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26 th September / V. Fischer / Rev. 01 Medical Devices, New Regulations and Standards ASQ Tappan Zee Section

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Page 1: ASQ Tappan Zee Section · ISO 13485:2016 ASQ Tappan Zee Section: Medical Devices, New Regulations/ Standards (Rev 1) Regulation and Standards ... 4 3 2 D&D Changes and Files Control

� 26th September / V. Fischer / Rev. 01

Medical Devices, New Regulations and Standards

ASQ Tappan Zee Section

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Agenda

ASQ Tappan Zee Section: Medical Devices, New Regulations/ Standards (Rev 1)

• Medical Device, General Aspects� Examples � Quality System(s)

• New Regulations & Standards� ISO 13485: 2016� New Medical Device Regulation (EU)

• Questions & Answers

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Presenter

� Current Position� Bayer, Corporate Quality, Quality Audits & Inspections

� Sr. Audit Manager for Medical Device and Packaging Materials.

� Background / Experience� Sr. Manager Supplier Quality, Bayer Medical Care.� Head of Validation Pharmaceutical and Medical Device companies (Switzerland).� Certified QSC ISO 9001 & ISO 13485 Lead Auditor with track record of more then

90 audits.� Consultant for Validation (Switzerland).� Professional background: Dipl. Ing. (B.Sc.) Pharmaceutical Technology, Germany. � Innovation Coach (SIT).

� Private Life� Dive Master (SSI) – 250 logged dives & depth record 176ft.� Travelling around the world and searching good dive places.

ASQ Tappan Zee Section: Medical Devices, New Regulations/ Standards (Rev 1)

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� Definition � Examples� Classification� Quality Systems

ASQ Tappan Zee Section: Medical Devices, New Regulations/ Standards (Rev 1)

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Definition Medical Device acc. to MDR

� 'medical device' means any instrument, apparatus, appliance, software, implant, reagent, material […] for human beings for one or more of the following purposes:

• diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease,

• diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability,

• investigation, replacement or modification of the anatomy or of a physiological or pathological process or state,

• providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations,

� and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means.

Reference: MDR

ASQ Tappan Zee Section: Medical Devices, New Regulations/ Standards (Rev 1)

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Following products are also medical devices: • devices for the control or support of conception; • products specifically intended for the cleaning, disinfection or

sterilization of devices as referred to in Article 1(4) […].

Accessory� 'accessory for a medical device' means an article which,

whilst not being itself a medical device, is intended by its manufacturer to be used together with one or several particular medical device(s) to specifically enable the medical device(s) to be used in accordance with its/their intended purpose(s) or to specifically and directly assist the medical functionality of the medical device(s) in terms of its/their intended purpose(s);

ASQ Tappan Zee Section: Medical Devices, New Regulations/ Standards (Rev 1)

Definition Medical Device acc. to MDR

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Examples of Medical Devices

ASQ Tappan Zee Section: Medical Devices, New Regulations/ Standards (Rev 1)

Intra Uterine Device, class III MD

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� Classification acc. to risk and purpose:

� Criteria for differentiation are e.g :

�Time of application (until 60 min. / until 30 days, longer 30 days).

�Ability of invasion.

�Active device.

�Application to central circulation or nervous system.

�Usage of biological material / animal origin.

Classification

ASQ Tappan Zee Section: Medical Devices, New Regulations/ Standards (Rev 1)

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Class I MD (Bandages, hand held dental instrument, eye glasses)

Simple design, little or no risk. Must follow FDA policy (registration, branding / labeling, manufacturing) and FDA must be notified prior to marketing.

Class II MD (X-ray machines, needles, infusion systems)

More complex design, low- moderate risk. Must follow FDA policy, special labeling, performance standards and post market surveillance. Most MD fall into the Class II category.

Class III MD (implanted devices e.g. stents, hips)

Complex design with high risk. Same requirements as Class I and Class II but with pre-market approval by FDA and scientific review.

Medical Device classes (FDA)

ASQ Tappan Zee Section: Medical Devices, New Regulations/ Standards (Rev 1)

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� ISO Quality Management System – Requirements forregulatory purpose

� FDA 21 CFR 820 – Quality System Regulation

ASQ Tappan Zee Section: Medical Devices, New Regulations/ Standards (Rev 1)

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ASQ Tappan Zee Section: Medical Devices, New Regulations/ Standards (Rev 1)

Quality Management System Approach (acc. to ISO)

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ASQ Tappan Zee Section: Medical Devices, New Regulations/ Standards (Rev 1)

Quality Management System (acc. to FDA QSR)

Corrective & Preventive

Action

Medical Device Tracking

Production & Process Control

Material ControlDesign Control

Reports of Corrections/

RemovalMedical Device

Reporting

Facility & Equipment

Controls

Records/ Documents/

Change Control

Sterilization Process Controls

ManagementMaterial Control

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Pharmaceutical Quality System acc. to ICH Q10

ASQ Tappan Zee Section: Medical Devices, New Regulations/ Standards (Rev 1)

Reference: Annex 2, ICH Q10

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QMS Basic Elements Quality Management System

ASQ Tappan Zee Section: Medical Devices, New Regulations/ Standards (Rev 1)

Quality

Planning

Quality

Assurance

Quality Control

Quality Improvement

Alignment with

Regulations

A Framework

Defines Expectations

& Deliverables

Design Controls +

Risk Management

A QMS is based on: Results in:

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SUMMARY

Quality Management System

ASQ Tappan Zee Section: Medical Devices, New Regulations/ Standards (Rev 1)

Customer Satisfaction Is Key

Change Is Inevitable –

Feedback System

Change Is Inevitable –

Feedback System

Evaluate Progress–Monitoring

Evaluate Progress–Monitoring

Cont. QMS improvement

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New ISO 13485:2016 (Details)

ASQ Tappan Zee Section: Medical Devices, New Regulations/ Standards (Rev 1)

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� Effective since March 01st 2016.

� Three (3) year transition phase.

� Global alignment while allowing organizations to be involved in different stages of the product life-cycle.

� More emphasis on a risk-based approach.

� Emphasis understanding of and adherence to international regulatory requirements (term “regulatory” appears 72 times as previously 16 times).

� New definitions: Clinical evaluation, complaint, distributor, importer,

lifecycle, manufacturer, performance evaluation, postmarket surveillance, purchased product, risk, risk management and sterile barrier system;

Regulation and Standards

New ISO 13485:2016

ASQ Tappan Zee Section: Medical Devices, New Regulations/ Standards (Rev 1)

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Regulation & StandardsISO 13485:2016

ASQ Tappan Zee Section: Medical Devices, New Regulations/ Standards (Rev 1)

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Regulation and StandardsSection 4: General Requirements

ASQ Tappan Zee Section: Medical Devices, New Regulations/ Standards (Rev 1)

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Resp. Authority: documented, incl.

interrelation of personnel affecting

quality and liaison with ext. parties and reg.

authorities.

Management Review: Rationale must be

documented for the frequency of

management reviews.

Review input and output requirements have been added to maintain the

suitability and adequacy of the QMS.

Regulation and StandardsSection 5: Management Responsibility

ASQ Tappan Zee Section: Medical Devices, New Regulations/ Standards (Rev 1)

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Regulation and Standards

Section 6: Resource Management

ASQ Tappan Zee Section: Medical Devices, New Regulations/ Standards (Rev 1)

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Regulation & StandardsSection 7: Planning of Product Realization

ASQ Tappan Zee Section: Medical Devices, New Regulations/ Standards (Rev 1)

1

6

5

4

3

2

Planning of Product Realization

Requirement how risk mgt. activities should be handled for product handling.

Documented risk mgt. throughout development-planning activities.

Product Requirements

Determination need for user training to ensure specified performance / safe use of a product. Ensure appl. regulatory requirements are met (product review requirements)

Communication with Reg. Authorities:

Documented arrangements for communicating with regulatory authorities regarding: product information, regulatory inquiries, complaints, and advisory notices.

Design & Development Transfer

New: documented plan for design:� Plans for supplier quality and capability, manufacturing personnel capability and training, manufacturing process and process validation etc.

D&D Verification/ Validation

Validation on final production builds; Verification/ validation of user instructions Review of failure modes;

Design & Development Planning

Update doc’s with D&D progress; Traceability of outputs/ inputs in documentation;Inputs: Include usability and verification/ validation; Outputs: Suitable form for verification; Competence of personnel in D&D activities defined and demonstrated; Independent reviewer required

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Regulation & StandardsSection 7: Planning of Product Realization (cont.)

ASQ Tappan Zee Section: Medical Devices, New Regulations/ Standards (Rev 1)

1

6

5

4

3

2

D&D Changes and Files

Control changes, documentation to be kept, approval, reports/ testing to justify changes etc.

D&D files must be maintained per MD type/ family; Demonstrate conformity to requirements

Supplier Documentation

Processes for supplier approvals and monitoring continue compliance. Justifications for selecting suppliers, incl. criteria for evaluation/ reevaluation

Purchasing Information

Quality agreements requiredNotification of changesVerification of processes

Requirements for Sterile MDs

Cleanliness requirements whether sterilization process.Document cleanliness for products cannot be cleaned prior to sterilization (or significant factor in the device’s use);Add. measures to ensure sterility

Identification & Traceability

If UDI is required manufacturer needs to establish and maintain a UDI;

Validation of Production & Service Provision

Requirement to include procedures for validation of sterilization and packaging; Statistical techniques applied and rationale for sample sizes;

Shipping conditions and impact on product/ package integrity, incl. sterile device packaging, must be assessed.

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Regulation and StandardsSection 8: Measurement, analysis and improvement

ASQ Tappan Zee Section: Medical Devices, New Regulations/ Standards (Rev 1)

Measurement Analysis &

Improvement

Feedback

Complaint Reporting

•Procedures for timely complaint handling/ investigation as well as managing regulatory notifications/ reporting.

Monitoring and Measurement

•Records must identify equipment used and person(s) authorizing release of the product.

Nonconforming Product

•Evaluation to include a determination of the need to investigate, or justification for lack of investigation.

•Requirements before product delivery, after delivery, and rework.

CAPA/ Rework

•Actions do not adversely affect reg. req./ safety/ performance. •Corrective action plans commensurate with risk.

•Analyze impact to QMS/ Regulatory reqs. before finalization.

•Incl. product / process data review; Linked to product risk Mgmt..

• Procedures, input to risk management and statistical analysis must be considered.

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� New Medical Device Regulation (Europe)

ASQ Tappan Zee Section: Medical Devices, New Regulations/ Standards (Rev 1)

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Background

New Medical Device Regulation (EU)

� Issued in 2017 (May 25th).

� Active Implantable Medical Device Directive (AIMD) and Medical Device Directive (MDD) replaced by EU Medical Device Regulation (MDR).

� In Vitro Diagnostic Device Directive (IVDD) replace by EU in In Vitro Diagnostics Regulation (IVDR).

� Three (3) year transition period for MDR and five (5) year transition period for IVDR.

� The first changes will apply to the Notified Bodies, 2018

� The last changes will apply to devices in the distribution chain, 2024.

ASQ Tappan Zee Section: Medical Devices, New Regulations/ Standards (Rev 1)

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� Identification of “qualified person” - who is ultimately responsible for all aspects of compliance to the new MDR. Must document the specific qualifications of this individual relative to the required tasks.

� No "grandfathering" provisions .

� Systematic clinical evaluation of Class IIa and Class IIbmedical devices .

� More rigorous clinical evidence for class III and implantable medical devices .

� Reclassification of devices according to risk, contact duration and invasiveness.

ASQ Tappan Zee Section: Medical Devices, New Regulations/ Standards (Rev 1)

New Medical Device Regulation (EU)

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� Rigorous post-market oversight

� Implementation of unique device identification

� Product scope expansion

ASQ Tappan Zee Section: Medical Devices, New Regulations/ Standards (Rev 1)

New Medical Device Regulation (EU)

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� Confirm it is a MD or In Vitro Diagnostic� Determine Classification

� Identify Conformity Assessment Procedure

� Address General Safety and Performance Requirements

� Prepare Technical Documentation

� Complete Conformity Assessment� Sign Declaration of Conformity� Affix CE Marking� Conduct Post Market Surveillance and

Vigilance

New MDR

High-level MDR/ IVDR CE Marking Process

ASQ Tappan Zee Section: Medical Devices, New Regulations/ Standards (Rev 1)

� Article 2

� MDR Art. 51, IVDR Art. 47, Annex VIII

� MDR Art. 52, IVDR Art. 48

� Art. 5, Annex I,

� Art. 10, Annex II and III

� Annexes VIII, IX, X, XI

� Art. 19, Annex IV

� Art. 20, Annex V

� Art. 83, 87 MDR Annex XIV, IVDR Annex XIII

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Transition MDD to MDR

New MDR

ASQ Tappan Zee Section: Medical Devices, New Regulations/ Standards (Rev 1)

Notification according to MDD is no longer validCan issue certificates according to current MDD

Still able to manufacture, import, distribute & use Only for distribution and use

201920182017 20212020 2022+

Notified Bodyaccording to MDD

Device conformsto current MDD

Device conformsto new MDR

Notified Bodyaccording to MDR

Cannot be used

EU portal forregistration etc.

UDI required in technical and registration data only UDI on labels

Existing national registrations remain in place EU portal in useEU portal for HA’s only

Unique DeviceIdentification (UDI)

TRANSITION

Notified Bodies can issue certificates according to the new MDR

Devices can be placed on the EU market. i.e. able to manufacture, import, distribute and use

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Key Impacts

New MDR

Products

• Up Classification(s).

• Out Classification.

• Dossier upgrade(s).

• Potential need for additional data (non-clinical / clinical).

Processes

• Notifications to EU database (EUDAMED).

• UDI (Unique Device Identifier) labeling and notifications.

• Increase tracebility on «economic operators» (update / creation of newcontracts between Legal Manufacturers and Supply Chain actors).

• Increased Post-Market Surveillance , Vigilance, Clinical requirements.

ASQ Tappan Zee Section: Medical Devices, New Regulations/ Standards (Rev 1)

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New MDR

ASQ Tappan Zee Section: Medical Devices, New Regulations/ Standards (Rev 1)

US Regulator System EU Regulator System

QSR 21 CFR Part 820 ISO 13485 + MDR/ IVDR (MDSAP)

Inspection by FDA Assessment by Notified Body (depending on classification)

PMA Technical Documentation

Or - Sampled by NB

510K - General Safety and Performance Req.

- Risk Assessment

Reviewed by FDA - Clinical Evaluation/ Performance Evaluation

Manufacturers Declaration of Conformity

FDA US Market Clearance CE Mark

Medical Device Reporting (MDR)

Manufacturer postmarket req. (incl. complaints and vigilance, PMCF, PMPF, PSUR etc.

FDA Inspections (24 month) NB QMS Audits (annually)

NB QMS / Device Recertification every 5 years.

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� Has a precise scope of actions and responsibilities in the framework of the EU MD regulation.

� Independent certification organization that is “notified” by a EU Member State’s Competent Authority to determine if a product or system meets applicable requirements for CE marking.

� Evaluates the conformity of products and the associated quality systems for manufacturers .

� Reduction of NB from 80 to 60 due to more stringent requirements.

Role of a Notified Body

ASQ Tappan Zee Section: Medical Devices, New Regulations/ Standards (Rev 1)

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ASQ Tappan Zee Section: Medical Devices, New Regulations/ Standards (Rev 1)

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ASQ Tappan Zee Section: Medical Devices, New Regulations/ Standards (Rev 1)