Impact of the MD/IVD Regulations on Quality Management Systems

Transcription

1 Impact of the MD/IVD Regulations on Quality Management Systems Dirk Stynen, Ph. D. President Qarad RMD 2018 Brussels

2 In this presentation: focus on In Vitro Diagnostic Devices... but the same applies to Medical Devices 29/10/

3 Responsibilities Regulatory Affairs Clinical Evidence and Performance Evaluations Labelling Design Control Post-Marketing Surveillance Operations Purchasing and Subcontracting Distribution IVD-R impact on your QMS Areas Impacted 29/10/ of 25

4 Responsibilities Article 15. Person responsible for regulatory compliance ( PRRC ) Responsibilities Conformity of devices appropriately checked before release ( Batch release, ) Technical Documentation and Declaration of Conformity drawn up and up-to-date Post-Marketing Surveillance obligations complied with Reporting obligations (FSCA, Incidents, ) fulfilled Can be different persons 29/10/ of 34

5 Responsibilities Article 15. Person responsible for regulatory compliance ( PRRC ) QMS Actions Respective responsibilities to be defined Qualification of the PRRC Impact on procedures 29/10/ of 34

6 Regulatory Affairs Technical Documentation related Procedure for creating and updating Technical Documentation Structure of Technical Documentation (Annex II) Structure of Technical Documentation on Post-Market Surveillance (Annex III) QMS Actions Create procedure and process for creation and updating Create Templates for TD and TD on PMS E.g. Checklist for General Safety and Performance Requirements New template for Declaration of Conformity 29/10/ of 34

7 Regulatory Affairs Notification of CE marked products to Eudamed and Data Management After introduction of Eudamed: new notification process for CE marked products. Notification by Manufacturer, not Authorized Representative. Significant amount of data to be submitted (Annex VI) UDI QMS Actions New procedure for product notification, including updating of information Define how data will be managed, incl. UDI Define your single source of truth 29/10/ of 34

8 Regulatory Affairs New requirements relating to Authorized Representative QMS Action Revise authorized representative contract Revise processes related to your Authorized Representative 29/10/ of 34

9 Notified Body relationship IVD-R impact on your QMS Regulatory Affairs Unannouced audit (IVD Class C and D) Medical Devices (Class IIa, IIb, III) Change requests Batch release (IVD Class D) and certain Medical Devices QMS Actions Establish procedure for handling unannouced audits (and make sure subcontractors have one!) Procedures for change requests to NB (QMS and product) Procedure for batch release 29/10/ of 34

10 Regulatory Affairs Change Requests Change Control procedure should include Change Request to the Notified Body: For Class D under Annex IX (4.11): for changes that could affect safety and performance (For Medical Devices: Classes IIb and III) For Class C and D: under Annex X (5) (analogous for Medical Devices): any planned change to the approved type or of its intended purpose and conditions of use have to be communicated to the Notified Body approval required for changes Including limitations of its intended purpose and conditions of use... Where such changes may affect conformity with GSPR... Where such changes may affect conformity with the conditions of use Supplement to the Certificate, but change in intended purpose and conditions of use: new application for conformity assessment. 29/10/ of 34

11 Regulatory Affairs Auditing Internal audit program No direct impact, but new regulatory requirements will have to be included in the internal audit plan Supplier audit Increased expectations on control of critical suppliers and subcontractors Unannounced notified body audit At least once in 5 years Can also be audit at critical supplier or subcontractor: are they ready? 29/10/ of 34

12 Clinical Evidence and Performance Evaluations Extensive and detailed requirements for demonstrating Clinical Evidence Extensive and detailed requirements on Performance Evaluation Studies QMS Actions Procedures, Templates for Plans and Reports for Performance Evaluation: Scientific validity report, analytical and clinical performance plans and reports, Procedures, for Performance Evaluation Studies Including, if applicable, for interventional PEs and other PE involving risks for the subjects 29/10/ of 34

13 Performance Evaluation Essential part of the Quality Management System Person responsible for regulatory compliance QMS Post-Market Surveillance System PMPF PSUR Scientific Validity Risk Management System Performance Evaluation Clinical Performance Clinical Evidence Analytical Performance 29/10/ of 34

14 Labelling Annex I, Chapter III, 20.1 (Medical Devices Annex I, Ch. III, 23.1) Such information may appear on the device itself, on the packaging or in the instructions for use, and shall, if the manufacturer has a website, be made available and kept up to date on the website, - Not meant to be a replacement for paper copies - but eifu solutions allowed (except self-testing and near-patient tests) (according to MEDDEV Guidance) - eifu for Medical Devices 23.1: must be compliant with EU Regulation 207/ n if the instructions for use are not provided in paper form in accordance with point (f) of Section 20.1, a reference to their accessibility (or availability), and where applicable the website address where they can be consulted 29/10/ of 34

15 Labelling QMS Actions Consider implementing full e-labeling solution Establish process/procedure for IFU on website 29/10/ of 34

16 Labelling UDI QMS Actions Procedures for managing UDI Printing procedures Language requirements: no change Dangerous substances (CLP and REACH): no change IFU content: longer, more detailed list of requirements 29/10/ of 34

17 Labelling Importer must have name and address on label, or in IFU or on leaflet QMS Action Develop process for this. If action required from importer, ensure that he has process 29/10/ of 34

18 Design Control Notified Body Review Timing Higher expectations More requirements (e.g. clinical performance) QMS Actions (general) Adapt input/output lists Timelines to be adjusted More verification and validation More documentation 29/10/ of 34

19 Requirements for software IVD-R impact on your QMS Design Control QMS Action Is your software life cycle management up to standard? 29/10/ of 34

20 Post Market Surveillance PMS: actively and systematically gathering of information, including: Post-market Performance Follow-up (PMPF) - IVD Post-market Clinical Follow-up (PMCF) Medical Devices Use of information:, update of risk management, update of performance evaluation, PMS Report (Class A and B) (Class I Medical Devices) Periodic Safety Update Report ( PSUR ) (Class C and D) (Medical Devices Classes IIa, IIb, III) QMS Actions Ensure PMS addresses all input and output Process to write and update PMS Reports Process to write and update PSUR 29/10/ of 34

21 Operations Implementation of certain changes only after NB approval Class D: batch release by NB (also applies to certain Medical Devices) Sterilisation QMS Actions Modify change process to include NB communication Modify batch release procedure Ensure sterilisation is up to standard 29/10/ of 34

22 Purchasing and Subcontracted/Outsourced Processes Increased scrutiny over suppliers and subcontractors, including possibly audits and unannounced audits QMS Actions Choose suppliers and subcontractors with adequate QMS, preferably ISO13485 certified Prepare them for NB audits Detailed quality agreements to be put in place 29/10/ of 34

23 Distribution Responsibilities of importers and distributors QMS Actions Streamlining of notification of incidents and FSCA If they change product, ensure that it is compliant with regulations 29/10/ of 34

24 Key Take-Home Messages 1 The IVDR will have a large impact on the Quality Management System. How to manage parallel systems during transition period? 2 Existing procedures will have to be reviewed and revised, new procedures will have to be created. 3 New templates will have to be created (e.g. GSPR, Technical Documentation, DoC etc.) and existing documentation updated. 4 Design change has become more complex due to notified body involvement. 29/10/ of 34

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