August 27, 2020 by Maria Nyåkern. Learn more. They are risking patient safety. Classification of IVD under the IVDR. The IVDR will replace the EU’s current Directive on in vitro diagnostic medical devices (98/79/EC). The In Vitro Diagnostic Regulation (IVDR) (EU) 2017/746 is the new EU legislation applicable to in vitro diagnostic (IVD) medical devices. Directive 98/79/EC (referred to in this document as ‘the Directive’). New definition of ‘in vitro diagnostic medical device’ ‘ in vitro diagnostic medical device ’ means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment, or system, whether used alone or in combination, software Under the current IVD Directive,2 IVD reagents found in the two lists in Annex II and IVDs for self- and near-patient testing undergo conformity assessments that require a notified body. Whereas the IVD Directive 98/79/EC specifies Notified Body involvement for only a few high risk IVDs listed in Annex VII, the IVD Regulation introduces risk-based classification Class A to D, based on IMDRFrules and similar to Health Canada and TGA classification rules. The current IVD directive uses a list-based classification scheme that is very limited in application. Under the IVD Directive, devices had been classified according to Annex II, which was divided into two lists A and B which contained defined analytes. Step 6. Complete the performance evaluation. We have to differentiate between several types of “IVD software”: An in vitro diagnostic medical devices, i.e. Classification. It was therefore decided to set up a system of classification rules within the directive, so that each manufacturer could classify its own devices. Specific IVDs are put onto lists to show the level of risk they pose. Step 3. Learn more. Determine classification of your device using the In Vitro Diagnostic Directive : General IVD (Self-certified), Self-Testing IVD*, List B IVD (Annex II), List A IVD (Annex II) Step 2 For the General IVD (Self-certified) class, implement QMS in accordance with Annex III. It also includes the requirements for each device’s technical documentation. No NB involvement. Directive 98/79/EC on in vitro diagnostic medical devices (IVD) (1) cur rently applies to COVID-19 tests. Establish the necessary processes and resources. Decide the intended use and classification of the planned IVD device. Step 2. Risk classification according to IVD Directive or the IVDR; Software safety classification according to IEC 62304; 1. Classification of software as an IVD medical device a) Possible cases. A simple set of classification rules based on technical features of medical devices existing now and in the future is impossible, because of the vast number and the changing nature of variables involved. The possibilities for a rule-based classification system for in vitro diagnostic medical devices (IVDs) were explored in this report as an alternative to the system in Annex II of the European IVD Directive 98/79/EC. Learn more. The IVDR is the new regulatory basis for placing on the market, making available and putting into service in vitro diagnostic medical devices on the European market. The New IVDR Classification necessary changes are compared with the previous In Vitro Diagnostics Directives structure. General Classification System for IVD Medical Devices. Tech Documentation Annexes II and III. Step 5. (1) Directive 98/79/EC of the European Parliament and of the Council (3) constitutes the Union regulatory framework for in vitro diagnostic medical devices. Learn more. Classification In creating the IVDR, the European Commission made major changes with respect to how IVDs are classified in the EU. The manufacturer is IVD Directive Essential Requirements Checklist . Whereas the IVD Directive 98/79/EC specifies Notified Body involvement for only a few high risk IVDs listed in Annex VII, the IVD Regulation introduces risk-based classification Class A to D, based on IMDRFrules and similar to Health Canada and TGA classification rules. Annex IX or Annex XI. The IVDR risk classification system will improve patient safety. The In-Vitro Diagnostic Devices Regulation introduces a new classification system for companion diagnostics and the obligation to undergo a conformity assessment by a notified body. Learn more. In fact, that list in Annex II of the IVDD only takes up half a page, with a short list of what is reviewed by Notified Bodies. IVD Directive Essential Requirements Checklist. What is In Vitro Diagnostic Regulation (IVDR)? If manufacturers don’t conduct a legally compliant performance evaluation of their in vitro diagnostic medical device (IVD), they aren’t just running the risk of problems during the authorization process.. The forthcoming In Vitro Diagnostic (IVD) Device Regulation is approaching the final stages of the review process before becoming law and is the proposed revision to the existing IVD Directive, 98/79/EC. IVD Directive Classification IVD Regulation Classification General Annex II Class A Class B, C, D IVDD 80% No NB interaction IVDR 80% NB interaction Self test. Classification. IVDR drops that approach in favor of a rule-based model. In order to place these tests on the EU market, the manufacturer has to comply with the relevant provisions of the Directive. In the good old days, most the IVD devices could … Compile the technical documentation . MDCG guidance on classification of In Vitro Diagnostic Medical Devices (IVD) MDCG 2020-16: seven classification rules of IVDs for four risk classes . Instead of naming specific IVD devices or medical conditions, the risk classification of a device is determined by its intended The rigid classification system of IVDD now becomes a flexible IVDR Risk Classification system which enables room for new devices and technology developments. •Sterile Class A devices. It is an improvement on the current directive. If the device analyte did not appear in either list, then it was deemed to be low risk and as such the manufacturer could ‘self-certify’ and place the IVD on the market with a Declaration of Conformity. Minimise the risks and fulfil the general safety and performance requirements. A four class system is adopted, the use of an alphabetical system in this document is chosen as a distinctive format. A companion diagnostic is an in-vitro diagnostic test that supports the safe and effective use of a specific medicinal product, by identifying patients that are suitable or unsuitable for treatment.. 2 Scope of the directive 2.1 What is an in vitro diagnostic medical device? The European Union currently operates a list-based system of IVD classification. The … Before the arrangement of IVDD was a basic and inflexible rundown – based framework that took into account diverse choice by various EU states. The document is an important guide for stakeholders in the field of in vitro diagnostics, as the Regulation IVDR (EU) 2017/746 introduces a new classification system based on rules that will subject IVDs to a higher control level. The European Directive 98/79/EC on in vitro diagnostic medical devices, or IVD Directive ... there is a consensus that its classification system is inadequate. 1. Guidance for healthcare professionals covers the use, management and safety of in vitro diagnostic (IVD) devices, including blood glucose meters. The IVDR EU 2017/746 is responsible for governing the regulatory market access for in vitro diagnostic medical devices. The new system of risk classification of IVD medical devices is one of the few radical changes brought about by the new medical device regulations. In-vitro diagnostics (IVDs) are medical devices to be utilized in vitro to examine examples obtained from the human body to retrieve data about a physiological or pathological state, an inborn abnormality, or to determine safety and compatibility with a possible beneficiary, or to screen therapeutic measures. Certain jurisdictions may lower the classification of IVD Medical Devices for which traceability is established through the use of reference measurement procedures and/or available reference materials. Revision of the IVD Directive: IVD specific issues 1. The IVD Regulation is significantly different to the current IVD Directive, including changed classification rules and requirements for conformity assessment. Conformity Assessment Article 48 17 Class A •Annex IV Declaration of Conformity. Classification. Guidance explaining the main features of the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) in relation to in vitro diagnostic medical devices Compared to 98/79/EC IVD Directive (IVDD) the classification of the devices is one of the most important changes which manufacturers must comply during IVDR transition. Tuesday, May 5, 2020. 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 new rule-based risk classification system is more flexible than the list-based system it replaces, allowing the IVDR better to keep pace with technological progress and the need to address emerging medical conditions. In vitro diagnostic medical device manufacturers will soon have to comply with major changes in the European Union’s (EU) long-standing regulatory framework which governs market access to the EU. Entering into force on the 25 May 2017 marking the start of a five-year transition period for manufacturers and economic operators, the IVDR replaces the EU In Vitro Diagnostics Directive (IVDD) 98/79/EC. The IVDR throws those lists out the regulatory window and applies a new risk-based classification system that’s based heavily on a In Vitro Diagnostic Medical Device Performance Evaluation: 8 Steps to Conformity. It should be read in conjunction with vigilance guidance for IVDs and advice for notified bodies on self tests (available on the MHRA’s website). Discover quick facts about the expected changes below. The QMS does not require certification from a Registrar. Step 4.