Technical documentation. Capita Selecta proposed MDR
|
|
- Ethelbert Collins
- 6 years ago
- Views:
Transcription
1 Technical documentation Capita Selecta proposed MDR
2 Technical Documentation MDD / AIMDD (In daily practice) technical documentation = design dossier = technical (construction) file = design history file Summary TEchnical Documentation (STED) Based on former GHTF guidance, now IDMRF documentation International Medical Device Regulators Forum Richtlijn Medische Hulpmiddelen 2
3 MDD / AIMDD Technical documentation Contents of Technical dossier defined in: MDD 93/42/EEC: Annex II.3.2(c) (design of the product Design dossier) Annex III.3 (technical documentation) Annex VII.3 (technical documentation) AIMD 90/385/EEC: Annex 2.3.2(c) (Design of the product Design dossier) Annex 3.3 (technical documentation) 3
4 Proposal MDR one location Annex II Technical documentation (STED?) 1. Device description specification variants accessories 2. Information to be supplied by manufacturer 3. Design and manufacturing information 4. General safety and performance requirements 5. Risk / Benefit analysis and risk management 6. Product verification and validation Annex III EU Declaration of conformity 4
5 Proposal MDR Article 7: CTS to be developed to address technical documentation requirements. Article 8: Manufacturer obligation to draw up technical documentation. Article 9: Authorized Representative: Keep the technical documentation available for 5/15 years (!!!). 5
6 Proposal MDR Article 11: Importer Ensure that technical documentation is drawn up by manufacturer (HOW??). Ensure that the technical documentation is available for 5 / 15 years (HOW??). Article 13: Qualified Person: responsible to ensure TD is drawn up and kept up-to-date. new Liability issue on personal level??? Article 24: Unique Device Identifier: must be included in the TD. 6
7 Article 42 conformity assessment procedures Class III: Annex II Annex VIII (Full QA and DD) Or: Annex IX (Type Examination) and Annex X (prod conf verif.) Annex III + V Class IIb: Annex VIII, except Chapter II (Full QA) with: Annex II.3 assessment of the design documentation within the technical documentation on a representative basis Annex II section 3 only? Or: Annex IX (Type Examination) and Annex X (prod conf verif.) Annex III + V 7
8 Article 42 conformity assessment procedures Class IIa: Annex II.3 Annex VIII, except Chapter II (Full QA) with: assessment of the design documentation within the technical documentation on a representative basis Annex II section 3 only? Or: Technical documentation conform Annex II coupled with: Annex X (prod conf verif.) Section 7 Part A (production QA) or Section 8 part B (Product verification) Annex VII+V/VI 8
9 Article 42 conformity assessment procedures Class I Self declaration on Annex II conform Article 17 (DoC) Class Isterile / Imeasure: Annex VIII, except Chapter II (Full QA): Or: Annex X Part A But: NB assessment only on: Securing / maintaining sterile conditions Conformity with metrological requirements Annex II.3 Annex V 9
10 MDR Article 49: Clinical evaluation: The adequacy of demonstration of conformity with the general safety and performance requirements based on the results of nonclinical testing methods alone, including performance evaluation, bench testing and pre-clinical evaluation, has to be duly substantiated in the technical documentation referred to in Annex II. The clinical evaluation and its outcome shall be documented in a clinical evaluation report referred to in Section 6 of Part A of Annex XIII which shall be included or fully referenced in the technical documentation referred to in Annex II relating to the device concerned. 10
11 MDR Article 65: vigilance data: Actively update the TD with this information make available to Notified Bodies. Annex I GSPR 7.5: Phthalate justification needs to be in TD in case device is used for treatment of children or treatment of pregnant or nursing women. 11
12 Annex II Technical documentation 1. Device description and specification including variants and accessories. STED requirements. But with an EU touch: - UDI - Risk class and rule + justification / argumentation - Explanation of novel features (??? Novel to what?) - Overview previous generations and market experience. 12
13 Annex II Technical documentation 2. Information supplied by the manufacturer - IFU - Labels (on device and on packaging) New: List of language variants. 13
14 Annex II Technical documentation 3. Design and manufacturing information (a) Information to allow a general understanding of the design stages applied to the device and the manufacturing processes such as production, assembly, final product testing, and packaging of the finished device. More detailed information needs to be provided for the audit of the quality management system or other applicable conformity assessment procedures; (b) identification of all sites, including suppliers and sub-contractors, where design and manufacturing activities are performed. Remember: Article 42 Class IIa and IIb: Assessment of the design documentation within the technical documentation on a representative basis Is this sufficient? Only general understanding? 14
15 Annex II Technical documentation 4. General Safety and Performance Requirements (GSPR) Essential Requirements Checklist can be used to demonstrate how the GSPR s are met. ER Checklist As before, but now specifically required to be included: Precise identity of the controlled documents offering evidence Cross reference to the location in the TD / STED. 15
16 Annex II Technical documentation 5. Risk / benefit analysis and risk management To address Risk / Benefit as defined in Annex I sect. 1 and 5. To identify solutions adopted + result Risk Management as referred to in Annex I section 2. In short: EN ISO 14971:2012 EN / EN IEC 62366:
17 Annex II Technical documentation 6. Product verification and validation results of verification and validation testing studies undertaken to demonstrate conformity of the device 6.1 Preclinical and clinical data results of (engineering, laboratory, simulated use, animal) tests and evaluation of published literature Biocompatibility Physical, chemical and mechanical characterization Electrical safety and EMC Software verification and validation Stability / shelf life GLP verification 17
18 Annex II Technical documentation Where no new testing has been undertaken, the documentation shall incorporate a rationale for that decision, e.g. biocompatibility testing on the identical materials was conducted when these were incorporated in a previous version of the device that has been legally placed on the market or put into Service. Only identical material comparison? ISO requests more! Maybe better: take risk management approach assessing impact on changes there s your rationale. 18
19 Annex II Technical documentation Also include: The report on the clinical evaluation in accordance with Article 49(5) and Part A of Annex XIII; The PMCF plan and PMCF evaluation report in accordance with Part B of Annex XIII or any justification why a PMCF is not deemed necessary or appropriate. Already now regularly requested by NB s to present PMCF Plan as part of initial submission. Include the results of PMCF activities in the TD. 19
20 Annex II Technical documentation 6.2 Additional information in specific cases. Medicinal product CTS Human / Animal Tissue / cells Sterilization validation reports Measurement function validation Connected to other device evidence of combined use. 20
21 Annex III - DoC Specifically defines minimal requirements to be included on the DoC: Name, Trade name etc AND address Statement: DoC issued under sole responsibility of manufacturer UDI device ID. Product / trade name, code, catalogue # etc. Risk class Conformity to regulation statement Reference to harmonized standards / CTD used. Name of NB and number, conformity route + certificate # Additional information Sign, date, place, indication for and on behalf of whom is signed. 21
22 Annex IV 22
23 Conclusion If you already follow all current MEDDEV s, guidances, etc, If you already have implemented an effective QMS, If information out of the market is already feeding back in your dossier through Post Market Surveillance, Risk management, design control, What will change, really? Nothing! Although (changes in rules classifications, ER s changed). See you next time!! 23
24 We are a flexible and pragmatic team player in your medical device project Medical Device Project B.V. Lupinesingel 556 NL-2403 EB Alphen aan den Rijn The Netherlands M +31 (0) T +31 (0) E robert.van.boxtel@mdproject.nl I 24
MEDICAL 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 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 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 informationEU MDR Deep Dive: GSPRs, Technical Docs, PMS. 19 JUNE 2018 ASQ RAPS MASSMEDIC Waltham Woods
EU MDR Deep Dive: GSPRs, Technical Docs, PMS 19 JUNE 2018 ASQ RAPS MASSMEDIC Waltham Woods Glen Emelock Sr. Partner, The CRO Group Lead Auditor, Technical Expert, NSAI The Fine Print All opinions expressed
More informationImplications of the new MDR from a Product Testing and Certification Perspective
Implications of the new MDR from a Product Testing and Certification Perspective Helping You to Access Global Markets FAST and PREDICTABLY www.test-medical-devices.com 1 Hans Gerd Evering MDR - Implications
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 informationTechnical Documentation
Technical Documentation Helga Seiler M.Sc. Vision Science and Business (Optometry) Manager RA Disclaimer 2 The following list of information is not exhaustive The information and views given in the following
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 informationMDR. Device Classification Conformity Assessment Safety & Performance Requirements Technical Documentation
MDR Device Classification Conformity Assessment Safety & Performance Requirements Technical Documentation Suzanne Halliday, D.Phil. Jaishankar Kutty, Ph.D. Ronald Rakos, Ph.D BSI Roadshow, October 2017
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 informationEU MDR: Tips for Effectively Addressing the New Requirements
Expert advisors. Exact practices. EU MDR: Tips for Effectively Addressing the New Requirements Mary Beth Henderson, Ph.D., MBA September 26, 2018 Thank you for joining us We will begin at 11:00 Central
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 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 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 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 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 informationSummary Technical Documentation STED
Summary Technical Documentation STED Dr Haidong Liang, PhD Clifton Medtech Consulting info@cliftonmedtech.com http://cliftonmedtech.com/ September 2016 Based on Summary Technical Documentation for Demonstrating
More informationTechnical documentation in the new MDR. Gabriele Catignoli, Andreas Purde
Technical documentation in the new MDR Annex I/II Gabriele Catignoli, Andreas Purde TÜV SÜD Product Service GmbH Slide 1 MDR Annex I, II 1 Core changes, Essential Requirements 2 Role of Common Specifications
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 informationGUIDANCE NOTE FOR MANUFACTURERS OF CUSTOM-MADE MEDICAL DEVICES
GUIDANCE NOTE FOR MANUFACTURERS OF CUSTOM-MADE MEDICAL DEVICES Foreword This guidance document is informative and advisory and has no legal authority. Individual national enforcement authorities are bound
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 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 informationChanges to the Medical Devices Directive and affect on Manufacturers
TÜV Product Service Ltd Webinar 18 th November 2009 Changes to the Medical Devices Directive and affect on Manufacturers Henry Sibun Manager, Medical & Health Services UK CONTENTS / 1. Introduction 1.
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 informationMedical Device Regulation
Johner Institut Medical Device Regulation 7 Steps to MDR Compliance Astrid Schulze Graduate in economics 20 years entrepreneur in quality management and approval of medical devices and software Since 2017
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 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 informationGETTING READY FOR THE EUROPEAN UNION (EU) MEDICAL DEVICE REGULATION (MDR)
GETTING READY FOR THE EUROPEAN UNION (EU) MEDICAL DEVICE REGULATION (MDR) Caroline Leab Abbott Director of Regulatory Affairs David Wolf PTC Program Director of Medical Device Strategy liveworx.com NEW
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 informationGUIDANCE NOTES FOR MANUFACTURERS OF CLASS I MEDICAL DEVICES
MDEG - 2007-12 - II-3.3 MSOGClassIGuidance_Final GUIDANCE NOTES FOR MANUFACTURERS OF CLASS I MEDICAL DEVICES Foreword These guidance notes do not aim to be a definite interpretation of National Laws and/or
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 informationPost market Surveillance ISO EU Medical Device Regulation
Post market Surveillance ISO13485 2016 EU Medical Device Regulation Patrick Caines, Ph.D. Baxter Healthcare 15 June 2017 Agenda Post market Regulatory Requirements ISO 13485 2016 Summary of key changes
More informationMed-Info. Directive 98/79/EC on in-vitro diagnostic medical devices. TÜV SÜD Product Service GmbH
Med-Info International expert information for the medical device industry Directive 98/79/EC on in-vitro diagnostic medical devices Practice-oriented summary of the most important aspects and requirements
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 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 DEVICES: Guidance document
EUROPEAN COMMISSION DG ENTERPRISE Directorate G Unit 4 - Pressure Equipment, Medical Devices, Metrology MEDICAL DEVICES: Guidance document MEDDEV 2.12-2 May 2004 GUIDELINES ON POST MARKET CLINICAL FOLLOW-UP
More informationMedical Devices Regulation (MDR) Readiness Review
` Medical Devices Regulation (MDR) Readiness Review Company Name Address Certification No. Date: Contact Name Job Title Telephone Email How ready are you for the Medical Devices Regulation? The MDR, which
More informationPost Market Surveillance (including PMCF): common non compliances
Post Market Surveillance (including PMCF): common non compliances Jayanth Katta Ph.D Product Specialist & Certification Manager, General Devices Team, Healthcare 1 Overview EU PMS Requirements for Medical
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 informationMedical Device Directive
Medical Device Directive WG9 - IEC/SC 62A ISO/TC 184/SC 2 Joint Working Group 9 Saeed Zahedi 4 th of July 2012 Blatchford Copyright 2012 Commercial in confidence Definition and Requirements MDD is law,
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 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 informationGS1 Ireland Healthcare User Group (HUG) Information Day
GS1 Ireland Healthcare User Group (HUG) Information Day Regulatory update Medical Devices and the impact for Irish Healthcare Sinead Duggan, HPRA 28 th March 2017 29/03/2017 2 Medical Devices Regulation
More informationUnderstanding Clinical Equivalence
Understanding Clinical Equivalence BSI 2014 Medical Device Mini-Roadshow Ibim Tariah Ph.D Technical Director, Healthcare Solutions 1 Understanding Clinical Equivalence Review Requirements from Directives
More informationCopyright GCI, LLC Remediation of Legacy Medical Devices
Copyright GCI, LLC. 2016 Remediation of Legacy Medical Devices Copyright GCI, LLC. 2016 What Drives Legacy Remediation? Proactive Recertification / CE Mark Audit Readiness M&A / Due Diligence Reactive
More informationVIGILANZA E SORVEGLIANZA POST- COMMERCIALIZZAZIONE
VIGILANZA E SORVEGLIANZA POST- COMMERCIALIZZAZIONE VIGILANZA E SORVEGLIANZA POST-COMMERCIALIZZAZIONE Post-Market Surveillance dal punto di vista dell O.N in vista dei nuovi Regolamenti (MDR/IVDR) Francesco
More informationPART 1 DEVICE MASTER FILE
Form-No.: 01 03 00 19e Proposal for a General Product Documentation 0.1 Cover page (company, title, No., release, signature etc.) 0.2 Content (e. g. as document master file) 0.3 General information about
More informationISO 13485:2016 Medical Devices-Quality Management Systems- Requirements for Regulatory Purposes. Theresa McCarthy
ISO 13485:2016 Medical Devices-Quality Management Systems- Requirements for Regulatory Purposes Theresa McCarthy Welcome and Introductions Please interview and collect: Name Primary Quality Management
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 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 informationApplication for Examination of a Quality System according to LVFS 2003:11 (for CE marking o medical devices)
Company (applicant): hereby applies to, as Notified Body, in accordance with the EG-directive 93/42/EEC (changed 2007/47/EG) for review according to below Review in accordance with 93/42/EEC Annex Annex
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 informationChecklist for the assessment based on the standards
ISO & MDD & Checklist for the assessment based on the standards ISO :2016 ISO :2016 associate with EC Directive 93/42 EEC Where applicable EC Directive 93/42/EEC Annex II/V/VI Company: Audit date Auditor:
More informationEU MDR 10 Things Packaging Engineers Should Know
EU MDR 10 Things Packaging Engineers Should Know networkpartners.com NUMBER ONE THE TIME FOR ACTION IS NOW First, some background: The EU Medical Device Regulation (MDR) was approved by the European Parliament
More informationGuide for Class I Manufacturers on Compliance with European Communities (Medical Devices) Regulations, 1994
Guide for Class I Manufacturers on Compliance with European Communities (Medical Devices) Regulations, 1994 SUR-G0006-2 27 AUGUST 2010 This guide does not purport to be an interpretation of law and/or
More informationEU MDR Timeline. Dr. Christian B. Fulda Jones Day FDLI Annual Conference Access materials at fdli.org/annual2018
EU MDR Timeline Dr. Christian B. Fulda Jones Day EU MDR - Timeline EU has entered into force, but will only apply for products as of May 26, 2020, with transitional period through 2024/2025? Look closer!
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 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 informationEU Update Proposed Regulations, Own Brand Labelling, Unannounced Audits
EU Update Proposed Regulations, Own Brand Labelling, Unannounced Audits Neil Adams Copyright 2015 BSI. All rights reserved. Overview Commission Regulation: How Competent Authorities control Notified Bodies
More informationClinical Evaluation and Clinical Investigation update MDR
Clinical Evaluation and Clinical Investigation update MDR December 5 th, 2017 Carine Cochereau, Cardinal Health Slide 1 Directives: obligation for Member State (MS) to implement provisions into their national
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 informationExperience with Directive 93/42/EEC (MDD)
(MDD) A medical device manufacturer s retrospective view on 19 years of experience with Directive 93/42/EEC Lübeck, 2012-09-05, Dr. Peter Gebhardt Preliminary Remarks Scope of this presentation is based
More informationSOFTWARE APPS AS MEDICAL DEVICES. The Regulatory Landscape 2015 WHITE PAPER WHITE PAPER PRODUCED BY MAETRICS
WHITE PAPER SOFTWARE APPS AS MEDICAL DEVICES The Regulatory Landscape 2015 WHITE PAPER PRODUCED BY MAETRICS For more information, please contact: USA Office: +1 317 706 1493 UK Office: +44 115 921 6200
More informationWELMEC Application of module D Quality assurance Under directive 2014/32/EU (MID) or directive 2014/31/EU (NAWID)
WELMEC 8.4 2017 Application of module D Quality assurance Under directive 2014/32/EU (MID) or directive 2014/31/EU (NAWID) WELMEC is a cooperation between the legal metrology authorities of the Member
More informationTop Ten CE Marking Issues
Top Ten CE Marking Issues Ibim Tariah Copyright 2015 BSI. All rights reserved. Experience is the name everyone gives to their mistakes -- Oscar Wilde Copyright 2015 BSI. All rights reserved. 2 Learning
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 informationNew European Rules governing medical devices vigilance and combination products. Lincoln Tsang May 2008
New European Rules governing medical devices vigilance and combination products Lincoln Tsang May 2008 Topics Review of rules governing medical devices sector Changes made in the new law New framework
More informationConformity Assessment of Own Brand Labelling
NBRG/306/06 Co-ordination of Title: Chapter: Conformity Assessment of Own Brand Labelling 2.5.5 Conformity assessment for particular product groups Text: Key words: manufacturer means the natural or legal
More informationCRT 2 NEWS. Interpretative Documents from the Commission
CRT 2 NEWS Subject: Interpretative Documents from the Commission 1 Introduction The legal service of the European commission published documents called Interpretative Documents. These documents clarify
More informationCE Marking for Medical devices
CE Marking of Medical Devices Bart Mersseman Head of Notified Body SGS Belgium Thursday Octobere 12 th 2017 Vlaamse dag van de CE-markering CE Marking for Medical devices Prologue: Legislation in Europe
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 informationPerson Responsible. Requirements. for Regulatory. Door Leo Hovestadt
Person Responsible for Regulatory Requirements Door Leo Hovestadt Agenda Oversight Competant Authority Availability MDR BREXIT Notified Body Availability License to sell due dates MDR 2020 UK 2019 Quality
More information8 Steps towards EU-MDR implementation
8 Steps towards EU-MDR implementation Gert Bos Executive director & Partner A global leading medical device consultancy group Europe - Amsterdam (HQ) USA - Boston - San Francisco China Nanjing Copyright
More informationMedical Devices. The technical requirements also apply when the submitter is not the legal manufacturer 1 (i.e: a distribution company).
UNFPA Technical requirements for medical devices 1. Introduction The following document provides UNFPA s technical requirements in the procurement of medical devices (medical equipment, renewable medical
More informationFREQUENTLY ASKED QUESTIONS DURING ELECTRO-MEDICAL DEVICE MARKET ACCESS
FREQUENTLY ASKED QUESTIONS DURING ELECTRO-MEDICAL DEVICE MARKET ACCESS Helping You to Access Global Markets FAST and PREDICTABLY Vishal Thakker, MEng(Hons), AMIMechE Scheme Manager/Product Specialist BSI
More informationQuality System Requirements for Medical Devices Reference Guide for Manufacturers Selling Medical Devices in Europe, Canada and the United States
Quality System Requirements for Medical Devices Reference Guide for Manufacturers Selling Medical Devices in Europe, Canada and the United States 2005 Version For further information, please contact: Life
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 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 informationMapping Your Success Staying Current on Standards Under the EU Approach
Mapping Your Success Staying Current on Standards Under the EU Approach Overview What is a Standard? Why use Standards? EU Harmonized Standards what does it mean? EU Standards Harmonization Process Annex
More informationAAMI Quality Systems White Paper
AAMI s White Paper Comparison of 21 CFR Part 820 to ISO 13485:2016 February 2017, Updated February 2018 AUTHORS Seb Clerkin, GMP Advisory Services Nicola Martin, Owner, Nicola Martin Consulting Jack Ward,
More informationNotified Bodies Recommendation Group
Notified Bodies Recommendation Group Recommendation for the Interpretation and Implementation of the Commission Recommendation on audits and assessments performed by notified bodies in the field of medical
More informationContents. Regulatory Bodies... 13
Contents UNITED STATES... 3 Regulatory Bodies... 3 Product Classification and Regulatory Control... 3 Application Documents... 3 Quality System Requirements... 4 Product and Manufacturer s License... 4
More informationClinical Data Evaluation Lessons Learned
Clinical Data Evaluation Lessons Learned Laurel Macomber MS, PMP, RAC BSI Product Expert, General Devices Presented by Ibim Tariah Ph.D Technical Director - Healthcare Copyright 2015 BSI. All rights reserved.
More informationDocumentation requirements for an initial consultation
Language : French or English Documentation requirements for an initial consultation Because of the wide range of medical devices which incorporate, as an integral part, an ancillary medicinal substance,
More informationMedDev and NB-MED Recommendations
Titel of 2.1 Scope, field of application, explanation of terms Guidelines relating to the application of AIMD and MDD: Definition of medical devices, accessory and manufacturer Guidelines relating to the
More informationMDR Post Market Surveillance
MDR Post Market Surveillance Gert Bos Executive Director & Partner A global leading medical device consultancy group surveillance - SECTION 1 POST-MARKET SURVEILLANCE PMS requires for all products: Post-market
More informationFINAL DOCUMENT. International Medical Device Regulators Forum. Medical Device Regulatory Audit Reports
FINAL DOCUMENT International Medical Device Regulators Forum Title: Authoring Group: Medical Device Regulatory Audit Reports IMDRF MDSAP Working Group Date: 2 October 2015 Toshiyoshi Tominaga, IMDRF Chair
More informationMEDICAL DEVICES : Guidance document
EUROPEAN COMMISSION DG ENTERPRISE Directorate G Unit 4 - Pressure Equipment, Medical Devices, Metrology MEDICAL DEVICES : Guidance document MEDDEV 2. 1/4 March 1994 GUIDELINES RELATING TO THE APPLICATION
More informationUnannounced Visits. Welcome! We will start the webinar presentation at 9am. Copyright 2014 BSI. All rights reserved.
Unannounced Visits Welcome! We will start the webinar presentation at 9am Copyright 2014 BSI. All rights reserved. Unannounced Visits John Howlett Head of Notified Body Vicky Medley Head of QMS Copyright
More informationPart I General information
MD TECHNICAL FILE: INFORMATION TO PROVIDE IN THE FRAME OF AN INITIAL ASSESSMENT Directives 90/385/EEC and 93/42/EEC Annex III: EC Type-Examination Annex II.4: EC Design Examination In the case of an initial
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 informationPRIPREMA KLINIČKE DOKUMENTACIJE ZA MEDICINSKO SREDSTVO U POSTUPKU DOBIJANJA CE ZNAKA. Zoran Spasić, dipl. maš. inž.
PRIPREMA KLINIČKE DOKUMENTACIJE ZA MEDICINSKO SREDSTVO U POSTUPKU DOBIJANJA CE ZNAKA Zoran Spasić, dipl. maš. inž. 2 SADRŽAJ Termini i definicije Regulatorni zahtevi Smernice Praktičan pristup 3 Priprema
More informationGuidelines for conformity assessment of In Vitro Fertilisation (IVF) and Assisted Reproduction Technologies (ART) products
Ref. Ares(2015)2069323-18/05/2015 EUROPEAN COMMISSION DG HEALTH & CONSUMERS Directorate B - Consumer Affairs Unit B2 Health Technology and Cosmetics MEDICAL DEVICES: Guidance document MEDDEV 2.2/4 January
More informationEuropean Medical Device Regulations (MDR): What To Expect
European Medical Device Regulations (MDR): What To Expect MDQC March 2016 Paul Brooks Senior Vice President Healthcare Solutions Copyright 2015 BSI. All rights reserved. Sources for MDR Update Commission
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 information1 Preface Introduction... 13
1 Preface... 11 2 Introduction... 13 3 Legal Requirements... 15 3.1 Approach to determining the legal implications... 15 3.2 Software as a medical device... 17 3.2.1 Intended purpose... 18 3.2.2 Normal
More informationMEDICAL DEVICE GUIDANCE DOCUMENT
MDA/GD-0XX June 2015 First Edition MEDICAL DEVICE GUIDANCE DOCUMENT DECLARATION OF CONFORMITY (DoC) Medical Device Authority MINISTRY OF HEALTH MALAYSIA Contents Preface...iii 1 Introduction...1 2 Purpose...1
More informationThe Medical Device Coordination Group: a new Authority Under EU Device Regulations
The Medical Device Coordination Group: a new Authority Under EU Device Regulations By Robert D. Cumming and Nancy W. Mathewson, Esq. This article discusses the organization and functions of the Medical
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 information