- EU MDR & IVDR Update. - EU Unannounced Visits. - Medical Device Single Audit Program (MDSAP)

Transcription

1 2014 Initiatives on EU/IMDRF Medical Devices MS Requirements - EU MDR & IVDR Update - EU Unannounced Visits - Medical Device Single Audit Program (MDSAP) Paul Brooks Senior Vice President Healthcare Solutions December 9 th 2013 RAPS NJ Chapter

2 EU MDR & IVDR Update on progress and changes 13/12/2013 2

3 EU MDR & IVDR Caution The new regulations are not finalized and subject to change Further details will be added later pre and post application through implementing and delegating legislation 13/12/2013 3

4 3 Directives will become 2 regulations Impact of becoming a regulation Direct entry into force There will be a 3 year transition period for MDD/AIMD There will be a 3 year transition period for IVD A regulation should result in more consistent application Appropriate legal instrument that imposes clear & detailed rules which become applicable in a uniform manner and at the same time throughout the Union 4

5 5 Timelines: Regulation covering MD & AIMD Regulation covering IVD European Parliament 1 ST Reading November nd Reading 1/ Designation of Notified Bodies 3 Year Transition 3Year Transition

6 Delegated Entities under the Proposed Regulation European Commission (EC) EU Member States (MS) EU Competent Authorities (CA) Medical Device Coordination Group (MDCG) Representatives of EU MS Medical Device Advisory Committee (MDAC) Assessment Committee for Medical Devices (ACMD) EU Reference Laboratories (EURL) European Medicines Agency (EMA) Notified Bodies (NB) Special Notified Bodies (SNB) 13/12/2013 6

7 Designation of Notified Bodies and Special NBs Notified Body MDR Class IIa/IIb** IVDR Class B/C *Class I non-sterile / non-measuring **Under MDR Special NB needed for higher risk devices: class III, implantable, devices intended to administer medicinal products 13/12/2013 7

8 Notified Bodies More prescriptive requirements Must have permanent in-house staff: Administrative / Technical/Scientific / Medical / Pharmacological External experts may used on ad hoc and temporary basis as needed Submission for designation of a Notified Body shall be overseen by three experts identified by the EC and MDCG Scopes of designation to better defined relative to competence Only Special Notified Bodies can assess high risk devices Notified Body will apply to EMA to be designated as a Special Notified Body Special Notified Bodies to meet in network, exchange good practice and convergence In-house clinical experts Two experts for each product category at least one in-house 13/12/2013 8

9 Single-Use Devices Single-use device has been tested and demonstrated impossible to reuse. Devices labeled as single-use should really be single-use All devices should be reusable as a rule, unless they are on a list established by the EC after consultation with MDAC Reusable device suitable for reprocessing for multiple patients/procedures 9

10 Economic Operators Manufacturer means the natural or legal person who manufactures or fully refurbishes a device or has a device designed, manufactured or fully refurbished, and markets that device under his name or trademark. Importer means any natural or legal person established within the Union who places a device from a third country on the Union market; Distributor means any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes a device available on the market; Economic operators means the manufacturer, the authorised representative, the importer and the distributor; 10

11 Increased Control of the Supply Chain Manufacturer Crucial Suppliers OEM s Sub contractors Distributers Importers Authorised Representatives 12/13/

12 Key Changes More transparency Registration requirements EU database Economic Operators, Devices, Clinical Investigations, EU requirements for UDI Traceability of devices between economic operators ualified person Few reclassifications under MDR Everything needs classifying under new IVDR rules (7 rules 4 classifications) Rotation of NB auditors Unannounced visits Safety and clinical performance reports Extra scrutiny of high risk devices and IVD s 13/12/

13 Unannounced visits 12/13/

14 Recently Published COMMISSION IMPLEMENTING REGULATION (EU) No 920/2013 of 24 September 2013 on the designation and the supervision of notified bodies under Council Directive 90/385/EEC on active implantable medical devices and Council Directive 93/42/EEC on medical devices Directs Competent Authorities how to control Notified Bodies COMMISSION RECOMMENDATION of 24 September 2013 on the audits and assessments performed by notified bodies in the field of medical devices Directs Notified Bodies how to audit manufacturers Effective from Jan /12/

15 Commission Recommendation on the audits and assessments performed by NBs Annex I Criteria for NBs performing design dossier and type examinations Annex II Criteria for NBs performing MS assessments Annex III Unannounced visits to manufacturers "critical subcontractor" or crucial suppliers 13/12/

16 Unannounced Audits STARTING 2014 At least once every third year and increase the frequency of unannounced audits if the devices bear a high risk, frequently non-compliant or if reasons to suspect non-conformities of the devices or of their manufacturer. The timing of the unannounced audits should be unpredictable. As a general principle an unannounced audit should not take less than one day and should be executed by at least two auditors. Notified bodies may visit premises of critical subcontractors or crucial suppliers if this is likely to provide more pertinent information. In particular if main part of design development, manufacturing, testing or another crucial process is located there. Notified bodies should check a recently produced adequate sample, preferably from the on-going manufacturing process, for its conformity with the technical documentation and with legal requirements. 16

17 Unannounced Audits STARTING 2014 The check should encompass a file review and a test. Test may also be performed by manufacturer under observation of the notified body ("witness testing"). The check of the conformity of device should include verification of traceability of all critical components and materials. There are specified requirements for sampling technical documentation and also auditing manufacturing on-going at time of unannounced audit Audits will be at least 2 assessors for 1 day Manufacturers will have to pay for the visits, travel, testing and security for the assessment team is required If visa s are required to visit any sites, subcontractors or crucial suppliers then an open invitation letter will be included in the contract 17

18 What can you do now to prepare for unannounced visits? Read the recommendation Budget for the cost Prepare a procedure for managing unannounced visits Define responsibilities in the event of an unannounced visits with backups/ emergency contacts Define critical sub contractors and crucial suppliers Review contracts with sub contractors and crucial suppliers Communicate with all staff including reception Explain this is mandatory and impact to certification if they refuse Practice 13/12/

19 IMDRF & Medical Device Single Audit Program (MDSAP) Paul Brooks 19

20 International Medical Device Regulatory Forum (IMDRF) IMDRF was conceived in February 2011 as a forum to discuss future directions in medical device regulatory harmonization. Voluntary group of medical device regulators from around the world who have come together to build on the strong foundational work of the Global Harmonization Task Force on Medical Devices (GHTF) Accelerate international medical device regulatory harmonization and convergence. 20

21 International Medical Device Regulatory Forum (IMDRF) IMDRF Management Committee (MC) regulators: Australia, Brazil, Canada, China, the European Union, Japan and the United States of America Representatives of the World Health Organization (WHO) Regulators from the Russian Federation, Mexico, Asian Harmonization Working Party (AHWP) participate as affiliate organization 21

22 IMDRF Work Groups National Competent Authorities Report Exchange Program Roadmap for Implementation of Unique Device Identification system Medical Device Single Audit Program List of Recognized Standards Regulated Product Submission 22

23 MDSAP Goals Recognize Auditing Organizations (AO) Single Audit by AO would: benefit patient health and patient access leverage regulatory resources minimize medical device manufacturing disruptions due to multiple regulatory audits provide global benefit both on short term goals and longer term goals by IMDRF regulators 23

24 IMDRF MDSAP WG Goal Develop a standard set of requirements documents for auditing organizations performing regulatory audits of medical device manufacturers MS The documents will be applicable to competent authority auditing groups / inspectorates, as well as third party organizations Initial critical step in establishing a single audit program 24

25 MDSAP- Statement of Cooperation (November 2012) Australia Therapeutics Goods Administration (TGA) Brazil Agência Nacional de Vigilância Sanitária (ANVISA) Canada Health Canada/Santé Canada United States of America Food and Drug Administration (FDA) 25

26 MDSAP Cooperation IMDRF Initial Recognition, Surveillance, and Re-Recognition Criteria for MDSAP Recognized Auditing Organizations Standardized Recognized AO Auditor Competency and Competency Maintenance Requirements Standardized Regulatory Authority Assessor Competency and Competency Maintenance Requirements Standardized Audit and Assessment Models Auditing of a Manufacturer by an MDSAP Recognized AO Assessment of MDSAP Recognized AO s by participating Regulatory Authorities 26

27 MDSAP Cooperation Standardized Rating System for Manufacturer Audit Findings Standardized Rating System for Recognized Auditing Organization Assessment Findings MDSAP uality Management System 27

28 MDSAP Pilot Pilot starts in 2014 and runs for three years January 2014 CMDCAS Recognized Registrar s can apply to be AO s Office audit and witnessed audit required Conducted by regulator Annual audits 28

29 MDSAP Manufacturer Audit Criteria GMP requirements of the regulatory authorities One audit to address all Certification will be required Health Canada US FDA Brazilian ANVISA Australian TGA AO Audit 29

30 MDSAP Manufacturer Audit Cycle The Medical Device Single Audit Program is based on a three year audit cycle. The Initial Audit, also referred to as the Initial Certification Audit is a complete audit of a medical device manufacturer s quality management system (MS) consisting of a Stage 1 Audit and a Stage 2 Audit 30

31 MDSAP Manufacturer Audit Cycle The initial Audit is followed by a partial Surveillance Audit in each of the following two years and a complete Re-audit, also referred to as a Recertification Audit in the third year Special Audits, Audits Conducted by Regulatory Authorities, and Unannounced Audits are potential extraordinary audits that may occur at any time within the audit cycle. 31

32 How Regulators will use MDSAP reports Australia: The Therapeutics Goods Administration TGA will use an MDSAP audit report as part of the evidence that is assessed for compliance with medical device market authorization requirements unless the medical device is otherwise excluded or exempt from these requirements or if current policies restrict the use of MDSAP audit reports. Brazil: The Brazilian National Health Surveillance Agency ANVISA will utilize the outcomes of the program, including the reports, to constitute an important input on ANVISA s pre-market and post-market assessment procedures, providing, when applicable, key information that are expected to support regulatory technical evaluation on these issues. Canada: Health Canada HC will use a MDSAP audit as part of their Canadian Medical Device Conformity Assessment System (CMDCAS) certification program. Upon the successful conclusion of the pilot, Health Canada's intent is to implement the Medical Device Single Audit Program, as the mechanism to achieve regulatory compliance for quality management system requirements in Canada. 32

33 How Regulators will use MDSAP reports United States: U.S. Food and Drug Administration s Center for Devices and Radiological Health FDA will accept the MDSAP audit reports as a substitute for FDA routine inspections. Inspections conducted "For Cause" or "Compliance Follow-up" by FDA will not be affected by this program. Moreover, this MDSAP program would not apply to any necessary pre-approval or post approval inspections for Premarket Approval (PMA) applications or to decisions under section 513(f)(5) of the Act (21 U.S.C. 360c(f)(5)) concerning the classification of a device. Japan s Ministry of Health, Labour and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA) are official observers and active participants in the Pilot Program s Regulatory Authority Council and subject matter expert groups. 33

34 MDSAP Pilot January 1, 2014 Recognition of initial participating Auditing Organizations June 1, 2014 Some Auditing Organizations ready to start auditing medical device manufacturers and more will be added as the pilot progresses. 34

35 Find out more lot/ucm pdf

36 What is BSI Doing? Commenting on documents Preparing an internal gap assessment Project plan to prepare Supporting FDA on discussions on MDSAP IT solution / MS Monitoring developments 36

37 Any uestions 37

38 Contact Us Name: Paul Brooks Senior Vice President Healthcare Title: Solutions Address: BSI Sunset Hills Road Suite 200 Reston VA Telephone: Links: 38

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