Key Changes in the Regulatory Requirements for In Vitro Diagnostic Devices Marketed in the European Union Under IVDR 2017/746
Author: Suzanne Broussard
In vitro diagnostic (IVD) medical devices in the European Union are being held to a higher standard of scrutiny with the introduction of In Vitro Diagnostic Regulation (IVDR) 2017/746 by the European Commission (EC).
Overview of In Vitro Diagnostic Regulation 2017/746
The implementation of IVDR dramatically changes the regulatory landscape for IVD medical devices. Some of the biggest changes include an expanded definition of IVDs, a new classification of IVDs, the requirement of Unique Device Identification (UDI) on each device, an expansion of the Quality Management System, and the increased need for Notified Body (NB) review.
The transition into IVDR is already underway. IVDs marketed in the EU will continue to require a CE Marking certificate to verify that the device meets all the regulatory requirements. Failure to meet the IVDR deadlines could be very costly to manufacturers that would either lose their CE Marking or fail to obtain one. The timeline below outlines the deadlines for manufacturers to become compliant with IVDR 2017/746.
IVDR Timeline
The IVDR is being implemented over a 5-year transition period in which it will fully replace the current In Vitro Diagnostic Directive (IVDD) 98/78/EC (Figure 1). IVDR 2017/746 was published May 5th, 2017, in the Official Journal of the European Union, and officially went in to affect May 25th, 2017; that means we are almost halfway through the transition period. During the transitional provisions, manufacturers can meet either IVDD or IVDR requirements. However, starting May 26, 2022, all new IVDs must go through IVDR. Some devices that lawfully obtained IVDD certificates have another 2-year grace period and may continue to be made available until May 27, 2025 (depending on serval factors).
Article 110 Transitional provisions state that “Certificates issued by notified bodies in accordance with Directive 98/79/ED[EC] prior to 25 May 2017 shall become void by 27 May 2024.” IVDs that obtained certificates in accordance with IVDD prior to May 25, 2017 are valid until the end of the period indicated on the certificate, with some exceptions. Certificates issued under Directive 98/79/EC Annex VI become void at the latest May 27, 2024. If a device is lawfully placed on the market under IVDD prior to May 26, 2022 and placed on the market from May 26, 2022 by a certificate (refer to paragraph 2 and 4), the IVD can be on the market or put into service until May 27, 2025.
See IVDR Article 110 and the IVDR Corrigendum number 8 for specific details.
Starting May 26, 2024 IVDR will be full application, and all IVDs must be fully compliant.
Figure 1. IVDR Timeline
It may seem that there is plenty of time to obtain IVDR compliance, but there are many hurdles to obtaining CE Marking under this new regulation. Also consider that there are major changes in almost every aspect regulation for medical devices in the EU, including MDR, MedDev2.7/1 rev.4, and CERs.
Scope of IVDR
The scope of IVDR is massive, and it impacts all aspects of in vitro diagnostic device manufacturing.
The definition of an IVD is expanded to included software and companion diagnostics.
This requires IVDs to use a new device classification system that will place 70%-80% of IVDs in a new category, and, thus, requiring significant work to obtain or maintain market approval.
There is no grandfathering of any device. Even those currently on the market, must conform to the new IVDR standards.
If you are marketing or intend to market any type of In Vitro Diagnostic Medical Device in the European Union, it is time to act. With the need for NBs substantially increasing, it is important to start the process of performing a Gap analysis and finding a NB.
Let’s start by first looking at the newly expanded definition of IVDs under IVDR 2017/746.
If you are marketing or intend to market any type of In Vitro Diagnostic Medical Device in the European Union, it is time to act. With the need for NBs substantially increasing, it is important to start the process of performing a Gap analysis and finding a NB.
Let’s start by first looking at the newly expanded definition of IVDs under IVDR 2017/746.
Definition of In Vitro Diagnostic Devices
Section 1, Article 2 of IVDR 2017/746 expands the definition of IVDs. The addition of software and companion diagnostics to the definition of in vitro diagnostic devices significantly expands the definition of IVDs.Software is a medical device according to the definition of IVD if that is its intended purpose; thus, software as part of an instrument, software as a medical device, and apps are included in the definition of IVDs and fall under IVDR regulation. This includes genetic testing, companion diagnostics, as well as stand-alone software.
The specific definition of In Vitro Diagnostic devices from IVDR 2017/746 is below.
(2) ‘in vitro diagnostic medical device’ means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment, software or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information on one or more of the following:
(a) concerning a physiological or pathological process or state;
(b) concerning congenital physical or mental impairments;
(c) concerning the predisposition to a medical condition or a disease;
(d) to determine the safety and compatibility with potential recipients;
(e) to predict treatment response or reactions;
(f) to define or monitoring therapeutic measures.
Specimen receptacles shall also be deemed to be in vitro diagnostic medical devices;
Section 1, Article 1, 3. Defines what the IVDR does not apply to:
products for general laboratory use or research-use only products, unless such products, in view of their characteristics, are specifically intended by their manufacturer to be used for in vitro diagnostic examinations;
invasive sampling products or products which are directly applied to the human body for the purpose of obtaining a specimen;
internationally certified reference materials;
materials used for external quality assessment schemes.
State of the Art: Building a Solid Foundation for your PER to Support IVDR Readiness
In this webinar, Dr. Sarah Chavez provides an overview of the State of the Art section, and explains how it fits into the overall process of writing a successful, IVDR-compliant Performance Evaluation Report (PER) in a reasonable time frame. A complete readiness assessment and gap analysis will help you identify critical resources, feeder documents, and expertise needed to establish that your IVD may be considered “state-of-the-art.” Ultimately, knowing what the Notified Body expects to see will help you avoid project delays and discover efficiencies in the SOA development process.
Leveraging the MDR experience for IVDR: Tips for Successful Performance Evaluation and PMS/PMPF Processes [Free Webinar]
Have the IVDR Performance Evaluation and Post Market Surveillance requirements got you tied up in knots? Where do you start? What does the end product look like? We are joined by the VP of Regulatory, Quality, and Clinical from Nextern, a collaborative medical device company bringing unmatched core competence in medical device product design and development. Criterion Edge’s President Laurie Mitchell will lead a discussion of their experiences supporting clients through MDR and IVDR requirements.
Effective Corporate Scientific Communication: Strategies to Support your Corporate Narrative and Maximize the Real-World Impact of your Data [Free Webinar]
In this practical presentation, President Laurie Mitchell will: 1) discuss how an effective scientific communication plan is an important marketing tool for an organization, and 2) present five strategies to ensure your corporate objectives are supported and maximize the real-world impact of your data. Join us to learn how this applies to your organization and how to implement these strategies into your current processes.
Hidden Traps That Derail PER Preparedness: Lessons Learned from the MDR-Compliant CER Writing Experience [Free Webinar]
In this practical presentation, Criterion Edge uncovers what we have learned from our experience in writing MDR-compliant CERs, and how urgently applicable some of these key learnings are in preparing a robust Performance Evaluation Report (PER).
Hidden Traps That Can Derail Your CER: Answer These Critical Questions Before You Start Writing [Free Webinar]
As we all know, the MDR has significantly increased both the quality and quantity of inputs needed to complete a CER, needing more up-front planning than the reports have in the past. Based on our experiences with clients both large and small, our President, Laurie Mitchell, shares some of the biggest issues we have discovered when starting an MDR CER project. Laurie also reveals some of the most successful strategies in addressing these issues, up-front and early.
A Practical Guide: Conducting Systematic Literature Reviews in Support of IVDR Readiness [Free Webinar]
In this practical presentation, Criterion Edge breaks down the steps of the SLR process and takes a wholistic approach to conducting an IVDR-compliant SLR. Using case studies, the presentation illustrates the effective use of SLR-derived data to develop the Scientific Validity Report (SVR) and the Clinical Performance Report (CPR).
How to Assess Your CER for MDR Readiness, Part 2 [Free Webinar]
In this second installment of our 2-part webinar series, Criterion Edge shares practical presentation to help you assess your CER through the critical lens of a writer and identify possible gaps for mitigation before prior to submission to regulatory authorities.
Systematic Literature Review: How to Empower Data-Driven Decision Making [Free Webinar]
In this webinar, we share the process of systematic literature review, and discuss the tools and best practices for creating a methodologically-sound systematic literature review.
Experience and Scalability
Watch this video to learn how Criterion Edge is different from the rest.
5 Key Questions to Help Manage Your Budget
This infographic goes through 5 key questions to go through in order to control your budget.
Examining the Implications of the MDR on Data Management
Leading industry experts come together to discuss how the MDR affects data management within their respective units.
MedDev 2.7/1 Guideline: Equivalence and Risk/Benefit Profile
This report clarifies the modifications to the equivalence guidelines in MEDDEV 2.7/1 and Quality Management Systems (QMS) ISO 13485 standard to help develop strategies.
MedDev 2.7/1 Guideline: Qualifications of Evaluators and Scientific Validity
This gap analysis addresses key revisions to evaluator qualifications and scientific validity in the Clinical Evaluation (CE) MEDDEV guideline rev.4.
MedDev 2.7/1 Guideline: More Clinical Evaluations?
The changes to 2.7/1 rev. 4 suggest the need to submit more frequent CERs to regulatory authorities, however, strategies will be discussed for managing the increased requirements.
Data Mining: New Initiatives on Health Care Data that Manufacturers Should be Watching
Every time a healthcare provider makes a notation in the medical chart, a significant and valuable piece of data has been created. This paper discusses the implications of this.
10 Strategies to Build Efficiencies in your Regulatory Writing Process
This piece discusses 10 key strategies to building an efficient regulatory writing process.
State of the Art: Best Practices and Literature Review Using DistillerSR
In this paper, we discuss a prominent clarification on the MEDDEV 2.7.1 rev 4, establishing the “state of the art” section.
Q&A Follow-Up: How to Assess Your CER for MDR Readiness, Part 1 [Free Webinar]
The overwhelming turnout at the ‘How to Assess Your CER for MDR Readiness, Part 1’ prompted us to host a live Q+A session where President Laurie Mitchell exclusively answers all your questions.
Systematic Literature Review To Help Meet MDR Requirements [Free Webinar]
President Laurie Mitchell returns to continue sharing more about the importance of the systematic literature review.
Systematic Literature Review: How to Empower Data-Driven Decision Making [Free Webinar]
In this webinar, we share the process of systematic literature review, and discuss the tools and best practices for creating a methodologically-sound systematic literature review.
State of the Art Literature Review for EU MDR Compliance: How To Get It Right [Free Webinar]
Establishing and defining state of the art for a medical device is no longer an isolated task – it supports the entire Clinical Evaluation Report (CER). Multiple sections of the MEDDEV 2.7/1 rev 4 compliant CER need to be supported by state of the art data, including safety and performance, risk management, and equivalence.
How to Assess Your CER for MDR Readiness, Part 1 [Free Webinar]
In this first installment of a 2-part webinar series, Criterion Edge will present strategies for assessing key components of your CER (or CER template) for possible misalignment with significant and applicable MDR requirements.
Intro to Adverse Event Reviews [Free Webinar]
In this webinar, President Laurie Mitchell discusses why safety reviews are essential in the entire life cycle of product development.
Advantages to Technologies Supporting Endpoint Adjudication [Free Webinar]
Kyoko Hattori from Criterion Edge returns to discuss best practices for managing the adjudication process in-house, and Brian Kelly from AG Mednet will share how the “JUDI” platform can simplify the management of adjudication.
Endpoint Adjudication by the Clinical Endpoints Committee (CEC) [Free Webinar]
In this webinar, learn about CECs, familiarization with regulatory guidance, decision factors leading to use of a CEC, and much more.
Privacy Overview
This website uses cookies so that we can provide you with the best user experience possible. Cookie information is stored in your browser and performs functions such as recognising you when you return to our website and helping our team to understand which sections of the website you find most interesting and useful.
Strictly Necessary Cookie should be enabled at all times so that we can save your preferences for cookie settings.
If you disable this cookie, we will not be able to save your preferences. This means that every time you visit this website you will need to enable or disable cookies again.
3rd Party Cookies
This website uses Google Tag Manager and Pardot's tracking features to collect information such as the number of visitors to the site, and the most popular pages. Keeping this cookie enabled helps us to improve our website.
Please enable Strictly Necessary Cookies first so that we can save your preferences!