Implications of the new MDR from a Product Testing and Certification - - PowerPoint PPT Presentation

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Implications of the new MDR from a Product Testing and Certification - - PowerPoint PPT Presentation

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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 from Certification Perspective

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1 www.test-medical-devices.com

Implications of the new MDR from a Product Testing and Certification Perspective

Helping You to Access Global Markets – FAST and PREDICTABLY

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Hans Gerd Evering

www.test-medical-devices.com 2

MDR - Implications from Certification Perspective

Hans Gerd Evering Medical Devices Certification Manager & Product Expert BSI Group Deutschland GmbH

T: +49 69 2222 8 9259 F: +49 69 2222 8 9300 Hans-Gerd.Evering@bsigroup.com

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Certification under the new MDR

  • 1. Check Definition of Medical Device

Article 2

  • 2. Determine “Device Class”

Article 41, Annex VII

  • 3. Select “Conformity Assessment Procedure”

Article 42

  • 4. Identify Applicable “Safety and Performance Requirements”

Article 4, Annex I

  • 5. Assemble “Technical Documentation”

Annex II

  • 6. Apply Conformity Assessment Procedure

Annexes VIII, IX, X, XI

  • 7. Complete “Declaration of Conformity”

Article 17, Annex III

  • 8. Affix “CE Mark”

Article 18, Annex IV

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Rules and Classifications – Annex VII

 21 rules, 1-4 non-invasive, 5-8 invasive, 9-12 active, 13-23 special (18&20 deleted)  Known classes: custom made, Is, Im, IIa, IIb, III  New categories / new requirements:

  • Class III custom-made implantable devices, class Ir (reusable), class IIb (implants),

class IIb (active), class III (implants)  With increased device classification increased involvement of different parties is required:

  • Self-certification
  • Notified Body Conformity Assessment
  • Competent Authority Assessment
  • Commission Assessment - New

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Conformity Assessment Routes – Article 42

 Custom made devices – No principle change

Annex XI (Procedure) in combination with Annex XIII (PMS / PMCF / Incidents)

 Custom made devices which are Class III implants – New

Annex XI in combination with either Annex VIII (QMS) or Annex X – Part A (Production QA)

 Class I devices (none s / m / r) – No principle change

Annex II (Technical Documentation)

 Class I(s), I(m), I(r) devices - New I(r) for reusable devices

Annex II (Technical Documentation) in combination with either Annex VIII (QMS) or Annex X – Part A (Production QA)

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Conformity Assessment Routes – Article 42

 Class IIa devices – No principle change

Annex II (TD for each category) in combination with Annex VIII (QMS) or Annex II in combination either with Annex X – part A (Production QA) or Annex X – part B (Product Verification)

 Class IIb devices – No principle change

Annex II (TD for each category) in combination with Annex VIII (QMS) or Annex IX (Type Examination) in combination either with Annex X – part A (Production QA) or Annex X – part B (Product Verification)

 Class IIb implantable devices – new with the exception of:

sutures, staples, dental fillings & braces, tooth crowns, wedges, plates, pins, clips & connectors Annex VIII (Technical Documentation) in combination with Annex VIII (QMS) or Annex IX (Type Examination) in combination either with Annex X – part A (Production QA) or Annex X – part B (Product Verification)

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Conformity Assessment Routes – Article 42

 Class III devices – No principle change

Including those with medicinal substances, human tissues or animal tissues Annex VIII (Technical Documentation) in combination with Annex VIII (QMS) or Annex IX (Type Examination) in combination either with Annex X – part A (Production QA) or Annex X – part B (Product Verification) Consultation - 2001/83/EC, EC/726/2004, 2004/23/EC, EU/722/2012

 Class III implantable & Class IIb Active Devices intended to administer medicinal products

Annex VIII (Technical Documentation) in combination with Annex VIII (QMS) or Annex IX (Type Examination) in combination either with Annex X – part A (Production QA) or Annex X – part B (Product Verification) Consultation - 2001/83/EC, EC/726/2004, 2004/23/EC, EU/722/2012 Consultation Procedure – Annex VIII or Annex IX Section 6 - New

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Requirements to be met by Notified Bodies – Annex VI

 Certificate Requirements to be shown on QMS and Technical Documentation Certificates – Annex XII

  • From IIa devices upwards the definition of the “Indented Use”
  • Device, Classification, Intended Use, new UDI-DI (Annex V)

 Re-designation Process for NB

  • Early part of second half of 2017
  • Schedule to be seen at the end of this presentation

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Clinical Evaluation – Annex XIII

 Article 2 defines Scope and Definitions

  • Clinical Data, Clinical Evaluation and Clinical Evidence

 Annex XIII - Part A: Clinical Evaluation

  • Definition of similar devices / not clinically significant different
  • Equivalence based on proper scientific justification
  • Sufficient level of access to the data from devices to which equivalence is claimed.

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Clinical Investigations – Annex XIV

 Clinical Evaluation and Investigation – Article 49

Potentially no clinical investigation for implantable devices & class III when:

  • Devices which have been placed onto the market under current directives and for which clinical evaluation is

based on sufficient clinical data and in compliance with common specifications, where available.

  • Devices modified by the same manufacturer who placed the device legally on the market
  • Devices for which demonstration of equivalence is endorsed by NB (Annex XIII) and clinical evaluation is

sufficient demonstrated

  • Devices falling under sutures, staples, dental fillings, etc.

where compliance with the relevant product specific common specification is confirmed

  • Devices for which two manufacturers have a contract in place allowing full access to their technical

documentation

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Post Market Surveillance – PMS / PMCF – Annex XIII

 Article 60 C - Periodic Safety Update Report (IIa, IIb and III devices)

  • Manufacturer to prepare the PSUP (annual or biannual updates)
  • Manufacturer to submit reports to NB’s
  • Depending on device classification NB will evaluate the report and submit to Competent Authorities through the

EUDAMED electronic system (next slide)

  • Article 26 – Summary of Safety and Clinical Performance (III implantable devices)
  • Manufacturer to prepare the SSCP (annual update)
  • To be made public via EUDAMED
  • Drafted version to be submitted to NB

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EUDAMED – Article 27

 Electronic System for Manufacturer Registration - SRN  Electronic System for UDI  Electronic System on Vigilance + Periodic Safety Update Report - PSUR  Applications + Summary of Safety and Clinical Performance – SSCP

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Technical Documentation – Annex II

 Device description, Specifications + UDI, Variants & Accessories  Reference to previous / similar generations of the device  Information supplied by the manufacturer  Design and manufacturing information  General Safety and Performance Requirements (todays ER’s)  Risk/Benefit Analysis and Risk Management  Product Verification / Validation  Pre-clinical and Clinical Data  Additional information in specific cases

Medicinal substances, tissues of human or animal origin, substances that are absorbed, sterile, measuring function, configuration of devices

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UDI – Unique Device Identification – Article 24

 To be placed on individual and higher package systems (not on shipping containers)  The UDI shall be used for reporting incidents and FSCA – Article 61  The UDI shall appear on the D of C – Article 17  The manufacturer shall have a up-to-date list for applied UDI’s in his TF  SPR# 19.2 Information on the label

  • (h) the UDI carrier according to article 24 and Annex V, part C

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Transition Timelines (Article 94 of draft dated June 2016)

Q4 2016*

Adoption of MDR Entry into Force (EUOJ)

(Q1 2017*)

NBs designation under MDR, e.g. BSI

Date of Application

(Q1 2020*)

Last MDD/AIMD certificates expire

(Q1 2024*)

MDD/AIMD max. period (4 years )

MDD/AIMD certificates (max 5-year expiry from issue/renewal date) MDR certificates

Transition period 3 years

* Dates are « best guess » based on our current understanding on the process/steps to be completed

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HOW TO GET EVIDANCE FOR THE TECHNICAL DOCUMENTATION

Stefan Hofmann

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Stefan Hofmann Team Lead Medical / Head of Laboratory CSA Group Europe GmbH

T: +49 69 509571 500 F: +49 69 509571 999 Info.europe@csagroup.org

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Overview

  • Harmonized Standards and Common Specification
  • Technical documentation & general safety
  • Standard IEC 60601-1 (for medical electrical devices)

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MDR

  • Article 6 Use of Harmonised standards

Reference to the standards listed in the Official Journal

  • Article 7 Common specifications

when adopted by the Commission

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ANNEX I General Safety and Performance Requirements

(I.2) …devices shall conform to safety principles, taking account of the generally acknowledged state of the art.

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ANNEX II Technical Documentation

  • (4c) the harmonised standards or CS applied or other

solutions employed

  • (4d) … offering evidence of conformity with each

harmonised standard, CS or other method employed to demonstrate conformity with the general safety and performance requirements. ….

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IEC 60601 Series

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60601-1 60601- 2-xx 60601- 1-xx

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60601-1

  • Medical electrical equipment — Part 1: General

requirements for basic safety and essential performance

  • Valid for all Medical Electrical Equipment

(Basic Standard)

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60601-1-x

Medical electrical equipment — Part 1-8: General requirements for basic safety and essential performance — Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems … Collaterals add new horizontal aspects

  • IEC 60601-1-2 Electromagnetic compatibility
  • IEC 60601-1-3 Radiation protection in diagnostic X-ray equipment
  • IEC 60601-1-6 Usability
  • IEC 60601-1-8 Alarm systems
  • IEC 60601-1-9 environmentally conscious design
  • IEC 60601-1-10 physiologic closed-loop controllers
  • IEC 60601-1-11 home healthcare environment
  • IEC 60601-1-12 emergency medical services environment

Already incorporated in the basic standard (3rd Ed.) Part -1-1 and -1-4

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60601-2-x

Medical electrical equipment — Part 2-x: Particular requirements for the basic safety and essential performance of … Product specific requirements e.g.:

  • IEC 60601-2-2 high frequency surgical equipment
  • IEC 60601-2-18 Endoscopic equipment
  • IEC 60601-2-22 Laser
  • IEC 80601-2-60 Dental equipment
  • ISO 80601-2-61 Pulse oximeter equipment

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Roadmap 60601 Family

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IEC 60601-1

Medical Electrical Equipment – Part 1: General Requirements for Safety

2nd

1988

+A2

1995

IEC 60601-1 Medical electrical equipment, Part 1: General requirements for basic safety and essential performance

3rd

2005

+A1

2012

+A2

2019

4th

2024

IEC 60601-1

Medical Electrical Equipment …

+A1

1991

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Thank you

Questions?

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27

Contact

www.test-medical-devices.com

Helping You to Access Global Markets – FAST and PREDICTABLY