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

Transcription

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

2 Agenda Medical Device, General Aspects Examples Quality System(s) New Regulations & Standards ISO 13485: 2016 New Medical Device Regulation (EU) Questions & Answers

3 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 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.

4 Definition Examples Classification Quality Systems

5 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

6 Definition Medical Device acc. to MDR 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 togetherwith 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);

7 Examples of Medical Devices Intra Uterine Device, class III MD

8 Classification Classification acc. to risk and purpose: Criteria for differentiation are e.g : Time of application(until 60 min. / until 30 days, longer30 days). Ability of invasion. Activedevice. Applicationtocentralcirculationornervoussystem. Usage of biological material / animal origin.

9 Medical Device classes (FDA) 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.

10 ISO Quality Management System Requirements for regulatory purpose FDA 21 CFR 820 Quality System Regulation

11 Quality Management System Approach (acc. to ISO)

12 Quality Management System (acc. to FDA QSR) Medical Device Reporting Reports of Corrections/ Removal Corrective & Preventive Action Medical Device Tracking Material Control Management Facility & Equipment Controls Records/ Documents/ Change Control Design Control Material Control Production & Process Control Sterilization Process Controls

13 Pharmaceutical Quality System acc. to ICH Q10 Reference: Annex 2, ICH Q10

14 Quality Management System QMS Basic Elements A QMS is based on: Results in: Quality Improvement Quality Planning Quality Control Quality Assurance Alignment with Regulations A Framework Defines Expectations & Deliverables Design Controls + Risk Management

15 Quality Management System SUMMARY Cont. QMS improvement Customer Satisfaction Is Key Evaluate Progress Monitoring ChangeIs Inevitable Feedback System

16 New ISO 13485:2016 (Details)

17 Regulation and Standards New ISO 13485:2016 Effective since March 01 st 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;

18 Regulation & Standards ISO 13485:2016

19 Regulation and Standards Section 4: General Requirements

20 Regulation and Standards Section 5: Management Responsibility 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.

21 Regulation and Standards Section 6: Resource Management

22 Regulation & Standards Section 7: Planning of Product Realization 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. 1 2 Planning of Product Realization Requirement how risk mgt. activities should be handled for product handling. Documented risk mgt. throughout development-planning activities. 6 D&D Verification/ Validation Validation on final production builds; Verification/ validation of user instructions Review of failure modes; 5 3 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) Design & Development Planning 4 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 Communication with Reg. Authorities: Documented arrangements for communicating with regulatory authorities regarding: product information, regulatory inquiries, complaints, and advisory notices.

23 Regulation & Standards Section 7: Planning of Product Realization (cont.) Requirements for Sterile MDs D&D Changes and Files 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 1 2 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 6 Identification & Traceability If UDI is required manufacturer needs to establish and maintain a UDI; 5 3 Supplier Documentation Processes for supplier approvals and monitoring continue compliance. Justifications for selecting suppliers, incl. criteria for evaluation/ reevaluation Shipping conditions and impact on product/ package integrity, incl. sterile device packaging, must be assessed. Validation of Production & Service Provision Requirement to include procedures for validation of sterilization and packaging; Statistical techniques applied and rationale for sample sizes; 4 Purchasing Information Quality agreements required Notification of changes Verification of processes

24 Regulation and Standards Section 8: Measurement, analysis and improvement Feedback Procedures, input to risk management and statistical analysis must be considered. Complaint Reporting Procedures for timely complaint handling/ investigation as well as managing regulatory notifications/ reporting. Measurement Analysis & Improvement 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..

25 New Medical Device Regulation (Europe)

26 New Medical Device Regulation (EU) Background 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.

27 New Medical Device Regulation (EU) 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 IIb medical devices. More rigorous clinical evidence for class III and implantable medical devices. Reclassification of devices according to risk, contact duration and invasiveness.

28 New Medical Device Regulation (EU) Rigorous post-market oversight Implementationof unique deviceidentification Product scope expansion

29 New MDR High-level MDR/ IVDR CE Marking Process 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 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

30 New MDR Transition MDD to MDR TRANSITION Device conforms to current MDD Still able to manufacture, import, distribute & use Only for distribution and use Cannot be used Notified Body according to MDD Can issue certificates according to current MDD Notification according to MDD is no longer valid Device conforms to new MDR Devices can be placed on the EU market. i.e. able to manufacture, import, distribute and use Notified Body according to MDR Notified Bodies can issue certificates according to the new MDR EU portal for registration etc. Existing national registrations remain in place EU portal for HA s only EU portal in use Unique Device Identification (UDI) UDI required in technical and registration data only UDI on labels

31 New MDR Key Impacts 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 new contracts between Legal Manufacturers and Supply Chain actors). Increased Post-Market Surveillance, Vigilance, Clinical requirements.

32 New MDR US Regulator System QSR 21 CFR Part 820 Inspection by FDA EU Regulator System ISO MDR/ IVDR (MDSAP) Assessment by Notified Body (depending on classification) PMA Or 510K Reviewed by FDA FDA US Market Clearance Technical Documentation - Sampled by NB - General Safety and Performance Req. - Risk Assessment - Clinical Evaluation/ Performance Evaluation Manufacturers Declaration of Conformity CE Mark Medical Device Reporting Manufacturer postmarketreq. (incl. complaints and vigilance, (MDR) PMCF, PMPF, PSUR etc. FDA Inspections (24 month) NB QMS Audits (annually) NB QMS / Device Recertification every 5 years.

33 Role of a Notified Body 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 Authorityto 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.

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