The New EU IVDR. Overview of the Main Changes & Clinical Data Requirements. Advance Regulatory Consulting Ltd.
|
|
- Harry Shields
- 6 years ago
- Views:
Transcription
1 Overview of the Main Changes & Clinical Data Requirements Advance Regulatory Consulting Ltd.
2 : Timeline: Entry in to force Q2 (Apr) 2017 Adoption: +6m NB s apply for designation IVDs classified as Class A can be placed on market under IVDR 5 yr. transition: Choice of IVDD or IVDR DoA: Apr 2022 CE Certificates can be renewed during the transition period: Max - DoA + 2 years (TBC) 5 year transition Manufacturer can apply either the IVDD or IVDR, however NB designation will be gating factor All products must be in compliance at the end of the transition period otherwise they must be taken off the market There is no expectation that there will be an extension
3 : Significant Changes: Regulation, not a Directive will apply uniformly in all member states although some areas are left to member states to legislate e.g. information and counselling in relation to genetic testing IVD Classification Rules based on GHTF/IMDRF Rules (JP, Aus, Can); IVD s will fall in to 1 of four classes; A to D with A being the lowest risk Requirements included for in-house tests/ldts Article 5(5) & Annex I Companion diagnostics specifically defined and have specific requirements New labelling requirements including UDI Increased Post-Market requirements Creation of Reference Labs for class D IVDs conformity Increased focus on and level of Clinical Evidence Requirement for a QP Specific requirements for Economic Operators and Distributors
4 : Annex VIII - Classification Rules:
5 Class C Assays In addition to meeting the general safety & performance requirements in Annex I of the regulation, Companion Dx must follow the procedures set out in Annex IX or X combined with XI:
6 Annex IX (Conformity Assessment) for CDx devices: In addition to the general requirements of Annex IX, Full Quality Assurance, 5.2 details requirements for Companion Diagnostic Devices: Member State CA for Medicines or the EMA shall be consulted by the Notified Body as part of the conformity assessment 60 days to provide opinion may be extended for a further 60 days on justified grounds EU technical documentation assessment certificate issued by Notified Body 30-day period for assessment of changes (New submission or Supplement) to the CDx is provided for along with a requirement for a supplement to the EU technical documentation assessment certificate to be issued by the NB
7 Definitions relevant to IVD performance evaluation: Clinical Evidence means the clinical data and performance evaluation results pertaining to a device, of sufficient amount and quality to allow a qualified assessment of whether the device achieves the intended clinical benefit(s) and safety, when used as intended by the manufacturer; clinical benefit of an in-vitro diagnostic device means the positive impact of a device related to its function (e.g. screening, monitoring, diagnosis or aid to diagnosis of patients) or a positive impact on patient management or public health; 'scientific validity of an analyte' means the association of an analyte to a clinical condition or a physiological state; 'analytical performance' means the ability of a device to correctly detect or measure a particular analyte;
8 Definitions relevant to IVD performance evaluation: Performance of a device means the the ability of a device to achieve its intended purpose as claimed by the manufacturer. It consists of the analytical and, where applicable, the clinical performance supporting the intended purpose of the device; clinical performance' means the ability of a device to yield results that are correlated with a particular clinical condition or a physiological or pathological process or state in accordance with the target population and intended user; 'interventional clinical performance study' means a clinical performance study where the test results may influence patient management decisions and/or may be used to guide treatment;
9 Performance Evaluation and PMPF: Performance Evaluation is a continuous process of data assessment and analysis PE covers: Scientific Validity Analytical Performance & Clinical Performance Requires manufacturer to generate a PE Plan and Report (incorporating all 3 pillars above ) and to continuously conduct and document the performance evaluation Must be objective considering favourable and unfavourable data As a general rule, clinical evidence should be sourced from performance studies to be carried out under the responsibility of a study sponsor (manufacturer or other legal or natural person taking responsibility for the PE study):
10 Establishing Scientific Validity per Annex XIII (PE 1.2.1): The manufacturer shall demonstrate the scientific validity based on one or a combination of the following sources: relevant information on the scientific validity of devices measuring the same analyte or marker; scientific (peer-reviewed) literature; consensus expert opinions/positions from relevant professional associations; results from proof of concept studies; results from clinical performance studies. Much easier for an established biomarker!!
11 Establishing Analytical Performance per Annex XIII (PE 1.2.2): The manufacturer shall demonstrate the analytical performance of the device according to all the parameters described in point (a) of Section 6(1) of Annex 1 (General Principles of safety and performance); Analytical sensitivity; Analytical Specificity; Trueness (bias); Precision (repeatability and reproducibility); Accuracy (resulting from trueness and precision); Limits of Detection and Quantitation; Measuring Range; Linearity; Cut-off; As well as determination of appropriate criteria for specimen collection and handling and control of known relevant Endogenous and Exogenous interference and Cross-reactions; Unless any omission can be justified as not applicable. As a general rule, the analytical performance shall always be demonstrated on the basis of analytical performance studies.
12 Establishing Analytical Performance per Annex XIII (PE 1.2.2): For Novel Markers: May not be possible to demonstrate trueness as certified reference materials or reference measurement procedures may not be available. Different approaches may be used e.g. comparison to composite reference methods or some other well documented methods. If not possible; A Clinical Performance Study comparing performance of the novel device with current clinical practice is required.
13 Establishing Clinical Performance per Annex XIII (PE 1.2.3): The manufacturer shall demonstrate the clinical performance of the device according to all the parameters described in point (b) of Section 6.1. of Annex I: diagnostic sensitivity, diagnostic specificity, positive predictive value, negative predictive value, likelihood ratio, expected values in normal and affected populations. Unless any omission be justified as not applicable. Clinical Performance shall be based on one or a combination of the following: clinical performance studies; scientific peer-reviewed literature; published experience gained by routine diagnostic testing.
14 Establishing Clinical Performance per Annex XIII (PE 1.2.3): Clinical performance studies shall be performed unless it is duly justified to rely on other sources of clinical performance data.
15 Establishing Clinical Performance per Annex XIII (PE 1.2.3): Clinical Performance Studies 2 Annex XIII: Purpose: To establish or confirm aspects of device performance which can t be determined by analytical performance studies Used to demonstrate compliance with the relevant general safety and performance requirements wrt clinical performance Every step: from first consideration of the need to publication of the results shall be carried out in accordance with recognised ethical principles.
16 Establishing Clinical Performance per Annex XIII (PE 1.2.3): Clinical Performance Studies Contd: Studies shall be: designed in such a way as to maximize the relevance of the data while minimising potential bias Performed on the basis of a Clinical Performance Study Plan which defines: the rationale, objectives, design methodology, monitoring, statistical considerations, organisation and conduct of the study and shall contain
17 Establishing Clinical Performance per Annex XIII (PE 1.2.3): Clinical Performance Study Plan: a). Identification of the CP study and the CPSP b). Identification of the Sponsor c). Identification of the investigator(s), site(s), location and number of lay persons (self-test devices), d). starting date and duration e). Identification and description of device, intended use, analytes/markers, metrological traceability f). Specimen type(s) g). Synopsis: design type (longitudinal/cross sectional/interventional etc.), objectives, hypotheses, reference to SoA/clinical practice
18 Establishing Clinical Performance per Annex XIII (PE 1.2.3): Clinical Performance Study Plan Contd: h). Risks and benefits i). IFU including training requirements, other devices or medicinal products to be used in the study j). Description of the justification for the design, scientific robustness and validity, statistical design etc. (SAP) k). Analytical performance l). Parameters of clinical performance m). Performance study population n). Information on the use of data from left-over samples o). Monitoring Plan
19 Establishing Clinical Performance per Annex XIII (PE 1.2.3) Clinical Performance Study Plan Contd: p). Data Management q). Decision Algorithms r). Policy regarding amendments or deviations with a clear prohibition of the use of waivers s). Device Accountability t). Ethical & regulatory compliance statement u). IC Process including Patient Info sheet and ICF v). Safety recording and reporting w). Procedures for suspension or early termination of the CPS x). Follow up procedures
20 Establishing Clinical Performance per Annex XIII (PE 1.2.3): Clinical Performance Study Plan Contd: y). Policy regarding reporting and publication in accordance with legal and ethical requirements z). List of technical and functional features of the device indicating those that are covered by the performance study. (aa) Bibliography. Where any of the above-mentioned elements are not deemed appropriate for inclusion in the CPSP due to the specific study design chosen (e.g. use of left-over samples versus interventional clinical performance studies), a justification shall be provided.
21 Establishing Clinical Performance per Annex XII (PE 1.2.3): Clinical Performance Study Report: signed by a medical practitioner or any other authorised person responsible, shall contain documented information on the clinical performance study protocol plan, results and conclusions of the clinical performance study, including negative findings. The results and conclusions shall be transparent, free of bias and clinically relevant. The report shall contain sufficient information to enable it to be understood by an independent party without reference to other documents.
22 Establishing Clinical Performance per Annex XII (PE 1.2.3): Clinical Performance Study Report: The report shall also include, as appropriate, any protocol amendments or deviations, and data exclusions with the appropriate rationale.
23 Post-Market Performance Follow-up (PMPF) per Annex XIII: Manufacturer shall proactively collect and evaluate performance and relevant scientific data from the use of a device which bears the CE-mark, placed on the market or put in to service To confirm safety, performance and scientific validity throughout the lifetime of the device Performed in accordance with a documented PMPF plan Amongst other things, confirm safety and performance and: Assuring continued acceptability of the clinical evidence and of the benefit/risk ratio
24 Interventional and high-risk Clinical Performance Studies per Annex XIV: Sponsor shall draw up and submit application in accordance with Article 48a including: Application form Investigator s Brochure Clinical Performance Study Plan Other information including; Declaration of device conformity and ethical compliance (similar to Annex VIII in directive) REC opinion Insurance and indemnification ICF and patient information Data protection etc.
25 : CDx Rx Development Timelines: IVDR Published DoA - All IVD's must comply 2021 Q NB Designation Complete 2019 Q m c. Q Rx-CDx Development & Approval Timeline (Standard) IVDR Published Q DoA Phase II/III Trial 2021 Data Analysis, Rx - CDx Submission & Review Launch We need to be implementing the new clinical requirements NOW!!
26 Significant Changes: QUESTIONS?
IVDR Workshop Diagnostik Akademie, Sven Hoffmann Global Head of Technical Competence Center IVD TÜV Rheinland LGA Products GmbH
IVDR Workshop Diagnostik Akademie, 19.10.2017 Sven Hoffmann Global Head of Technical Competence Center IVD TÜV Rheinland LGA Products GmbH Agenda Kapitel Thema Dauer Referent 1 Clinical Evidence 2 Performance
More informationCompanion Diagnostics (CDx) and personalized Medicine
Companion Diagnostics (CDx) and personalized Medicine Rolf Thermann TÜV Rheinland LGA Products GmbH LISAvienna Business Treff: Regulatory Konferenz für Medizinprodukte und IVD Wien, 06.11.2018 Companion
More informationIVD Regulation 2017/746
IVD Regulation 2017/746 Dr. Anne Van Nerom Famhp 2017-06-13 Recast-symposium Auditorium Storck (Eurostation II) Rue Juliette Wytsmanstraat 14 1050 Brussels Belgium T +32 2 642 51 11 F +32 2 642 50 01 email:
More informationIVD Regulation Update
IVD Regulation Update BSI Annual Roadshow October 2016 1 IVDR Overview - Update 2 Classification & Conformity Assessment Medical Devices Coordination Group (MDCG) Electronic systems (Eudamed) Summary of
More informationIVDR Update Get Ready for the Ride. MassMEDIC World MedTech Regulatory Update
IVDR Update Get Ready for the Ride MassMEDIC World MedTech Regulatory Update Carol C. Ryerson, Ph.D. Sr. Principal Advisor, Regulatory Affairs Jun 8, 2017 Agenda Overview of the IVDR (EU) 2017/746 Business
More informationChanges to the Regulation of IVDs in Europe. Copyright 2012 BSI. All rights reserved.
Changes to the Regulation of IVDs in Europe Copyright 2012 BSI. All rights reserved. Caution The new regulations are draft and subject to change Further details will be added later pre and post application
More informationManufacturers of in vitro Diagnostic
European Commission Factsheet for Manufacturers of in vitro Diagnostic Medical Devices This Factsheet is aimed at manufacturers of in vitro diagnostic medical devices. For information on the impact of
More informationManufacturers of In-Vitro Diagnostic
Ref. Ares(2018)3873780-20/07/2018 Factsheet for Manufacturers of In-Vitro Diagnostic Medical Devices This Factsheet is aimed at manufacturers of in-vitro diagnostic medical devices. For information on
More informationIVD Regulation What you need to know. Erica Conway 5 th May 2017
IVD Regulation What you need to know Erica Conway 5 th May 2017 1 First Question: What is the difference between a Directive and a Regulation? EU Directive: Applicable to all Member States Sets certain
More informationIVDR Breakout. Copyright 2017 BSI. All rights reserved.
IVDR Breakout 1 IVDR Annex I (SPRs) & Annex II (Tech documentation) 2 IVDR Annex I General Safety & performance requirements 3 Overview Context of the General Safety & Performance Requirements (SPRs) [our
More informationUpdate on the IVDR. Sue Spencer
Update on the IVDR Sue Spencer Caution The new regulations are draft the principles have now been agreed but the Annexes are subject to minor changes Further details will be added later pre and post application
More informationPerspective: New European IVD Regulations New Concepts for Market Authorizations and Product Launch Schedules
Perspective: New European IVD Regulations New Concepts for Market Authorizations and Product Launch Schedules Planning for Efficiencies of Data, Resources, and Timelines A PRECISION BRIEF Introduction
More informationImpact of the IVD Regulations. Barbara Fallowfield Managing Director
Impact of the IVD Regulations Barbara Fallowfield Managing Director What will I cover today? Timelines Key Changes Classification Clinical Evidence Requirements Third Parties Vigilance and Post Marketing
More informationThe EU s In Vitro Diagnostics (IVD) Regulation:
The EU s In Vitro Diagnostics (IVD) Regulation: a summary of the regulatory requirements for software and genetic tests The European Union (EU) s In Vitro Diagnostics (IVD) Regulation (of 5 April 2017)
More informationDr. Wim Huisman Chair Committee Quality and Regulations EFLM Bergen Norway, 14 March 2017
Dr. Wim Huisman Chair Committee Quality and Regulations EFLM Bergen Norway, 14 March 2017 Determines requirements for admission to EU market valid since 1998 Conformity indicated by CE mark Certainly no
More informationImpact of the MD/IVD Regulations on Quality Management Systems
Impact of the MD/IVD Regulations on Quality Management Systems Dirk Stynen, Ph. D. President Qarad RMD 2018 Brussels In this presentation: focus on In Vitro Diagnostic Devices... but the same applies to
More informationUpdate on Regulatory Environment- Europe Experience with 2007/47/EC M5 & Discussions on Possible Recast of EU Medical Device Regulations
Update on Regulatory Environment- Europe Experience with 2007/47/EC M5 & Discussions on Possible Recast of EU Medical Device Regulations Paul Brooks Vice President Healthcare, Americas Presentation to:
More informationRecent Trends in Companion Diagnostic Test Development Partnerships
Recent Trends in Companion Diagnostic Test Development Partnerships Andrew S. Thompson, PhD, Director of Therapy and Analysis, GlobalData Medical, London Tyler Fletcher, Global Head, GlobalData Medical,
More informationDRAFT MEDICAL DEVICE GUIDANCE DOCUMENT
November 2015 DRAFT DRAFT MEDICAL DEVICE GUIDANCE DOCUMENT REQUIREMENTS FOR LABELLING OF MEDICAL DEVICES Medical Device Authority MINISTRY OF HEALTH MALAYSIA Contents Page Preface... iii 1 Introduction.
More informationCOMMISSION RECOMMENDATION. of XXX. on the audits and assessments performed by notified bodies in the field of medical devices
EUROPEAN COMMISSION Brussels, XXX [ ](2013) XXX draft COMMISSION RECOMMENDATION of XXX on the audits and assessments performed by notified bodies in the field of medical devices (Text with EEA relevance)
More informationManufacturers. Factsheet for. of Medical Devices. Medical Devices Regulation (MDR) background. Act now to be ready on time!
Ref. Ares(2018)3873669-20/07/2018 Factsheet for Manufacturers of Medical Devices This Factsheet is aimed at manufacturers of medical devices. For a general overview of the impact of the In-Vitro Medical
More informationManufacturers. Factsheet for. of Medical Devices. Medical Devices Regulation (MDR) background. Act now to be ready on time!
European Commission Factsheet for Manufacturers of Medical Devices This Factsheet is aimed at manufacturers of medical devices. For a general overview of the impact of the In Vitro Medical Devices Regulation
More informationAn introductory guide to the medical device regulation (MDR) and the in vitro diagnostic medical device regulation (IVDR)
An introductory guide to the medical device regulation (MDR) and the in vitro diagnostic medical device regulation (IVDR) devices.implementation@mhra.gov.uk 1 Introduction - How to use this guide Navigate
More informationWhat you need to know about the new European IVD Regulation
What you need to know about the new European IVD Regulation Sue Spencer Stefan Burde September 2014 What you need to know about the new European IVD Regulation What is it? Why do we need it? When is it
More informationMedical Device Regulation Overview
Medical Device Regulation Overview Dr Haidong Liang, PhD Clifton Medtech Consulting info@cliftonmedtech.com http://cliftonmedtech.com/ What is the issue? Existing EU Directives dating back to the 1990s
More informationASQ Tappan Zee Section Medical Devices, New Regulations and Standards. 26 th September / V. Fischer / Rev. 01
ASQ Tappan Zee Section Medical Devices, New Regulations and Standards 26 th September / V. Fischer / Rev. 01 Agenda Medical Device, General Aspects Examples Quality System(s) New Regulations & Standards
More informationGuide for Manufacturers and Sponsors on Clinical Investigations Carried Out in Ireland
Guide for Manufacturers and Sponsors on Clinical Investigations Carried Out in Ireland AUT-G0095-1 15 AUGUST 2014 This guide does not purport to be an interpretation of law and/or regulations and is for
More informationPROPOSED FINAL DOCUMENT
AHWP/WG1a/PF004:2013 PROPOSED FINAL DOCUMENT Title: Author: Comparison between the GHTF Summary Technical Documentation (STED) formats for Medical Devices and In Vitro Diagnostic Medical Devices and the
More informationMEDICAL DEVICE. Technical file.
MEDICAL DEVICE Technical file www.icaro-research.eu ICARO MDTF v1.0 1 Mar 2016 1. Do you plan to launch your medical device in Europe? If you re reading this, chances are good that you re considering introducing
More informationSelf-Care Medical Devices Framework. Dr. Simone Breitkopf Head HEOR, Governmental and Public Affairs
Self-Care Medical Devices Framework Dr. Simone Breitkopf Head HEOR, Governmental and Public Affairs Disclaimer The view and opinions expressed in the following PowerPoint slides are those of the individual
More informationBiomarker Regulation. Regulator s perspective. Jan Müller-Berghaus
www.pei.de Biomarker Regulation Regulator s perspective Jan Müller-Berghaus The views presented here are my own and do not necessarily reflect the views of the Paul-Ehrlich-Institut or any other regulatory
More informationRSC/CT Det. no. 1/2013
RSC/CT Det. no. 1/2013 Protocol 1631-P The English version of this Determination was prepared in order to help comprehension by non-italian mother tongue users, but is NOT an official document. Please
More informationEffects of the European MDR on the Quality Management System. Karl-Heinz Spohn
Effects of the European MDR on the Quality Management System Karl-Heinz Spohn 1 Karl-Heinz Spohn Senior Consultant Certified Electrical Engineer with a specialization in Data Electronics. Since 1981 working
More informationShort intro to the MDR & IVDR (C)2018 QAdvis AB
Short intro to the MDR & IVDR 2018-06-11 1 , MDR Major changes for medical device and IVD device industry EU regulations Non-EU regulations Standards Brexit Affecting all stakeholders: manufactuers, distributors,
More informationConformity Assessment of Medical Devices Under The New MDR
Conformity Assessment of Medical Devices Under The New MDR (Dec. 06, 2017) Tina Lochner, Medcert Slide 1 Agenda Scope: MDR Article 1 and 2 MDR Conformity Assessment: MHRA* (UK Competent Authority) MDR
More informationReady or Not: The New Medical Device Regulations Are Here!
Ready or Not: The New Medical Device Regulations Are Here! Felicia R Cochran, PhD, CMPP TM feliciacochran@earthlink.net FR Cochran 1 General Disclaimers This presentation represents the knowledge, professional
More informationNew EU Medical Device Regulations.are you ready? Angela Stokes Senior Director Regulatory Affairs March 2017
New EU Medical Device Regulations.are you ready? Angela Stokes Senior Director Regulatory Affairs March 2017 Agenda Background Notified Bodies Reassessment Classification Changes Technical Documentation
More informationIntroduction to the new regulatory framework for medical devices and in vitro diagnostic medical devices
Introduction to the new regulatory framework for medical devices and in vitro diagnostic medical devices Vincent Houdry DG for Internal Market, Industry, Entrepreneurship and SMEs European Commission Key
More informationGUIDELINES ON MEDICAL DEVICES GUIDE FOR COMPETENT AUTHORITIES IN MAKING AN ASSESSMENT OF CLINICAL INVESTIGATION NOTIFICATION
EUROPEAN COMMISSION ENTERPRISE AND INDUSTRY DIRECTORATE-GENERAL Consumer goods Cosmetics and Medical Devices MEDDEV 2.7.2 December 2008 GUIDELINES ON MEDICAL DEVICES GUIDE FOR COMPETENT AUTHORITIES IN
More informationMEDICAL DEVICE GUIDANCE DOCUMENT REQUIREMENTS FOR LABELLING OF MEDICAL DEVICES
November 2018 Third Edition MEDICAL DEVICE GUIDANCE DOCUMENT REQUIREMENTS FOR LABELLING OF MEDICAL DEVICES Medical Device Authority MINISTRY OF HEALTH MALAYSIA Contents Page Preface.... iii 1 Introduction....
More informationMEDICAL DEVICE GUIDANCE DOCUMENT REQUIREMENTS FOR LABELLING OF MEDICAL DEVICES
January 2018 Second Edition MEDICAL DEVICE GUIDANCE DOCUMENT REQUIREMENTS FOR LABELLING OF MEDICAL DEVICES Medical Device Authority MINISTRY OF HEALTH MALAYSIA Contents Page Preface.... iii 1 Introduction....
More informationUNICEF TECHNICAL REQUIREMENTS FOR MEDICAL DEVICES (MD)
UNICEF TECHNICAL REQUIREMENTS FOR MEDICAL DEVICES (MD) A. Background January 2019 UNICEF Technical requirements for Medical Devices are the requirements that suppliers need to comply with, and that products
More informationVERSION: 21 st June Date of Publication: 15 th March C/ CAMPEZO, 1 EDIFICIO MADRID Tel.: Fax:
Memorandum on Collaboration and Exchange of Information between the Spanish Agency of Medicinal Products and Medical Devices and Ethics Committees for investigation with medicinal products VERSION: 21
More informationFactory CRO. Factory CRO for Medical Devices & IVDs
DCRF Jaarcongres, 26 september 2018 MDR 2020 - De impact op onderzoek met medische hulpmiddelen Klinische evaluatie en klinische studies Niels van Tienen 1 Bio Current role Director Clinical Operations,
More informationCommission notice on the application of Articles 3, 5 and 7 of Regulation (EC) No 141/2000 on orphan medicinal products (2016/C 424/03)
18.11.2016 EN Official Journal of the European Union C 424/3 Commission notice on the application of Articles 3, 5 and 7 of Regulation (EC) No 141/2000 on orphan medicinal products (2016/C 424/03) A. INTRODUCTION
More informationInterface between medicinal product and medical devices development - Update on EMA implementation of the new medical devices legislation
Interface between medicinal product and medical devices development - Update on EMA implementation of the new medical devices legislation Combined medicines and devices developments SME info day, 26 October
More informationCompanion diagnostics and the IVD Directive 98/79/EC + revision
Companion diagnostics and the IVD Directive 98/79/EC + revision European Perspectives in Personalised Medicine Square-Brussels Meeting Centre Brussels, Belgium 12-13 May 2011 Dr. Anne Van Nerom Rue Juliette
More informationMedical Devices & In-Vitro Diagnostics
Medical Devices & In-Vitro Diagnostics The new EU regulations in a nutshell Robert Geertsma, Senior Scientist, RIVM Robert.Geertsma@rivm.nl Ricco Buitink Team Coordinator Medical Devices MoH NL Content
More informationGuide to the in-vitro diagnostic medical devices legislation
Guide to the in-vitro diagnostic medical devices legislation Item Type Other Authors Irish Medicines Board (IMB) Publisher Irish Medicines Board (IMB) Download date 17/10/2018 04:46:25 Link to Item http://hdl.handle.net/10147/97003
More informationQMS Aspects of the MDR (& IVDR)
QMS Aspects of the MDR (& IVDR) Vicky Medley Global QMS Manager Medical Devices 27 February 2018 Copyright 2018 BSI. All rights reserved This Presentation 1. The clock is ticking! 2. Dates & priorities
More informationGUIDELINES ON MEDICAL DEVICES
EUROPEAN COMMISSION DIRECTORATE GENERAL for HEALTH and CONSUMERS Consumer Affairs Cosmetics and Medical Devices MEDDEV 2.7/4 December 2010 GUIDELINES ON MEDICAL DEVICES GUIDELINES ON CLINICAL INVESTIGATION:
More informationGuidance on legislation. Clinical investigations of medical devices guidance for investigators
Clinical investigations of medical devices guidance for investigators November 2013 Contents Introduction...3 1 Research ethics committee approval...3 2 Grounds for objection...4 3 Labelling of medical
More informationRD SOP32 Gaining MHRA Approval
RD SOP32 Gaining MHRA Approval Version Number: 1.0 Name of originator/author: Dr Lloyd Gregory Name of responsible committee: R&I Committee Name of executive lead: Medical Director & Director of Quality
More informationThe New EU Medical Device Regulation (MDR) An Active Device Lifecycle Approach Implementation and Remediation Activities
visit usdm.com The New EU Medical Device Regulation (MDR) An Active Device Lifecycle Approach Implementation and Remediation Activities Jay Crowley VP and Practice Lead UDI Services and Solutions jcrowley@usdm.com
More informationPanel Discussion: European Medical Device Regulations Preparing for the Storm Moderator: Lenita Y. Sims Spears, Senior Quality Consultant/Senior
Panel Discussion: European Medical Device Regulations Preparing for the Storm Moderator: Lenita Y. Sims Spears, Senior Quality Consultant/Senior Regulatory and Compliance Counsel, BioTeknica Panelists:
More informationClassification under the IVD Regulation
Classification under the IVD Regulation Nick Baker Head of IVD Notified Body LRQA Ltd Improving performance, reducing risk IVD regulation shift in regulatory scrutiny Under the current IVD directive 10-15%
More informationThe challenges of software medical device regulation.
The challenges of software medical device regulation. david.grainger@mhra.gov.uk Introduction A brief history of software device regulation A look at the new device regulations 2 Current framework In Vitro
More informationRecast Medical Device directives Impacts on materiovigilance
Recast Medical Device directives Impacts on materiovigilance Journée Vigilance 23.03.2017 Valérie Nys Revision of the EU Medical Devices Legislation Directive 90/385/EEC on active implantable medical devices
More informationA Risk-based Approach for In Vitro Companion Diagnostics Device FDA Approval Process Associated with Therapies that have Breakthrough Designation
A Risk-based Approach for In Vitro Companion Diagnostics Device FDA Approval Process Associated with Therapies that have Breakthrough Designation A Risk-based Approach for In Vitro Companion Diagnostics
More informationAPPLICATION FORM. Application for a Recognised Research Ethics Committee (REC) Opinion on a Clinical Trial on a Medicinal Product for Human Use.
APPLICATION FORM Application for a Recognised Research Ethics Committee (REC) Opinion on a Clinical Trial on a Medicinal Product for Human Use. Form 1 This application form should be completed and submitted
More informationGENERAL AND ORGANISATIONAL REQUIREMENTS
NBOG working document applicable for MDR and IVDR WD 2017-1 Draft list of documents to be submitted in the application for designation as a notified body under Regulation (EU) 2017/745 and Regulation (EU)
More informationDangers of Over-Regulation (or Under- Regulation) of Genetic Testing at EU level. David Barton
Dangers of Over-Regulation (or Under- Regulation) of Genetic Testing at EU level David Barton Department of Clinical Genetics Our Lady s Children s Hospital Dublin Background Diagnostic tests, known as
More informationState Institute for Control of Drugs-/ Státní ústav pro control léčiv (SÚKL) Regulatory and ethics bodies involved in approval process
Medical Devices - CZECH REPUBLIC Competent authority Contact Details Contact Name 1 State Institute for Control of Drugs-/ Státní ústav pro control léčiv (SÚKL) Phone +420 272 185 111 Fax +420 271 732
More informationMedDev Rev 4 Medical Devices Regulation. Clinical Evidence Requirements Key Changes and Clarifications. Alan Eller 21 March 2017
MedDev 2.7.1 Rev 4 Medical Devices Regulation Clinical Evidence Requirements Key Changes and Clarifications Alan Eller 21 March 2017 Copyright 2016 BSI. All rights reserved. 1 Clinical Evidence Requirements
More informationMEDICAL DEVICE CLINICAL INVESTIGATIONS AND ISO 14155
MEDICAL DEVICE CLINICAL INVESTIGATIONS AND ISO 14155 EXECUTIVE SUMMARY Medical device regulations around the world generally require manufacturers of most types of medical devices to supply data as part
More informationBridging gaps: medical device directive vs regulation. Geert Corstens 1 November 2018
Bridging gaps: medical device directive vs regulation Geert Corstens 1 November 2018 Agenda Current Medical Device regulatory landscape New Medical Device Regulation EU Interaction & impact Medical device
More informationINDUSTRY S VIEW ON THE FUTURE OF IN VITRO DIAGNOSTIC (IVD) LEGISLATION IN EUROPE. May 2013 SPECIAL REPRINT. By Jesús Rueda Rodríguez, EDMA
May 2013 SPECIAL REPRINT INDUSTRY S VIEW ON THE FUTURE OF IN VITRO DIAGNOSTIC (IVD) LEGISLATION IN EUROPE By Jesús Rueda Rodríguez, EDMA Reproduced with the kind permission of Global Regulatory Press from
More informationSpecific Accreditation Criteria
Specific Accreditation Criteria ISO/IEC 17025 Application Document Materials - Annex Characterisation of industrial materials - General July 2018 Copyright National Association of Testing Authorities,
More informationClinical Trials Environment EU Legislation: Ausblick auf die neue Gesetzgebung für klinische Prüfungen
The Future of the Regulatory Berlin, 31.05.2013 Clinical Trials Environment EU Legislation: Qualifizierungstag für Study Nurses Ausblick auf die neue Gesetzgebung für klinische Prüfungen Dr. med. Ingrid
More informationof 17 October 2001 (Status as of 26 November 2017)
English is not an official language of the Swiss Confederation. This translation is provided for information purposes only and has no legal force. Medical Devices Ordinance (MedDO) 812.213 of 17 October
More informationMaking the case for Personalised Medicine
Making the case for Personalised Medicine The biopharmaceutical industry perspective Barbara Freischem Executive Director European Biopharmaceutical Enterprises Who we are EBE represents the voice of biopharmaceutical
More informationBSI Audits for MDR Certification
BSI Audits for MDR Certification Quality System Audits Unannounced Audits (ongoing per MDD / MDR) No changes as a result of MDR / IVDR New frequencies already applied Once per 3 years for Class III & Implants
More informationGuidance on the Information Required for Notified Body Medical Device Personnel Involved in Conformity Assessment
NBOG s Best Practice Guide applicable for AIMDD, MDD, and IVDD 2014-2 Guidance on the Information Required for Notified Body Medical Device Personnel Involved in Conformity Assessment Activities Personnel
More informationThe new EU clinical trial regulation 536/2014 : Low interventional trials
The new EU clinical trial regulation 536/2014 : Low interventional trials KCE Greet Musch Brussels, 28 th November 2017 Agenda: 1: Legal framework EU regulation 536/2014 Q&A document : algorithm 2: Risk
More informationChanges in EU Clinical Data Requirements and Expectations
Changes in EU Clinical Data Requirements and Expectations Waltham, MA (USA) 19 June 2018 Maria E. Donawa, M.D. President, Donawa Lifescience Consulting Srl Rome, Italy Introduction Meeting European clinical
More informationSTANDARD OPERATING PROCEDURE FOR RESEARCH. 14. Amendments to Research Studies
Basildon and Thurrock University Hospitals NHS FT Research & Development APPROVED STANDARD OPERATING PROCEDURE FOR RESEARCH 1. BACKGROUND 14. Amendments to Research Studies Amendments are changes made
More informationDirective 2004/22/EC Common application
WELMEC 8.21 Issue 1 May 2012 WELMEC European cooperation in legal metrology Directive 2004/22/EC Common application WELMEC European cooperation in legal metrology WELMEC is a co-operation between the legal
More informationTechnical Guidance on Development of In Vitro Companion Diagnostics and Corresponding Therapeutic Products
Administrative Notice December 26, 2013 To: Division of Pharmaceutical Affairs, Prefectural Health Department (Bureau) From: Evaluation and Licensing Division, Pharmaceutical and Food Safety Bureau Ministry
More informationThe New EU IVD Regulation & Brexit. Doris-Ann Williams BIVDA
The New EU IVD Regulation & Brexit Doris-Ann Williams BIVDA Agenda 1 2 3 4 5 Some background: Directive vs Regulation Purpose of IVDR Regulatory Changes Impact within the supply chain Required Managerial
More informationCo-ordination of Notified Bodies Medical Devices (NB-MED) on Council Directives 90/385/EEC, 93/42/EEC and 98/79/EC
Chapter: 2.7 Clinical investigations, clinical evaluation Text:... Key words: Clinical data, Evaluation 1. Introduction and purpose It is the primary purpose of this document to provide guidance to Notified
More informationRegulatory Affairs in Medical Technology
Regulatory Affairs in Medical Technology Medical Device Regulation: Implementation on European Level, First Results Dr. Matthias Neumann Federal Ministry of Health Lübeck 2018 Summer Academy on Medical
More informationMedical Device Regulatory Framework
Medical Device Regulatory Framework 24 July 2015 SAMED Member Meeting Contents 1. Context 2. Regulatory framework Key concepts Process 3. Changes 4. What to do? 1. Context Act 101 of 1965 as amended Draft
More informationDue diligence in the European medical devices industry
Due diligence in the European medical devices industry Alison Dennis, Reed Smith LLP www.practicallaw.com/0-205-5707 As the medical devices industry is highly regulated, determining a target company's
More informationThis template is to be used by companies willing to submit an overview of relevant
Briefing book template for pharmaceuticals to support a multi-hta Early Dialogue (ED) December 13 th, 2013 This template is to be used by companies willing to submit an overview of relevant information
More informationGUIDELINES ON MEDICAL DEVICES. IVD GUIDANCE : Research Use Only products A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES
Ref. Ares(2015)2031363-13/05/2015 EUROPEAN COMMISSION ENTERPRISE DIRECTORATE-GENERAL Single Market : regulatory environment, standardisation and New Approach Pressure equipment, medical devices, metrology
More informationEuropean Working Group on Ethical Public Procurement
European Working Group on Ethical Public Procurement and proposals for amendments to the European Commission proposal for the Directive on Public Procurement COM(2011) 896 final, 20.12.2011 Proposals of
More informationDanish Act on Clinical Trials of Medicinal Products 1
This is a translation of an extract of the Danish Act on Clinical Trials of Medicinal Products (Danish title: Lov om kliniske forsøg med lægemidler). Only the Danish version has legal validity. Adopted
More informationANNEX. CHAPTER I General principles
ANNEX REGULATIONS on the authorisation by the NMA of clinical trials/notification to the National Medicines Agency of non-interventional studies on medicinal products for human use in Romania CHAPTER I
More informationThe upcoming EU MDR. Gert Bos. - key changes overview. Executive director & Partner. ..the practical approach
The upcoming EU MDR - key changes overview Gert Bos Executive director & Partner A global leading medical device consultancy group Europe - Amsterdam (HQ) USA - Boston - San Francisco China Nanjing Copyright
More informationBrussels, C(2017) 8179 final. Guidelines
EUROPEAN COMMISSION Brussels, 8.12.2017 C(2017) 8179 final Guidelines Detailed Commission guidelines on good manufacturing practice for investigational medicinal products for human use, pursuant to the
More informationUKAS Supplement for the Accreditation of Environmental Verifiers for EMAS (the EU Eco Management and Audit Scheme Regulation 1221/2009)
CIS 11 Edition 1 September 2016 UKAS Supplement for the Accreditation of Environmental Verifiers for EMAS (the EU Eco Management and Audit Scheme Regulation 1221/2009) CIS 11 / Edition: 1 Page 1 of 7 Contents
More informationCAMD Implementation Taskforce
CAMD Implementation Taskforce Medical Devices Regulation/In-vitro Diagnostics Regulation (MDR/IVDR) Roadmap Overview and proposed terms of reference The Competent Authorities for Medical Devices (CAMD)
More informationHealth Registration and Training Center (HRTC/ENKK) , Mail: 1380 P.O. Box 1188 (Street: Zrinyi u. 3.
Medical Devices - HUNGARY Competent authority Contact Details Contact Name 1 Health Registration and Training Center (HRTC/ENKK) Contact Name 2 Department of Medical Devices Phone +36 1 235-7914, +36 1
More informationDeveloping a Companion Diagnostics in parallel to a medicinal product Legal and Regulatory requirements in Europe and in the US
Developing a Companion Diagnostics in parallel to a medicinal product Legal and Regulatory requirements in Europe and in the US Companion Diagnostics are in vitro diagnostic medical devices device specifically
More informationMedical Device Regulatory Framework 9 SEPTEMBER 2015 FUNDISA CONFERENCE JANE ROGERS
Medical Device Regulatory Framework 9 SEPTEMBER 2015 FUNDISA CONFERENCE JANE ROGERS Key Topics Definitions Essential Principles Classification Conformity Assessment Framework License to Manufacture, Import,
More informationGUIDELINES ON MEDICAL DEVICES CLINICAL EVALUATION: A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES
EUROPEAN COMMISSION ENTERPRISE AND INDUSTRY DIRECTORATE GENERAL Consumer Goods Cosmetics and Medical Devices MEDDEV. 2.7.1 Rev.3 December 2009 GUIDELINES ON MEDICAL DEVICES CLINICAL EVALUATION: A GUIDE
More informationStandards of proficiency. Biomedical scientists
Standards of proficiency Biomedical scientists Contents Foreword 1 Introduction 3 Standards of proficiency 7 Foreword We are pleased to present the Health and Care Professions Council s standards of proficiency
More informationReflection paper on co-development of pharmacogenomic biomarkers and Assays in the context of drug development
1 2 3 24 June 2010 EMA/CHMP/641298/2008 Committee for Medicinal Products for Human Use (CHMP) 4 5 6 7 Reflection paper on co-development of pharmacogenomic biomarkers and Assays in the context of drug
More informationMedical Devices. LATVIA LAWIN Klavins & Slaidins
Medical Devices LATVIA LAWIN Klavins & Slaidins CONTACT INFORMATION Sarmis Spilbergs LAWIN Klavins & Slaidins Elizabetes 15, Riga, LV 1010, Latvia +371 67814848 sarmis.spilbergs@lawin.lv www.lawin.com
More informationCourse Title ID Duration Basic Premium. Biological Evaluation of Medical Devices: A Risk-Based Approach N mins
Pre-Clinical Basic Level : CMDA Certified Medical Device Associate Biological Evaluation of Medical Devices: A Risk-Based Approach N134 63 mins 186.00 144.00 Introduction to Process Validation N135 75
More information