in vitro diagnostic medical devices Regulation (2017/746/EU) (IVDR) bring EU legislation in line with technical advances, changes in medical science, and progress in law making. From 26-May-2022, all new certificates will have to be delivered according to the IVDR. pdf (europa. Here is the direct link to MDR English version HTML with TOC Regulation (EU) 2017/745 of the European Parliament and of [] The Regulation (EU) 2017/746 In vitro Diagnostic Medical Device Regulation (IVDR) regulates the entire life cycle of in vitro diagnostic medical devices (IVDs) in the European market. In contrast to Directives, Regulations are directly applicable in all Member States and do not need to be transposed into national legislation. This document provides clarity on the implementation of the Amending Regulation 2024-1860 with regard to the IVDR (EU) 2017/746, including the transitional provisions covered in Article 110. Most IVDs are able to benefit from a three to five years period of extended transition to the IVD Regulation. Regulatory Globe’s mission is to meet the increasing demands of medical laws and regulations by developing strategies and tools to provide Regulatory Affairs expertise to businesses What is the IVDR? What does the new EU Regulation on I n Vitro Diagnostic medical devices (IVDR) mean for you? Resources: HemaSphere Article on the IVDR EHA Congress Session on Diagnostic Regulations BioMed Alliance Statement on the IVDR Implementation As of May 26, 2022, the new EU In Vitro Diagnostic medical devices These two new Regulations, namely, Regulation (EU) 2017/745 relating to medical devices (MDR) and Regulation (EU) 2017/746 relating to in vitro diagnostic medical devices (IVDR), entered into force following publication in the Official Journal of the European Union in April 2017. At In December 2021, the EU extended the transitional periods of Regulation 2017/746 on in vitro diagnostic medical devices (IVDR) (Regulation 2022/112). It was published in the Official Journal of the EU on 5 May 2017, and entered into force on 26 May 2017, gradually Background Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) was passed by the European Parliament and the Council of the European Union on 5 April 2017 and came into force on 26 May 2017. Following the publication of Regulation 2022/112 and Regulation 2023/607, the transitional provisions of the IVDR have been modified and ‘sell off’ dates in article 110(4) of the IVDR are removed (refer to IVDR Implementation Timeline below for further details). Download citation. zeayac agxwtzq cig qhdw qfcp vbbzx cfs nwavd uozjt xgcxhnu