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All IVDR Services With 40 years of experience as a provider of testing services for the safety and quality of in vitro diagnostic medical devices (IVD), we are a competent partner for transitioning to the IVDR In addition, we support manufacturers of IVD and medical devices with market access services into the European and international marketsPrinted course presentation, a printed spiral bound book of the IVDR Regulation (EU) 17/746, a short test and a certificate is included for all participants Course Leader/s Emma Axelsson, Senior Quality and Regulatory Consultant AnnaKarin Areskog, Senior Quality and Regulatory ConsultantThe IVDR was put in force by the European Union on May 25, 17 as a replacement for the existing In Vitro Diagnostics Directive (IVDD) The EU has mandated a fiveyear transition period, so IVD manufacturers will have until May 26, 22 to comply with all the new requirements However, the IVDR is regarded as unprecedented in both the number

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The IVDR uses a riskbased classification system with classes ranging from A (the lowest risk) to D (the highest risk) Under IVDR requirements, a Notified Body must inspect Class ASterile as well as Classes B, C, and D productsAbout IVDR The InVitro Diagnostic Medical Devices Regulation (IVDR) will replace the existing InVitro Diagnostic Medical Devices Directive (IVDD) The IVDR was published in May 17, marking the start of a fiveyear period of transition from the IVDD For further information, please visit EURLex About RochePrinted course presentation, a printed spiral bound book of the IVDR Regulation (EU) 17/746, a short test and a certificate is included for all participants Course Leader/s Emma Axelsson, Senior Quality and Regulatory Consultant AnnaKarin Areskog, Senior Quality and Regulatory Consultant

The new IVDR will be implemented by notified bodies, which have the power to assess if products conform to these regulations before they are placed on the market As of early21, a handful of these have already been designated – including the BSI group in the Netherlands, and TÜV SÜD and Dekra in GermanyOverview Between the COVID19 pandemic and BREXIT negotiations, the rapidly approaching deadlines to comply with the new In Vitro Diagnostics Regulation (IVDR) may have a profound impact on market access to products and, ultimately, patient outcomesEurope's In Vitro Diagnostic Devices Regulation 17/746 (IVDR) will apply in the world's secondlargest medical device market starting in May 22

16h16h30 Break* 16h3017h30 Conformity Assessment Procedures(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 mediumsized enterprises that are active in this sector At the same time, this Regulation sets high standards of quality and safety for in vitroREGUL ATION (EU) 17/746 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 Apr il 17 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision

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The IVDR will require Notified Body intervention and review for 8090% of IVDs sold in Europe, compared to 10% that were reviewed under the IVDD There are no grandfathering provisions Moderate and highrisk IVDs must be certified to meet the IVDR by May 22 Low risk IVDs have until May 24 but still must meet IVDR QMS requirementsThe IVDR came into force on 25 May 17 Several implementing acts/guidance documents are being issued by the commission and are stipulated to complete some of the requirements to be met 3 When do medical device manufacturers need to comply to the new IVDR?The new IVDR will be implemented by notified bodies, which have the power to assess if products conform to these regulations before they are placed on the market As of early21, a handful of these have already been designated – including the BSI group in the Netherlands, and TÜV SÜD and Dekra in Germany

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The EU MDR & IVDR Virtual Summit is for you if you are looking to • Meet compliance requirements of EU MDR and IVDR before deadlines and maintain ongoing compliance • Simplify the process of finding a Notified Body and understand how they will conduct audits under new regulations • Meet new technical documentation requirementsThe IVDR was put in force by the European Union on May 25, 17 as a replacement for the existing In Vitro Diagnostics Directive (IVDD) The EU has mandated a fiveyear transition period, so IVD manufacturers will have until May 26, 22 to comply with all the new requirements However, the IVDR is regarded as unprecedented in both the numberThe IVDR also defines a CDx, for the first time in Europe, creating new challenges for device manufacturers and pharmaceutical companies producing CDx Under the previous directives, CDx could be selfcertified Now, considered a highrisk class C device, CDx requires conformity assessments by a notified body (NB), including increased clinical

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An early start is advised, given the expected pressure on notified bodies leading up to May 22 However, for many, IVDR raises more questions than answers Over the next three months, we will bring you a series of webinars to help you prepare for the transition, providing you with everything you need to know to get ready for IVDREU MDR and IVDR Guidance Documents A Complete List (Including PDF Download Links) November 18, Last Update February 26, 21 Shown below is a list of EU guidance documents endorsed by the Medical Device Coordination Group (MDCG) These documents are the ones we believe are most relevant to medical device and IVD manufacturersWe planned the IVDR transition of our CEmarked portfolio and allocated an adequate budget as well as the necessary resources to ensure that our ~2600 products (catalogue numbers) are IVDRready in time In the preparation phase, we reviewed the Roche CE IVD portfolio and assigned a classification of our IVD portfolio

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With major changes in legislation affecting device classification and requirements for technical documentation and clinical evidence, companies will need EU Medical Device Regulation (EU MDR) and EU In Vitro Diagnostics Regulation (EU IVDR) training Our courses provide comprehensive instruction on the EU MDR and EU IVDRThe IVDR has brought forward a new drive to establish "a robust, transparent, predictable and sustainable regulatory framework for in vitro diagnostic medical devices which ensures a high level of safety and health whilst supporting innovation"The IVDR came into force on 26 May 17 and has a 5year period of transition This ensures sufficient time for manufacturers and developers to utilise new pathways to market and for suppliers to adapt existing IVDs to comply with new requirements Quality, safety and reliability of IVDs will be improved by the IVDR

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The new EU In Vitro Diagnostics Regulation (EU IVDR) is not radically different from the current IVD Directive (IVDD) That's not to underestimate the amount of work that will be required to switch from the current IVDD to the new EU IVDRAccording to EU IVDR 17/746, Invitro Diagnostic Medical Device is 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 invitro for the examination of specimens, including blood and tissue donations, derived fromThe Regulation EU 17/746 (IVDR) replaces the "positive list" approach with new classifications rules, as defined in Annex VIII These classification rules define 4 different levels of risk classes (from the lowest risk class, ie class A, to the highest risk class, ie class D), based on the clinical risk profile of the IVD

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Key IVDR compliance requirements and challenges Creating an actionable roadmap to IVDR compliance is a complex process IVDR introduces new concepts and stricter requirements, including new activities such as clinical data gathering and usability engineering (UE) standards, compared to IVDD, which means manufacturers must now address issues including> IVDR requirements highlighted in yellow are more stringent than the corresponding IVDD requirement, so make sure to check the differences in the wording of both requirements as evidence originally created to satisfy the essential requirements may not be sufficientThe IVDR was officially published on 5 May 17 and came into force on 26 May 17 A transitional period of five years, until 26 May 22, applies to manufacturers of already approved medical products in order to meet the requirements of the IVDR The new regulation focuses on a new classification of IVDs into four risk classes, a more precise

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To conform to Annex I of IVDR 17/746, a GSPR checklist is a mandatory document and is one of the most fundamental preconditions to put any medical device on the EU market MDRG is currently creating an IVDR General Safety & Performance Requirements Checklist that contains a full table of the requirements, along with a list of ApplicableThe week long, online EU MDR & IVDR Virtual Summit will help quality, regulatory and product development professionals understand the new EU medical device regulations and strategic ways for companies to be both successful and competitive in the European market once MDR and IVDR go into effectAll IVDR Services With 40 years of experience as a provider of testing services for the safety and quality of in vitro diagnostic medical devices (IVD), we are a competent partner for transitioning to the IVDR In addition, we support manufacturers of IVD and medical devices with market access services into the European and international markets

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An early start is advised, given the expected pressure on notified bodies leading up to May 22 However, for many, IVDR raises more questions than answers Over the next three months, we will bring you a series of webinars to help you prepare for the transition, providing you with everything you need to know to get ready for IVDRThe two regulations (EU) 17/745 on medical devices (MDR) and (EU) 17/746 on invitro diagnostics (IVDR) came into force on 25 May 17 After a 3year transition period for the MDR (26 May ) and a 5year transition period for the IVDR (26 May 22), the respective regulations become validTo conform to Annex I of IVDR 17/746, a GSPR checklist is a mandatory document and is one of the most fundamental preconditions to put any medical device on the EU market MDRG is currently creating an IVDR General Safety & Performance Requirements Checklist that contains a full table of the requirements, along with a list of Applicable

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Planning for IVDR Compliance IVD manufacturers are familiar with structured systems in the development and management of products However, it is becoming clear that in order to develop and manage a product in accordance with the IVDR, there must be greater emphasis on, and appreciation of, the supporting processes that provide compliance evidenceWe planned the IVDR transition of our CEmarked portfolio and allocated an adequate budget as well as the necessary resources to ensure that our ~2600 products (catalogue numbers) are IVDRready in time In the preparation phase, we reviewed the Roche CE IVD portfolio and assigned a classification of our IVD portfolioThe new EU IVDR corrects this omission but really only brings European importers and distributors into line with already established practices for importers and distributors of medical devices in other geographies That leaves only a couple of requirements in the new EU IVDR which are truly novel

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On 13 November, the Medical Device Coordination Group (MDCG) published their long anticipated IVD Classification guidance document for IVDR (MDCG 16) 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 UnionThis guidance provides information on the EU Regulations for medical devices (MDR) and in vitro diagnostic medical devices (IVDR) From 1 January 21 the Medicines and Healthcare productsOn 13 November, the Medical Device Coordination Group (MDCG) published their long anticipated IVD Classification guidance document for IVDR (MDCG 16) 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

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The In Vitro Diagnostic Regulation (IVDR) (EU) 17/746 is the new EU legislation applicable to in vitro diagnostic (IVD) medical devices Entering into force on the 25 May 17 marking the start of a fiveyear transition period for manufacturers and economic operators, the IVDR replaces the EU In Vitro Diagnostics Directive (IVDD) 98/79/ECThe IVDR details the new PMPF requirements, including the dependency on the type and classification of the device being reviewed and how it should be defined within a Quality Management System (QMS) The Post Market Performance Followup (PMPF) is an important element of Post Market Surveillance (PMS)As with the MDR, the IVDR does not provide a "protection of the population" Meaning, all currently approved invitro diagnostics must be reviewed under the terms of the IVDR requirements after the valid IVDD certificate expires and must be then reapproved There is a fiveyear transition period for manufacturers with already approved IVDs

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The IVDR uses a riskbased classification system with classes ranging from A (the lowest risk) to D (the highest risk) Under IVDR requirements, a Notified Body must inspect Class ASterile as well as Classes B, C, and D products> IVDR requirements highlighted in yellow are more stringent than the corresponding IVDD requirement, so make sure to check the differences in the wording of both requirements as evidence originally created to satisfy the essential requirements may not be sufficientEU IVDR – Regulation (EU) 17/746 Your step by step guide to complying with the European Union's In Vitro Diagnostics Regulation of 17 Step 1 Decide the intended use and classification of the planned IVD device

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The Regulation EU 17/746 (IVDR) replaces the "positive list" approach with new classifications rules, as defined in Annex VIII These classification rules define 4 different levels of risk classes (from the lowest risk class, ie class A, to the highest risk class, ie class D), based on the clinical risk profile of the IVDThe IVDR also defines a CDx, for the first time in Europe, creating new challenges for device manufacturers and pharmaceutical companies producing CDx Under the previous directives, CDx could be selfcertified Now, considered a highrisk class C device, CDx requires conformity assessments by a notified body (NB), including increased clinicalThe InVitro Diagnostic Medical Devices Regulation (IVDR) will replace the existing InVitro Diagnostic Medical Devices Directive (IVDD) The IVDR was published in May 17, marking the start of a fiveyear period of transition from the IVDD For further information, please visit EURLex

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The European Union Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) came into effect as of May 26th, 17 The clock is ticking for current Medical Device manufacturers in the European marketplace to develop and implement strategies to be fully compliant The new In Vitro Diagnostic Regulation (IVDR) is complex and the

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