The European Association Medical devices

Slides:

Advertisements

Similar presentations

11 The European Association Medical devices Notified Bodies VISION on REVISION.

Advertisements

The European Association Medical devices - Notified Bodies - Medical Device Survey 2013 data from 28 NBs.

The European Association of Medical device Notified Bodies

The European Association Medical devices - Notified Bodies

The European Association Medical devices

Medsafe – GMP update / release for supply / communicating quality issues Derek Fitzgerald Manager, Compliance Management 11 July 2013 RACI Pharmaceutical.

The New TNI Laboratory Accreditation Standards Requirements for an Accreditation Body.

Accreditation 1. Purpose of the Module - To create knowledge and understanding on accreditation system - To build capacity of National Governments/ focal.

© Safeguarding public health Implementing Medical Device Regulation and Maintaining Patient Safety Name Nicola Lennard Date October 2011.

GCP compliance for GenISIS  This presentation is intended for clinical staff involved in recruiting patients to the GenISIS (Genetics of Influenza Susceptibility.

11 th International Symposium Loss Prevention and Process Safety Promotion in the Process Industries 1 OECD Workshop on Sharing Experience in the Training.

European Commission Enterprise and Industry Market surveillance and automotive type-approval legislation - 28/06/2012 | ‹#› WP.29 Enforcement Working Group.

EUDAMED – general purpose

Overview of Medical Devices Sector Saudi Food and Drug Authority (Saudi Arabia) Dr. Saleh Al Tayyar Director General Medical Devices Sector Saudi Food.

Erik Hansson DG Health and Consumer Protection (DG SANCO) European Commission Developments on product safety in the EU.

© Obelis s.a CODE OF CONDUCT of Authorised Representative services under the Council Directive 93/42/EEC, Directive 98/79/EC and Council Directive.

Revision of the Medical Device Directives The case of ‘Borderline’ Products used in a self-care context 48th AESGP Annual Meeting Nice, 6-8 June 2012 Laurent.

2008 New York - Member Forum Council for Responsible Jewellery Practices, Ltd. Overview of CRJP.

Cavendish Scott, Inc. 1 Regulatory and Statutory Compliance: It’s Everybody’s Business! Diana Lough Cavendish Scott, Inc.

1 ACCREDITATION – BG situation April 2014, Prague STATE AGENCY STATE AGENCY FOR METROLOGICAL AND TECHNICAL SURVEILLANCE TECHNICAL SURVEILLANCE 1.

SALDA Presentation to the Honourable Portfolio Committee on Health National Health Act Amendment Bill B March 2012.

ENTERPRISE AND INDUSTRY DIRECTORATE GENERAL European Commission 1 PECAs David Eardley DG Enterprise and Industry European Commission Tel: 032 (2)

1 REPUBLIC OF TURKEY PRIME MINISTRY UNDERSECRETARIAT OF FOREIGN TRADE General Directorate of Standardization for Foreign Trade Presented by Selin ÖZŞAHİN.

28th Meeting of the Competent Authorities Matthias Neumann Federal Ministry of Health, Germany Cracow, 27th of October 2011 Central Management Committee:

S tefano S oro European Commission Health and Consumer Protection DG OBLIGATION OF PRODUCERS AND DISTRIBUTORS TO NOTIFY DANGEROUS PRODUCTS.

Company Confidential Registration Management Committee RMC Auditor Workshop Charleston, SC July Supplemental Oversight AS9104/2A & Special.

Deregulation to the Economy and removal of Administrative Barriers, Russian Federation EuropAid/114008/C/SV/RU Setting up of national accreditation system.

Directorate General for Enterprise and Industry European Commission The New Legislative Framework - Market Surveillance UNECE “MARS” Group meeting Bratislava,

TAFE NSW -Technical and Further Education Commission BACHELOR OF EARLY CHILDHOOD EDUCATION AND CARE ECEYE208A – Manage a Service.

Proposal for a Regulation of the European Parliament and of the Council on medical devices and amending Directive 2001/83/EC, Regulation (EC) No 178/2002.

UPCOMING CHANGES TO IN-VITRO DIAGNOSTICS (IVDs) AND LABORATORY DEVELOPED TESTS (LDTs) REGULATIONS Moj Eram, PhD November 5, 2015.

organization – status 2015 – scheme – integrity program – strategy

Notified Body Problem Solving Warsaw, Poland 24/26 June 2004 Presented by Peter Hanmore For the benefit of business and people TAIEX Workshop on the Pressure.

TAIEX GPSD Free Movement and Safety Vitomir Fister Beograd,

CLAUDIA PANAIT TAIEX Expert – European Commission Legal Adviser Ministry of Health, ROMANIA.

THE OFFICE FOR REGISTRATION OF MEDICINAL PRODUCTS, MEDICAL DEVICES AND BIOCIDAL PRODUCTS Responsibility in the handling of medical devices.

Harmonised use of accreditation for assessing the competence of various Conformity Assessment Bodies Dr Andreas Steinhorst, EA ERA workshop 13 April 2016,

WORKSHOP ON ACCREDITATION OF BODIES CERTIFYING MEDICAL DEVICES INT MARKET TOPIC 6 CH 5 ISO MANAGEMENT RESPONSIBILITY Philippe Bauwin Medical.

Montenegro Negotiating Team for the Accession of Montenegro to the European Union Working Group for Chapter 6 – Company Law Bilateral screening: Chapter.

Workshop on conformity assessment procedures and certification of medical devices INT MARKT Kyiv, November 2011 Conformity assessment of medical.

Final Rule Accredited Third-Party Certification 1.

Responsibilities of Sponsor, Investigator and Monitor

Health and Consumers Health and Consumers Introduction to the new Medical Device Regulations and their impact on medical software DG for Internal Market,

Clusters working group COM/CAMD New Regulations

Contingent Workforce: Cerner Quality System & Regulations

Update on EU regulatory developments

Industry Implementation Priorities & Challenges COM/CAMD Stakeholders meeting on the new MD and IVD Regulations 9 March, 2017 John Brennan Director.

Flowchart on overview of requirements

Pat Nestor MSCSI MRICS Head of Building Control Dublin City Council

Responsibilities of Sponsor, Investigator and Monitor

Irena Prat and Josée Hansen World Health Organization

Nicole Denjoy COCIR Secretary General

The New Legislative Framework Miniseminar New Legal Framework Reykjavík, 10 December 2008 Doris Gradenegger Unit C1: Regulatory Approach for the Free.

External Validation of Quality Programs

The European Association of Medical device Notified Bodies

Michel BRENON IEC ExTAG Secretary

New European Medical Device Regulations – major changes that will affect all devices Rene van de Zande EMERGO | President & CEO

April 12, 2017 Guy Reese, Program Integrity Manager

Proposal for a Regulation on medical devices and Proposal for a Regulation on in vitro diagnostic medical devices Key Provisions and GIRP Assessment.

“Association Presentation

Quality and Regulatory Planning – the way forward?

NEW MDR Regulatory Context. NEW MDR Regulatory Context.

ACCREDITATION PROCESS

The European Association Medical devices

The European Association Medical devices

External Validation of Quality Programs

2.1. Monitoring of products placed on the market To verify the products comply with applicable directives EC declaration of conformity and technical.

EUnetHTA Assembly May 2018.

General principles of the New Approach legislation

Presentation transcript:

The European Association Medical devices Notified Bodies 2016 Presentation

TEAM-NB Communication with Promote technical and ethical standards Aims: Communication with European Commission Competent Authorities Industry Promote technical and ethical standards Participate in improving the legal framework Contribute to harmonization Represent Notified Bodies 2016 Presentation

TEAM-NB Code of Conduct mandatory 2016 Presentation

Context of TEAM-NB Commission TEAM-NB representatives CEN CENELEC EMA NBRG NB-MED MDEG NBOG COEN Experts Groups EUDAMED, IVD, Vigilance logo I M D R F A Switzerland Canada Australia New Zealand USA Japan, … CPME EUROMContact, EUCOMED, MedTech, FIDES, EDMA, EUROM UEAPME, Eur Assoc of Auth Repr CMC Health Professionals Notified Bodies Manufacturers 28 Competent Authorities National Accreditation Bodies Authorised Representatives Accreditation Notification 2016 Presentation

EUDAMED European Databank on Medical Devices Electronic system on (as proposed by the European Commission) Electronic system on Registration Medical devices / IVDs economic operators, incl. Summary of Safety and Clinical Performance (high risk devices) Electronic system on UDI Device Identifier data elements Electronic system on Certificates Certificates issued by notified bodies & Information on certificates refused suspended reinstated restricted withdrawn Electronic system on Vigilance Serious incidents & Field safety corrective actions Field safety notices Electronic system on Market surveillance Measures taken by Member States re. devices presenting a risk to health & safety preventive health protection measures Electronic system on Clinical investigations Sponsors (& manufacturers) description of: investigational device, comparator, purpose of CI, status of CI NBs need to be able to verify correctiness of economic operators registrations NBs need to be able to access all UDI data relevant to products they assess NBs need to be able to add their own data and review data on their certificate holders NBs need to be able to review vigilance investigations on products they certify NBs need to be able to provide or review periodic safety update reports (PSUR) NBs need to be able to verify all data on studies relating products they certify or are assessing 5 2016 Presentation

Code of Conduct V 3.4 Mandatory to sign for TEAM-NB members Available on website www.team-nb.org New version includes: Peer assessment Unannounced Visits Details on Code of Conduct Compliance Audits by TEAM-NB auditors Version 3.4 in vote for adoption : raising qualification levels 2016 Presentation

Code of Conduct : detailed content Implementation, enforcement and monitoring of the Code of Conduct Unannounced visits Qualification and Assignment of NB Assessment Personnel Minimum time for Notified Body assessments Sampling of class IIa and IIb technical files Design Dossier Reviews Rules for subcontracting Rules for Certification Decisions 2016 Presentation

Contacts www.team-nb.org Management: Guy Buijzen (guy.buijzen@dekra.com) – president ad interim Hans Heiner Junker (hans-heiner.junker@tuev-sued.de) – vice president Alexey Shiryaev (Alexey.Shiryaev@presafe.com) - treasurer Corinne Delorme (corinne.delorme@lne.fr) – secretary Kevin Butcher (kevin.butcher@sgs.com) – CoC board president Françoise Schlemmer (schlemmer@quasys.com) -Director and Secretariat www.team-nb.org 2016 Presentation

Members 2016 Presentation