The guidance provides that the intended purpose of an IVD is key to its classification and this should be clearly set out by the manufacturer in the technical documentation and … 2019/10/11. If you cannot find your specific device with your intended purpose clearly defined in the examples, NAMSA can help to determine this. In these roles, Alex managed projects with large multinationals (e.g., Boston Scientific), as well as small start-up companies. . l��.���NO�42��%d�����-���Q�E���ڜ+y�}���'��Xք�=. The new classification will also apply to all IVD devices currently on the market in the EU. Additionally, MEDDEV 2.14/1 (IVD medical devices: Borderline Issues) published in 2012 may still be worth a look for situations not explicitly covered in this new guidance or the IVDR. On 13 November, the Medical Device Coordination Group (MDCG) published their long anticipated IVD Classification guidance document for IVDR (MDCG 2020-16). Economic Operators Alex has been an active member of IVD working group within EU Notified Bodies and TEAM-NB and acting as direct contact for EU competent authorities and EMA on implementation of the EU IVDR (2017/746) and EU MDR (2017/745). In December 2020 the MDCG updated their master list of guidance documents in the works. H��VI�1�ׯ�qF�t�T����W�&z Article 47 requires all IVDs to be classified into one of four classes. The purpose of the document, “is to provide guidance to manufacturers, notified bodies and health institutions on how to classify an IVD prior to placing it on the market, making available on the market or putting into service in the Union. There are some “known unknowns” in the document that may lead to different interpretation by the stakeholders: Supplemental assays are not mentioned (although these are acknowledged in Rule 1, Rule 2 and Rule 3 in Annex VIII of the IVDR), The implication of the difference between the definition of transmissible agent and infective/infectious agents on the classification is not entirely clear, Member states’ (varying) national legislation on blood safety testing could lead to a different classification among member states, or potential off-label use (Rule 1), The document could have borrowed more examples from the existing MEDDEV Medical Device Borderline and Classification document, since these are also applicable to the IVDR. endobj The importance of clearly defining the intended purpose of your IVD is prominently reiterated. ��ќp)�P/�V�Tg5�I��P.̉dup��'�Z�Dڌy������ݟ?/�M��-E�9���jw�[xaekWҙg�@�̕�Qj����X��F��RX'L�}�x��{Ow�A��Bˡ���2(��e��A��L: �4B���$�g,�D�TK�F���2Lk�HqJ�u��P����1��fޛ �JxJ�:θ��r�/��&8����N@�S�.� ���|xF����(A��}�M�~S����^WU�������6t*�,� Our internal teams of medical device and IVD development experts communicate with EU entities nearly every day and are the most experienced in industry at accelerating regulatory submissions and approvals for medical device and IVD manufacturers. This is essentially a repeat of the principle stated in Section 1.7. IVDR In Vitro Diagnostic Regulation BSI The Netherlands (2797) is a leading Notified Body; we review medical devices to ensure that they conform to the requirements of the European Directives and Regulations. The classification of IVDs has changed from a list-based approach in the Directive, to a rule-based approach in the Regulation. The European Commission’s Medical Device Coordination Group (MDCG) on Friday released its much-anticipated guidance on the classification of in vitro diagnostics (IVDs) under the In Vitro Diagnostic Regulation (IVDR). NAMSA is the industry leader in driving successful regulatory outcomes through effective interactions with the EU Commission and Notified Bodies. The European Commission has published a key guidance document on the classification of in vitro diagnostic medical device (IVD) under Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) to give advice to manufacturers, notified bodies, health organizations and other stakeholders on how to classify an IVD. The MDCG has provided explicit examples of many IVD devices and their classifications under IVDR throughout the document. OCT2019 [MDCG 2019-11] – Qualification and classification of medical device and IVD software; In the pipeline… There are many guidance documents being developed by the Medical Device Coordination Group (MDCG). MDCG Guidance on Software Qualification and Classification. Where several classification rules or sub-rules may apply, the intended purpose of the device and its claims, shall be sufficiently specified to enable a clear attribution of the class. <>stream Where this is the case, the most appropriate indent should always be applied, based on the intended purpose of the device (Rule 3). Classification is based on risk, as set out in Annex VIII of the MDR and Annex VII of the IVDR. In order to be acquainted with the state-of-the art in classification of IVDs, this document requires a thorough review by the manufacturer. The majority of the guidance is dedicated to explaining the seven classification rules listed in Annex VIII of the IVDR. Manufacturers can find detailed information about complying with the Federal, Food, Drug and Cosmetic Act (FD&C Act). .. Oh! In short, this guidance document is very helpful in not only understanding the way to classify IVD devices in accordance to the IVDR, but also helping with justifying the right class for the IVD device. %PDF-1.7 The purpose of the document, “is to provide guidance to manufacturers, notified bodies and health institutions on how to classify an IVD prior to placing it on the market, making available on the market or … The guidance provides helpful clarification for manufacturers and, although … It is also intended to inform regulators and other stakeholders when assessing the class attributed to an IVD by a manufacturer or a health institution.” As with all guidance from the MDCG, it is meant to be read in conjunction with the In Vitro Diagnostic Regulation (IVDR). The final version contains some minor additions but no substantive changes from the draft published in May 2007. Figure 1indicates the four risk classes of devices. This guidance provides information on the new EU Regulations for medical devices (MDR) and in vitro diagnostic medical devices (IVDR). Although the guidance states to be not legally binding, in practice, the document will have a big impact on the classification of IVD devices. <> Find the membership plan that suits you, and within a few minutes you are … It may be possible for a device to fall under more than one indent. The MDCG published a very important document for all IVD manufacturers, as well as for notified bodies and health institutions, which shall provide guidance on the classification rules under the IVDR - Regulation (EU) 2017/746, namely its . This document defines the criteria for the qualification of software falling within the … endobj When a device simultaneously detects a marker that falls under two different rules, leading to a different classification, then the highest class prevails for the whole device (Rule 4). BSI UK (0086) is a UK Approved Body able to provide conformity assessments under the new UKCA scheme. MDCG provided seven rules that put IVDs in different risk categories based on how they will be used, as well as principles and other advice to guide companies through the process. Helpful clarification is provided around classifying combination of IVDs with accessories and combination of IVDs with IVD instruments. With experience of classifying medical devices in accordance to the Medical Device Regulation (MDR), it is expected that deviating from the views captured in this MDCG document will certainly raise eyebrows with the EU Competent Authorities and Notified Bodies. The nearly 50-page guidance is intended to explain how IVDs should be classified to manufacturers, notified bodies and healthcare providers before they are … In an effort to capture the essence of the guidance document, the following information will be useful to understand prior to your in depth review and application to your Notified Body. After a brief reminder of applicable definitions and principles of classification, the guidance document explains each IVDR classification rules illustrated by examples. The European Commission's Medical Devices Coordination Group (MDCG) recently published guidance on the qualification and classification of medical device software under the new EU Medical Devices Regulation (MDR) and the EU In Vitro Diagnostic Medical Devices Regulation (IVDR).. %���� It is our simplified overview, based on our extensive experience, and should be used only for guidance. Alex Laan has been in the IVD and Medical Device industry for a total of 20 years with 12 years spent working for a respectable EU Notified Body. 4 0 obj The 28-page guidance also features a decision tree with five steps for the qualification of MDSW and another tree with three decisions for the qualification of MDSW as either a medical device or an IVD. <>stream MDCG 2020-16 Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746 Article 47 of the IVDR EU 2017/746 defines four new risk classes (A, B, C, D) considering the intended purpose of the devices. Visit NAMSA Client Portal for sample submissions, testing reports, project tracking, and more. Your Guide to the IVDR. Accessories are considered devices if they possess one or more specific characteristics to specifically enable an IVD to be used in accordance with its intended purpose or to assist the medical functionality of the IVD (Rule 5). An overview of how the FDA regulates in vitro diagnostic products (IVD). The potential gaps that are highlighted here will hopefully become clear in the coming months in future publications by the European Commission. Summary. Guidance on classification and qualification of IVD software, in line with previously published guidance MDCG 2019-11. As a reminder, the class of the device determines the conformity assessment procedure choice. Last November 2020, the Medical Device Coordination Group (MDCG) published the guideline MDCG 2020-16 “Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746” to explain what are the classification rules of IVDs according to Annex VIII of the IVDR.. MDCG guidance on classification of In Vitro Diagnostic … The use of an alphabetical system in this document is chosen as a distinctive format for GHTF. This flowchart has been prepared by MedTech Europe as a ‘high-level overview’ of the requirements of the Medical Devices Regulation. While classification is primarily the concern of the manufacturer, if the device falls into Classes B, C or D it has implications for the Notified Body. The rule-based approach comprises of four risk categories, from Class A (lowest risk) to Class D (highest risk). Review the guidance and determine if this affects the classification. The European Commission’s Medical Device Coordination Group (MDCG) released a guidance on the classification of in vitro diagnostics (IVDs) under the In Vitro Diagnostic Regulation (IVDR). Mr. Laan also worked for KEMA Quality, beginning in 2006, where he was qualified for Lead Assessor for Medical Devices and IVD devices, Device Specialist reviewer in IVDs and Medical Devices, including drug-device combinations. It looks like you do not have access to this page. 3 0 obj The assessment route depends on the classification of the device. It may be possible for a device to fall under more than one indent. IVD Classification guidance document for IVDR, Website Design, Hosting and Maintenance by MVP Marketing + Design. If a laboratory instrument has an independent measuring function, which does not use any additional reagents, it is classified according to the intended purpose of the analysis (Rule 5). <>/ExtGState<>/Font<>/ProcSet[/PDF/Text]>> The class of any given medical device will be determined using seven rules. © North American Science Associates, Inc. 2021. Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR : EC: Other documents: MDCG 2020-9 Regulatory Requirements for Ventilators and Related Accessories: EC <> endobj The Global Harmonization Task Force’s (GHTF) Study Group 1 has released its final guidance on classification of in vitro diagnostic (IVD) medical devices. Examples for the classification of MDSW under the IVDR include: The IVDR set out four classes (A-D), from lowest- to highest-risk, into which IVDs will be placed. 6 0 obj endstream Overview of requirements under the In Vitro Diagnostic Medical Devices Regulation 2017/746/EU. The MDCG guidance is intended to help IVD companies identify the right risk category for their products. This states: Each of the classification rules shall apply to first line assays, confirmatory assays and supplemental assays. Our guide is simple to understand and will allow you to save time and money when implementing the new regulation. As you are preparing your technical file for submission to your Notified Body for CE Mark under IVDR, the following steps are essential: As with any regulatory guidance, it is important to understand what is stated and that this guidance is not unique in that regard. The new risk-based, flexible classification under the IVDR reduces this risk and is better suited to accommodate changes. Guidance document implant card on the application of Article 18 Regulation (EU) 2017/745 on medical devices: March 2020: MDCG 2019-7: Guidance on article 15 of the medical device regulation (MDR) and in vitro diagnostic device regulation (IVDR) on a ‘person responsible for regulatory compliance’ (PRRC) June 2019: MDCG 2019-3 rev.1 On November 13, 2020, the Medical Device Coordination Group (MDCG) published a Guidance on Classification Rule for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746 with the aim to help manufacturers, Competent Authorities, notified bodies and stakeholders to uniformly apply the classification rules stated in the new regulatory framework. On October 11 th the European Commission released MDCG 2019-11 Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR.This document defines the criteria for the qualification of software falling within the scope of the … Annex XIII, Part A, 1.3.2 of the IVDR spells out the basic requirements for your PER including: Classification of the IVD, taking safety and performance characteristics into account; Intended purpose of your device and performance or safety claims; Technology on … Guidance on Classification Rules for in vitroDiagnostic Medical Devices under Regulation (EU) 2017/746 Page 7 of 44 † Calibrators intended to be used with a device shall be classified in the same class as the device. Your journey may be grouped into 5 Stages: Device Classification. Under IVDR, IVD’s will be divided into four classes: A … Below is a discussion of several key interpretative issues from the risk classification rules of the Regulation. We are very excited about the many FAQ Friday questions we have received in the past months. 1 0 obj MDCG Guidance on IVD Classification Rules Nov 16, 2020 The Medical Device Coordination Group (MDCG), an advisory body of the European Commission focused on the improvement of the regulatory framework for medical devices, has published guidance on classification rules for in vitro diagnostic medical devices (IVDs). 2 0 obj The guide provides industry a clarification on how to accurately classify diagnostics under the IVDR’s risk-based classification system. Section 1.10 of Annex VIII. IVDR Implementation Guide: Below you will find a step-by-step implementation guide with regards to the new in-vitro diagnostic regulation (MDR EU2017/746). The guidance addresses how IVDs should be classified by device manufacturers, notified bodies (NB) and healthcare providers before being placed on the EU market, via the IVDR’s risk-based classification system. The classification determines the conformity assessment route for the device. MDCG guidance provides information on IVDR classification rules The EC released a new Medical Devices Coordination Group (MDCG) document, MDCG 2020-16: Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746. endobj The European Commission’s Medical Device Coordination Group endorsed the related Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR which was made available at DG GROW’s website on 11 October 2019. Proposed General Classification System for IVD Medical Devices A four class system is proposed. Guidance on classification and qualification of IVD software, in line with previously published guidance MDCG 2019-11. Where this is the case, the most appropriate indent should always be applied, based on the. Alex has held the position of Principal Certification Manager at DEKRA Certification BV, a Notified Body for IVDs and Medical Devices located in Arnhem, The Netherlands. [Fp�iѿ�[�UM�(M�T������G-�^���pX-�X΃QR9��dzh�R*�89�Rrb�>�\�X/���x���1�(.��0"܋e�X~G�,,� F���0���Myߧn����7dg��6D �*� ��G�6K{�3�G+��sA`�����GU�S�u�k�|�k�* This page provides an easy-to-follow guide on the implementation of the new In Vitro Diagnostic Regulation (IVDR 2017/746). On 13 November, the Medical Device Coordination Group (MDCG) published their long anticipated IVD Classification guidance document for IVDR (MDCG 2020-16). Manufacturers need to demonstrate that their medical device meets the requirements in the MRD or IVDR by carrying out a conformity assessment. 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