European Medical Device Regulations: Keys to Success in this Era of Increased Medical Device Oversight

Transcription

1 European Medical Device Regulations: Keys to Success in this Era of Increased Medical Device Oversight American Medical Device Summit Chicago, IL September 21-22, 2015 Richard DeRisio, M.S. RAC

2 Mark Twain, like most writers, found it easier to write long than short. He received this telegram from a publisher: NEED 2-PAGE SHORT STORY TWO DAYS. Twain replied: NO CAN DO 2 PAGES TWO DAYS. CAN DO 30 PAGES 2 DAYS. NEED 30 DAYS TO DO 2 PAGES. TÜV SÜD America September 22, 22, Slide 2

3 According to an anecdote published in 1918 Woodrow Wilson was asked about the amount of time he spent preparing speeches, and his response was illuminating: That depends on the length of the speech, answered the President. If it is a ten-minute speech it takes me all of two weeks to prepare it; if it is a half-hour speech it takes me a week; if I can talk as long as I want to it requires no preparation at all. I am ready now. TÜV SÜD America Slide 3 September 22, 2015

4 The TÜV SÜD Heritage: 149 years Supporting Business Enterprise Establishment of a Mannheim-based steam boiler inspection association by 21 operators and owners of steam boilers, with the objective of protecting man, the environment and property against the risk emanating from a new and largely unknown form of technology First vehicle periodic technical inspection (PTI) 1926 Introduction of the TÜV mark / stamp in Germany 1958 Development of a Bavaria-wide network of vehicle inspection centres in the late 1950s 1990s Conglomeration of TÜVs from the southern part of Germany to form TÜV SÜD and the expansion of business operations into Asia 2006 Expansion of services in ASEAN by acquiring Singapore-based PSB Group 2009 Launch of Turkey-wide vehicle inspection by TÜVTURK Today TÜV SÜD pursues a strategy of internationalization and growth TÜV SÜD Product AmericaService September 22, 2015 Slide 4

5 MHS Services: Technical Excellence and Broad Industry Knowledge Testing & product certification Inspection Auditing & system certification Knowledge services Training Chemical, physical, mechanical, electrical and software testing as part of product certification. Product, process, components, equipment, systems, buildings. Certification audits in areas including quality system certification: EU, Canada, Japan; product certification to the EU Medical Devices Directives; expedited reviews. Compliance, risk management, quality systems, functional and software safety, clinical research, regulatory strategy. Training in quality systems, risk management, functional safety, mock audits. TÜV SÜD Product AmericaService September 22, 22, 2015 Slide 5

6 Overview 1 Impact of Proposed Changes in EU Medical Device Regulations 2 Accelerating Speed to Market The Notified Body Partnership 3 Unannounced Audits Product Sampling 4 Medical Device Single Audit Program MDSAP 5 Personalized Medicine, Wearable Technology and Smartphone Apps TÜV SÜD Product AmericaService September September 22, 22, Slide 6

7 Pathway of the planned modifications 2012 Commission published draft of the new regulation Now it is called revision and not recast anymore 2014 European Parliament agrees on comments to the draft, and Proposes changes to the draft provided by Commission 2015 Council agrees on comments to the draft, and Proposes changes to the draft provided by Commission 201? European commission, European parliament and Council agree on the final wording of the new regulations TÜV SÜD Product AmericaService GmbH September 22, 2015 Slide 7

8 Slighty Changed: Conformity Assessment Procedures MDD: Classification system stays as is: 4 classes IVDD: Classification system will be introduced, defining 4 different classes Conformity Assessment Procedures will be modified or deleted Important: a manufacturer may choose to apply a conformity assessment procedures assigned for a higher class Class I could be handled as Class III device (including Design Dossier Review) TÜV SÜD Product AmericaService GmbH September 22, 2015 Slide 8

9 New Rules: Rule 8 Rule 8 All implantable devices and long-term surgically invasive devices are in class IIb unless they: are active implantable medical devices or implantable accessories to active implantable medical devices, in which case they are in class III, are breast implants, in which case they are in class III, are hip, knee or shoulder total and partial joint replacements, in which case they are in class III, with the exception of ancillary components such as screws, wedges, plates and instruments, are spinal disc replacement implants and implantable devices that come into contact with the spinal column, in which case they are in class III. TÜV SÜD Product AmericaService GmbH September 22, 2015 Slide 9

10 The IVD Regulation: In Our Lifetime?? ƒhere is the process for responding to a Commission Proposal: First reading (no time limit) Parliament s position (available) Council position (still pending) Second reading Within three months of the communication of the Council s position: EP expresses its position. Within three months of receiving the EP s amendments, the Council approves the amendments or convenes a meeting of the Conciliation Committee within six weeks (the Council shall act unanimously regarding the amendments on which the Commission has delivered a negative opinion). The Conciliation Committee, comprising members of the EP and the Council, must agree on a joint text within six weeks of being convened. ƒthird reading Within six weeks after approval of a joint text by the Conciliation Committee: approval and adoption by Council and EP. The second and third reading periods mentioned above can be extended from three to four months and from six to eight weeks respectively. TÜV SÜD Product AmericaService September 22, 22, Slide 10

11 Key Aspects of the New IVD Regulation The changes called for by the Council primarily focus on the UDI system, the European database, the Notified Bodies, clinical effectiveness / performance characteristics, after-sales product surveillance, vigilance and interaction of competent authorities. Further major changes are: Materials for ring trials are to be exempted from the provisions of the Regulation. The definition of companion diagnostic devices is to be expanded. The rules for reagents produced in health-institution laboratories are to be formulated more precisely. Manufacturers must undertake to implement a full quality management system. The EU Representative is to take legal responsibility for faulty products. A qualified person must also be available with the EU Representative. A scrutiny procedure is only to be initiated after certification of a Class D product in case considered necessary. Class A devices for near-patient testing or with measurement functions are not to be subject to evaluation by Notified Bodies. All devices for self-testing to be classified as Class C. In contrast to the Parliament, the Council has adopted the Commission s proposal of a five-year transitional period and does not demand Special Notified Bodies. The points mentioned do not yet reflect the actual wording of the future Regulation, so that we shall observe further negotiations between the Council, Parliament and Commission with interest. TÜV SÜD Product AmericaService September 22, 22, Slide 11

12 European Commission Resources TÜV SÜD Product AmericaService September July , 2015 Using Your Clinical Notified Data Body Requirements to Accelerate in Speed the EUto Market Slide 12

13 Increasing Oversight Over Notified Body Resources and Expertise Will Your Notified Body Cease to Exist? Accreditation audits conducted by Competent Authority representatives and auditors from different member states. The notified body scope determined by the qualifications and competence of its staff. Special Notified Bodies will be designated to approve Class III high-risk devices and innovative new technology devices. Audits will assess NBs ability to enforce regulations as envisioned by the EP and EC. Potential Survival Hazards Facing Notified Bodies? Lack of sufficient clinical and technical resources limits scope of approvable devices. NB exits device business because of limitations imposed by the Competent Authority. Brain Drain as experts move to more stable NBs. Surviving NBs might not have the capacity to add new device manufacturers. How can you assess whether your NB will survive with its current scope? Clinical/Regulatory risk assessment: Does the NB s level of clinical expertise match your needs (technology, risk, indications)? What is the NB s relationship with the Competent Authority? Does the NB have depth and expertise in staff to assure timely market access? TÜV SÜD Product AmericaService September 22, 22, Slide 13

14 The Scrutiny Procedure Fact or Fiction One Element of the European Commission s Response to Allegations that Review of High-Risk Devices is Not Sufficiently Rigorous to Assure Safety Leaked FDA internal white paper Studies by U.S. medical schools indicated lack of a statistically significant difference High-visibility product performance issues: metal-on-metal orthopedic implants and breast implants filled with industrial grade silicone. The EP and EU have slightly different proposals both are invested in the process Process Not Yet Completely Defined Proposal is for Notified Bodies, Competent Authorities and Others to Nominate Experts Who Will Conduct Scrutiny Reviews TÜV SÜD Product AmericaService September 22, 22, Slide 14

15 The Scrutiny Procedure Devices Will Be Selected for Review on the Following Criteria: New device with novel technology Device presenting a high risk to the patient or user Device in a class known to have caused harm to patients and/or users Scrutiny Review Will Be Conducted in Parallel with the Notified Body Review: Could add 60 or more days to the approval process Risk that a NB could be exposed if its review was deficient Clients use of a rigorous NB can provide a measure of Regulatory Immunity TÜV SÜD Product AmericaService September September 22, , 2015 Slide 15

16 Scrutiny Procedure Commission Proposal Parliament Proposal NB informs COM, submits IFU SNB informs COM COM informs MDCG COM informs MDCG NB submits prel. report to MDCG MDCG may involve ACMD MDCG may involve subgroups ACMD: clinical assessment MDCG may ask for more MDCG may ask for more MDCG comments on prel. report MDCG decides NB takes into consideration SNB needs to follow MDCG decision COM may define more device groups COM may organise meetings TÜV SÜD Product AmericaService September September 22, , 2015 Slide 16

17 European Commission Resources working-groups/cie_wg_index_en.htm TÜV SÜD Product AmericaService September July , 2015 Using Your Clinical Notified Data Body Requirements to Accelerate in Speed the EUto Market Slide 17

18 Equivalence Approach Literature Route Equivalence Approach Same intended use + Technical and biological equivalence + No clinically significant difference regarding safety and performance TÜV SÜD Product AmericaService September July , 2015 Using Your Clinical Notified Data Body Requirements to Accelerate in Speed the EUto Market Slide 18

19 Increasing Requirements for Clinical Evidence and Postmarket Data Areas Attracting Attention of Competent Authorities and Notified Bodies Level and quality of supporting clinical evidence Description of the State of the Art vs. the device pending approval Benefit vs. Risk determinations Where required, Postmarket Clinical Follow-Up study design Clinical Evaluation Reports not keeping pace with clinical evidence expectations Use Your Notified Body s Clinical Preassessment Services Clinical Study Protocol and Statistical Analysis Plan Clinical Study Report PMCF Protocol; Study Design: Representative subjects, users, indications, settings CER design, content and update frequency Level of Notified Body Clinical Expertise: Specialties, Internal, External September 22, TÜV SÜD Product AmericaService Slide 19 September 22, Slide

20 Postmarket Clinical Follow-Up Studies A Guide for Manufacturers and Notified Bodies MEDDEV 2.12/2 Rev 2; January 2012 TÜV SÜD Product AmericaService Slide 20 September 22, 22, Slide 20

21 Postmarket Clinical Follow-Up Studies Post-market clinical follow-up (PMCF) study: A study carried out following the CE marking of a device and intended to answer specific questions relating to clinical safety or performance (i.e. residual risks) of a device when used in accordance with its approved labeling. PMCF plan: The documented, proactive, organized methods and procedures set up by the manufacturer to collect clinical data based on the use of a CE-marked device corresponding to a particular design dossier or on the use of a group of medical devices belonging to the same subcategory or generic device group as defined in Directive 93/42/EEC. The objective is to confirm clinical performance and safety throughout the expected lifetime of the medical device, the acceptability of identified risks and to detect emerging risks on the basis of factual evidence. TÜV TÜV SÜD SÜD America Product Service September September 22, , 2015 Slide 21 Slide 21

22 MEDDEV 2.12/2 Rev 2 Why PMCF? Rare complications or problems become apparent after wide-spread or long-term use of the device. An appropriate Postmarket Surveillance Plan is key to identifying and investigating residual risks associated with the use of medical devices placed on the market. September 22, TÜV SÜD Product AmericaService September July , Slide

23 MEDDEV 2.12/2 Rev 2 Can PMCF be used to demonstrate conformity and place a product on the market? Data obtained from Postmarket Surveillance and PMCF are not intended to replace the premarket data necessary to demonstrate conformity with the provisions of the legislation. September 22, TÜV SÜD Product AmericaService September July , Slide

24 Postmarket Clinical Follow-Up Studies Circumstances That Typically Justify PMCF: Innovation, e.g., where the design of the device, the materials substances, the principles of operation, the technology or the medical indications are novel; Significant changes to the products or to its intended use for which premarket clinical evaluation and recertification has been completed; High product-related risk e.g., based on design, materials, components, invasiveness, clinical procedures; High-risk anatomical locations; High-risk target populations e.g. pediatrics, elderly; Severity of disease/treatment challenges; September 22, TÜV SÜD Product AmericaService September July , Slide

25 Postmarket Clinical Follow-Up Studies (PMCFs) Circumstances That Typically Justify a PMCF (continued): Questions about the ability to generalize clinical investigation results; Unanswered questions of long-term safety and performance; Results from any previous clinical investigation, including adverse events or from post-market surveillance activities; Identification of previously of unstudied subpopulations which may show different benefit/risk ratio e.g. hip implants in different ethnic populations; Continued validation in cases of discrepancy between reasonable premarket follow-up time scales and the expected life of the product; September 22, TÜV SÜD Product AmericaService September July , Slide

26 Postmarket Clinical Follow-Up Studies (PMCFs) Circumstances That Typically Justify a PMCF (continued): Risks identified from the literature or other data sources for similar marketed devices; Interaction with other medical products or treatments; Verification of safety and performance of device upon exposure to a larger and more varied population of clinical users; Emergence of new information on safety or performance; Where CE-marking was based on equivalence. September 22, TÜV SÜD Product AmericaService September July , Slide

27 Postmarket Clinical Follow-Up Studies (PMCFs) PMCF studies may not be required when the medium and long-term safety and clinical performance are already known from previous use of the device or where other appropriate postmarket surveillance activities would provide sufficient data to address the risks. September 22, TÜV SÜD Product AmericaService September July , Slide

28 Overview 1 Impact of Proposed Changes in EU Medical Device Regulations 2 Accelerating Speed to Market The Notified Body Partnership 3 Unannounced Audits Product Sampling 4 Medical Device Single Audit Program MDSAP 5 Personalized Medicine, Wearable Technology and Smartphone Apps TÜV SÜD Product AmericaService Slide 28 September September 22, 22, Slide 28

29 Full product life cycle support Design and development Competence in-sourcing Consideration of international requirements Training Phase 1 Pre-acceptance technical test/ clinical test Tests and appraisals as an extended work bench Assessment of clinical investigation protocols and test data Information on regulations Phase 2 Phase 4 Production monitoring Appraisal, certification and monitoring of quality management systems Recertification Assessment of periodic Clinical Evaluation Reports Phase 3 Testing and certification International approval Processing of approval procedures Conformity assessment as a notified body, including prototype tests, design dossier reviews, consultations with competent authorities and international approvals TÜV SÜD Product AmericaService September 22, 22, 2015 Slide 29

30 Accelerating Speed to Market MHS Americas Initiatives & Services The partnership with your Notified Body contributes to a sustainable competitive advantage: Utilize the Best Practices that have been successful in FDA and other Regulatory Agencies: Presubmissions with FDA. Consultation meetings with the PMDA Regulatory Intelligence Make EU Access and Sustainability a high priority in your organization Don t overlook Electro-Mechanical and Active Implantable Medical Devices Take advantage of services that can make up time when a project is slipping behind schedule Establish clear target dates for approvals and collaborate on metrics (Key Performance Indicators) that assure that the reviews are on track Agree on collaboration if Competent Authority has questions related to vigilance TÜV SÜD Product AmericaService September 22, 22, 2015 Slide 30

31 Accelerating Speed to Market MHS Americas Initiatives & Services How can a strong Notified Body partnership help achieve rapid speed to market? Robust audit, testing and review processes enhance clients risk management programs and increase safety Rigorous and informed feedback enhance the risk management program A dose of Regulatory Immunity Expert clinical and biomedical engineering review services help assure first-pass approval to global markets Clinical study protocols and Statistical Analysis Plans Clinical study reports including data analysis Postmarket surveillance plans Clinical Evaluation Reports content, update triggers and timing TÜV SÜD Product AmericaService September 22, 22, Slide 31

32 Accelerating Speed to Market MHS Americas Initiatives & Services How can a strong Notified Body partnership help achieve rapid speed to market? Premium, customized services can help clients close the gap between product development and market approval. Give me your tired, your poor, your huddled masses yearning to breathe free. Emma Lazarus, engraved on a plaque at the Statue of Liberty Give me your FDA presubmission, your poorly written reports sourced from other departments, your huddled regulatory professionals yearning to breathe free once the submission is approved. Examples of services that can accelerate approval AND help assure safety and reliable performance: Expedited reviews: 5, 30, 60 days vs. the nominal 90-day timeline Preassessments of protocols, test plans, data and devices TÜV SÜD Product AmericaService September 22, 22, Slide 32

33 Accelerating Speed to Market MHS Americas Initiatives & Services Functional Safety Review Identifies dangerous design flaws or potential critical failures Evaluates the design in the context of possible hazards and how it functions under actual use conditions (Human Factors Engineering) Assesses critical design aspects related to reliability and performance Prevents subsequent redesign efforts from delaying the product launch TÜV SÜD is a pioneer in functional safety testing and certification Medical Device Software Safety TÜV SÜD can certify medical device software in accordance with IEC criteria IEC specifies requirements for the development of stand-alone medical device software and software embedded into medical devices TÜV SÜD Product AmericaService September 22, 22, 2015 Slide 33

34 Accelerating Speed to Market MHS Americas Initiatives & Services Special focus on high-tech start-up companies: TÜV SÜD partnership can provide suitors with greater confidence in the value of the acquisition target: QMS compliance, Product safety and reliability Level of clinical evidence to support indications and claims Less likelihood that the deal price will be lowered in anticipation of extensive remedial work required post-close and prior to marketing High-tech companies best positioned to see the value of premium services Working proactively with your notified body can preserve the investors stake in the enterprise and maximize the opportunity for gain TÜV SÜD Product AmericaService September 22, 22, Slide 34

35 Market approval and certification 400 Medical Experts In-house Canada CMDCAS (ISO 13485) CAN/CSA C22.2 NR as NRTL Europe Conformity assessment procedures according to AIMDD, MDD, IVDD (notified body number 0123) Russia Registration Certificate by Roszdravnadzor and declaration of conformity South Korea Technical File Review of class II medical devices CB test reports USA NRTL Certification FDA 510(k) Third Party Review FDA Third Party Inspections Taiwan Audits according to TGMP requirements under the Taiwanese / European Technical Cooperation Program Japan Medical Device Safety Testing according to JIS Certification of class II medical devices Audits according to J-GMP requirements Brazil Factory Inspections via agreements with INMETRO accredited Certification Bodies India Pre-market review according to CLAA Malaysia Conformity Assessment Body (CAB) under the MDA Singapore CAB for medical devices in Singapore GDPMDS certification Product Safety Testing China CFDA Registration Hong Kong Conformity assessment according to MDACS Australia Conformity Assessment Body (CAB) under the current MRA 22, 2015 TÜV SÜD America Product Service Division September 22, 2015 Using Your Notified Body to Accelerate Speed Dr. to Peter Market Havel Slide 35 35

36 Market approval and certification Our market approval services TÜV SÜD s foreign affairs department continuously scans the international regulatory environment and can keep you up to date with the latest regulatory changes concerning medical devices. Providing International Compliance Management (ICM) services, the foreign affairs team can provide step-by-step guidance on how to enter the maximum amount of global markets with your existing TÜV SÜD certification. TÜV SÜD Product AmericaService September 22, 22, 2015 Slide 36

37 What s New? Ongoing field experience: Recalls for similar devices Increase in adverse event reports MedSun surveys for a particular device type Media scrutiny on a device or treatment Congressional inquiries FDA special advisory committee meetings or product-specific Summit Meetings Assess, Analyze, and Position Accordingly September 22, TÜV SÜD America September 22, Slide

38 Overview 1 Impact of Proposed Changes in EU Medical Device Regulations 2 Accelerating Speed to Market The Notified Body Partnership 3 Unannounced Audits Product Sampling 4 Medical Device Single Audit Program MDSAP 5 Personalized Medicine, Wearable Technology and Smartphone Apps TÜV SÜD Product AmericaService September September 22, 22, Slide 38

39 Structure of the September 24, 2013 Recommendations COMMISSION RECOMMENDATION of 24 September 2013 on the audits and assessments performed by notified bodies in the field of medical devices (2013/473/EU) General Provisions of the Recommendations Directed to the Member States Annex I Product assessment Annex II Quality system assessment (Including General advice in the case of outsourcing of the production via subcontractors or suppliers. ) Annex III Unannounced audits September 22, TÜV SÜD Product AmericaService September 22, Slide

40 Unannounced Audit Program Notice September 24, 2013: EU Commission Recommendation on Member State Oversight notified bodies should visit the manufacturer, or one of the subcontractors in charge of processes which are essential for ensuring compliance or a supplier of crucial components or of entire devices. Member States should draw this Recommendation to the attention the notified bodies and should supervise the practice of notified bodies. [Member States] should evaluate the notified bodies readiness to apply this Recommendation and in particular to perform unannounced audits when deciding on designation of bodies and on renewal or withdrawal of designations. TÜV SÜD Product AmericaService September September 22, , 2015 Slide 40 14

41 Unannounced Audit Program (cont d) Unannounced Audits at least Once Every Three Years; more often if: Devices are high-risk, or The particular class/type of devices are frequently non-compliant, or Information suggests that the product or the manufacturer is non-compliant Timing must be unpredictable Manufacturers are obliged to inform notified bodies of shutdown periods Uncertainty as to the availability of key quality management staff Challenge when using non-u.s. auditors Not take less than one day and must include two auditors Subcontractors (processes, components) will be audited when contributing significantly to design, development and manufacturing. TÜV SÜD Product AmericaService September September 22, , 2015 Slide 41 15

42 24 September 2014 European Commission Recommendations [N]otified bodies should, in addition to the initial, surveillance or renewal audits, visit the manufacturer or, if this is likely to ensure more efficient control, one of its subcontractors in charge of processes which are essential for ensuring compliance with legal requirements ( critical subcontractor ) or a supplier of crucial components or of the entire devices (both: crucial supplier ) without prior notice ( unannounced audits ) in accordance with Annex III. September TÜV SÜD Product America 22, 2015Service September 22, 8-Oct Slide 42 16

43 24 September 2014 European Commission Recommendations Notified bodies should establish a risk-based approach to identify such subcontractors and suppliers and should clearly document this decision process. Critical subcontractors or crucial suppliers may be suppliers of suppliers or even suppliers further down the supply chain. Notified bodies need contractual provisions to assure access to all critical subcontractors and crucial suppliers. This clause has implications for manufacturers and notified bodies in regard to routine notified body audits and unannounced audits: The manufacturer must assess the level of control required by subcontractors and suppliers if they are relying on them for crucial components and processes. It might be necessary for a manufacturer to use a consultant to assess the quality and reliability of these crucial components and processes. Notified body audits will provide an objective assessment of subcontractors and suppliers levels of conformance to applicable standards. September TÜV SÜD Product America 22, 2015Service September 22, 8-Oct Slide 43 17

44 Unannounced Audit Program Product Sampling Auditors must select devices for testing: Focus is on Class III devices Check a recently produced adequate sample taken from an ongoing manufacturing process Include verification of traceability of all critical components and the traceability system Include a file review and test of the device Collect relevant testing information, which NB must validate NB performs the test or observes company testing NBs are encouraged to request relevant technical information: final batch testing reports, previous test protocols and results September 22, TÜV SÜD Product AmericaService September 22, Slide

45 Overview 1 Impact of Proposed Changes in EU Medical Device Regulations 2 Accelerating Speed to Market The Notified Body Partnership 3 Unannounced Audits Product Sampling 4 Medical Device Single Audit Program MDSAP 5 Personalized Medicine, Wearable Technology and Smartphone Apps TÜV SÜD Product AmericaService September September 22, 22, Slide 45

46 MDSAP Participating Regulatory Authorities Participants US Food and Drug Administration (FDA) Health Canada Medical Devices Bureau Brazilian Health Surveillance Agency (ANVISA) Australia Therapeutic Goods Administration (TGA) Japan s Ministry of Health, Labour and Welfare, and the Japanese Pharmaceuticals and Medical Devices Agency Observer European Commission TÜV SÜD America Slide 46 September 22, 22, Slide 46

47 MDSAP Objective The overall objective of the Medical Device Single Audit Program is to develop, manage, and oversee a single audit program that will allow a single regulatory audit of a medical device manufacturer conducted by an MDSAP recognized auditing organization (certification body) to satisfy the needs of multiple regulatory jurisdictions. MDSAP will not require changes to country specific regulations The audit is based on ISO plus regulatory-specific requirements of participating countries. TÜV SÜD America Slide 47 September 22, 22, Slide 47

48 MDSAP Goals and Key Strategies A single audit program A single audit to satisfy the regulatory requirements of multiple participants More effective, efficient, and less burdensome regulatory oversight of the quality management systems of medical device manufacturers More efficient and flexible use of regulatory resources Greater global alignment of regulatory approaches and technical requirements Promote consistency, predictability, and transparency of regulatory programs Leverage existing conformity assessment structures TÜV SÜD America September 22, 22, Slide 48

49 MDSAP Pilot Program and Transition Pilot program started in January 2014 and is now underway Six Notified Bodies are in the Pilot Program, Office audits and witnessed audits are required (conducted by regulators) TÜV SÜD BSI LNE SAI TÜV NORD Pilot Program countries are USA, Canada, Brazil, Australia and now Japan. Pilot will finish at the end of Once fully implemented MDSAP will replace CMDCAS in Canada (expectation is 2018) TÜV SÜD America Slide 49 September 22, 22, Slide 49

50 MDSAP Documents Guidance on FDA s Website TÜV SÜD America Slide 50 September 22, 22, Slide 50

51 Audit Man-Days Audit time is based on tasks and not employee count There will be additive and subtractive adjustments Adjustments specific to Design and Development (when applicable) Adjustments specific to Production & Service Control (when applicable) Adjustments specific to assessment of previously cited nonconformities Multiple Site Audits Other adjustments based on ISO/IEC Data will be collected during the pilot program. There could be a new man-day system in place at the end of the pilot program. TÜV SÜD America Slide 51 September 22, 22, Slide 51

52 MDSAP Nonconformities MDSAP use of GHTF document SG3/N19 Nonconformity grading system for regulatory purposes and information exchange Introduces a standardized nonconformity grading system for regulatory purposes that will enable exchange of information among regulatory authorities. Currently, the significance of a nonconformity may vary between regulatory authorities and auditing organizations. Current grading of nonconformities as major or minor does not provide enough detail for global information exchange. TÜV SÜD America Slide 52 September 22, 22, Slide 52

53 Nonconformity Grading Based on GHTF document SG3/N19 Indirect QMS Impact: ISO 13485:2003 clauses 4.1 through 6.3, are seen as enablers (making it possible or feasible) for the QMS processes to operate. These clauses are therefore considered to have indirect influence on medical device safety and performance. Direct QMS impact: ISO 13485:2003 clauses 6.4 through 8.5, are seen as having direct influence on design, and manufacturing controls. These clauses are therefore considered to have direct influence on medical device safety and performance. TÜV SÜD America Slide 53 September 22, 22, Slide 53

54 Grading a Nonconformity Using GHTF document SG3/N19 Nonconformity Step 1 Grading Matrix Absence of documented process or procedure ( add 1) Release of Nonconforming Medical Device (add 1) Step 2 Escalation Rules Final Nonconformity Grade Audit Report + Regulatory Exchange form TÜV SÜD America Slide 54 September 22, 22, Slide 54

55 Participating in the MDSAP Pilot Program / Benefits Any manufacturer may participate if a product falls under the scope of at least one participating Regulatory Authority and subject to their quality management system requirements. The manufacturer may be located anywhere in the world. Only the MDSAP participating countries will have direct access to the audit reports. Regulators will witness some audits to evaluate the Auditing Organizations, not the manufacturer. One benefit is your ability to provide feedback to the regulators and influence the future of the program at the end of the pilot phase. In case you are due or a routine inspection, you potentially can reduce the inspection expenses and resource assignments reduction of audits, cost savings. TÜV SÜD America Iinc. Slide 55September 22, 22, Slide 55

56 Overview 1 Impact of Proposed Changes in EU Medical Device Regulations 2 Accelerating Speed to Market The Notified Body Partnership 3 Unannounced Audits Product Sampling 4 Medical Device Single Audit Program MDSAP 5 Personalized Medicine, Wearable Technology and Smartphone Apps TÜV SÜD Product AmericaService September September 22, 22, Slide 56

57 What will the future bring? There is an enormous appetite for wearable devices and smartphone apps that monitor our health. Casual Health and Medicine: Heart rate, BMI, weight, lean mass, sleep quality. There s a Fitbit product for everyone. Earn badges. Disease Management Glucose level measurement. Exercises to train your eyes based on an initial assessment. Assessing whether a mole poses a risk for skin cancer. Synergy Between Rapid Advances in Technology and the Demand for Convenient Personalized Medicine Devices. Moving from Internet research and self-diagnosis to continuous monitoring of health. TÜV SÜD Product AmericaService September 22, 2015 Slide 57

58 What Are The Implications of New Device Technologies? Many Areas Could Be New to Designers and Developers of Innovative Devices Strict requirements for Verification and Validation Good Manufacturing Practices, Process Capability Process controls to maintain the State of Validation Software Hazards Analysis, V&V, Cyber Security Proof of reliability under anticipated conditions of use (Design Validation) Need for clinical evidence of safety and consistent delivery of the specified performance prospective and postmarket Need for rapid response to customer (and user) reports of malfunctions or injuries Rapid response to sentinel events Proactive vigilance at launch of new products TÜV SÜD Product AmericaService September 22, 22, Slide 58

59 Benefits to your business Key benefits Expert partnership As the most trusted, experienced and reliable service provider, TÜV SÜD works with 75 per cent of the world s largest medical companies. You can be certain of our in-house technological expertise in every field. Accelerate your market access Our flexible support gives you greater control and predictability for your conformity assessment processes. Gain a competitive edge Anticipate future healthcare trends and requirements, and strengthen relevant industry skills with TÜV SÜD s knowledge services and training programmes. One-stop solution Our expertise from initial concept to market launch results in shorter development times, more effective test procedures and swifter product launches. Save time and money Our comprehensive international accreditations, coupled with our extensive office and laboratory infrastructure around the globe, ensure you obtain your worldwide product and system certification efficiently. TÜV SÜD Product AmericaService September 22, 2015 Slide 59

60 Questions, Comments? Questions? Richard DeRisio Vice President, Medical Health Services For Inquiries, please me at: Global website: Stay informed and updated with our Healthcare & Medical Device newsletter: September 22, TÜV SÜD Product AmericaService September 22, Slide