Medical Devices: They Matter Too!

Transcription

1 Medical Devices: They Matter Too! Josée Hansen Melissa Gómez November

2 Outline Commonalities and differences between medicines and medical devices Status of medical device regulations worldwide Model Regulatory Framework for medical devices What do you think are the major challenges in regulating medical devices? 2

3 Do you know the acronyms? PMS IMDRF DITTA ICH UMDNS Meddev GMDN INN ectd IFPMA MDSAP RPS GMTA 3

4 Medicinal product or medical device? Condom Pregnancy test Artificial tears Surgical gloves Alcohol A steriliser Glucose 5% Dialysis solution Drug eluting stents Deep brain stimulators Microneedle patch with vaccine 4

5 medicinal product Any substance or mixture of substances that is manufactured for sale or distribution, sold, supplied, offered for sale of presented for use in: (i) the treatment, mitigation, cure, prevention or diagnosis of disease, an abnormal physical state or the symptoms thereof and abnormal physiological conditions in human or animal; or (ii) the restoration, correction or modification of organic functions in human or animal. / _QASterminologyDB.pdf?ua=1 medical device instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings, for one or more of the specific medical purpose(s) of: -diagnosis, prevention, monitoring, treatment or alleviation of disease, -diagnosis, monitoring, treatment, alleviation of or compensation for an injury, -investigation, replacement, modification, or support of the anatomy or of a physiological process, -supporting or sustaining life, -control of conception, -disinfection of medical devices, -providing information by means of in vitro examination of specimens derived from the human body; -and does not achieve its primary intended action by pharmacological, immunological or metabolic means. GHTF/SG1/N071:2012 5

6 Commonalities and differences Medicines Medical devices (+IVDs) Diversity Approx. 40 NCE s /year >>> 100,000; average commercial life cycle 18 months Innovation Revolution Incremental improvement Durability Single use Single use, multiple use, permanent Responsibilities Physician; pharmacist Usually not assigned Context for use Independant Higly dependant Clinical guidelines Detailed prescribed Not mentioned 6

7 Commonalities and differences Medicines Medical devices (+IVDs) Benefit/risk assessment Each individual product Risk classes. Premarket assessment of high risk medical devices Nomenclature Industry composition International Non Proprietary Name Dominated by large multinationals; Small # of SMEs GMDN UMDNS ISO 9999 UNSPSC Others Over 80% SMEs; 20 companies dominate sales revenue Sales global 900 billion US$ > 500 billion US$ 7

8 Regulation Medicines Medical devices Regulatory framework All countries 55% of countries for MDs, Less for IVDs Beginning of Regulatory Controls Medicines Medical devices US EU

9 Guidance by WHO Number of guidance documents developed by WHO medicines > 75 general QA standards, good practices, guidelines 625 test specifications included in the International Pharmacopeia > 200 international chemical reference standards blood products medical devices good review practices for medicines and medical devices < 10 guidelines IVDs as part of PQ biotherapeutics including vaccines 7 general documents for both vaccines and biotherapeutics 8 general documents all vaccines 5 biotherapeutic specific 57 vaccine specific 9

10 Clinical Trials Medicinal products efficacy interaction with the human body placebo controlled and comparative studies large numbers of patients included Performed by: Doctors Medical devices safety and performance compatibility clinical investigation clinical evaluation data not published Performed by: Engineers incremental improvements 2/blind.gif 10

11 Marketing Authorisation Medicinal products one single system competent authority determines prescription status Medical devices concept of risk class: essential requirements applicable to all risk classes risk assessment by manufacturer assessment of clinical trials benefit / risk Competent Authority, experts national licenses for an established market high threshold bibliographic data safe at the intended purpose; risk / benefit Conformity Assessment Bodies Prioritization of products in an existing market low threshold 11

12 Use Medicinal products prescribing and dispensing strictly regulated responsibility assigned efficacy is not dependent on context: skills and physical environment treatment guidelines available effectiveness studies performed comparative studies; systematic reviews Medical devices prescribing and dispensing not regulated, linked to professional skills no single responsibility assigned efficacy and effectiveness are context dependent medical devices included in a treatment guideline to a limited extend limited benefit / cost data very limited data publicly available 12

13 Post Market Surveillance Medicinal products pharmacovigilance legislation: new and detailed responsibility of Marketing Authorisation Holder reporting system regulated and well established effective? Medical devices PMS system in legislation responsibility of manufacturer not properly implemented by manufacturers and monitored by authorities few data 13

14 WHO Initiatives Prequalification for IVDs Management in health care Regulation 14

15 Justification Medical products should be safe and effective Member states request for support on regulatory system strengthening Globalizing world Resolution WHA 67.20: Regulatory System Strengthening for medical products Increasing importance of medical devices: regulating an existing market Lack of regulation in many member states ( 15

16 Preliminary Results: Global Trends Countries with Regulations or Guidelines on Medical Devices 15% Regulatory Status of Medical Devices by Income Group Low Income 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% 23% 28% 57% Lower middle Income 53% Upper middle income 55% Countries with Regulations Countries with no regulations Data not available High Income Countries that have Regulations 80% Countries without regulations N=194 18

17 Preliminary Results: Regional Trends Regulatory Status of Medical Devices by Region 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% EURO 47 6 AMRO SEARO 5 6 Countries with Regulations WPRO Countries with no regulations EMRO 9 12 AFRO N=194 19

18 Model Regulatory Framework A Model Regulatory Framework for medical devices including IVD s with global input and reflecting a modular approach in regulating medical devices How to begin regulating? What to regulate: harmonized definitions and guiding principles How to regulate: stepwise development and implementation When to regulate: priorities and transitional period 20

19 Publications A Model Regulatory Program for Medical Devices: An International Guide 2001 PAHO Medical Device Regulations: Global overview and guiding principles 2003 WHO The GHTF Regulatory Model 2011 AHWP Playbook for implementation of medical device regulatory frameworks nts/2009/amodelregulatoryprogr amformedicaldevices_aninternal Guide.pdf?ua= /42744/1/ pdf l/steering-committee/technicaldocs/ghtf-sc-n1r ad-hocregulatory-model pdf files/ahwpfiles/8_call_for_comments/tcob /AHWPTC_P01_2014.pdf 21

20 What s new? Targeting member states with no or limited regulations Emphasis should be put on market oversight Priority setting in terms of regulation: stepwise approach (basic, intermediate, full) Reliance National competencies Pre-requisites for developing and implementing regulation 22

21 The Model Regulatory Framework for medical devices does not cover: Establishing a single nomenclature system Norms and standards for medical devices Guidance on combination products Financing of the regulatory system for medical devices 23

22 Working Group Members Mr. Abdullah S. AL- Dobaib Executive Director of Registration and Licensing, Saudi Food and Drug Authority Tuncay Bayrak Assistant Health Expert, Republic of Turkey Ministry of Health Michael Gropp Alan Kent Consultant Agnes Kijo Manager, Medical Devices and Diagnostics Registration, Tanzania Food and Drugs Authority (TFDA) Niall MacAleenan Medical Device Lead/Clinical Asessment and Policy Manager, Health Products Regulatory Authority, Ireland Nancy Shadeed Special Advisor, Health Canada Maura Linda Sitanggang/ Lupi Trilaksono Director General of Pharmaceutical Services and Medical Devices, National Agency of Drug and Food Control, Indonesia Shelley Tang Stellar Consulting Kim Trautman Associate Director, US Food and Drug Administration Woei Jiuang Wong Director, Health Sciences Authority, Medical Device Branch, Health Products Regulation Group, Singapore 25

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25 Stepwise Approach Basic Elements Establishment of Essential Principles of Safety and Performance Issuing guidance documents on regulatory requirements Registration of manufacturers, importers and distributors Listing of medical devices placed on the market Import controls Market surveillance, supply chain control, traceability Labelling and instruction for use controls Serious adverse events, recalls, FSCAs or withdrawal from market in exchange with other NRAs Provision for exemptions from regulatory requirements e.g. donations and humanitarian use. Enforce regulations 29

26 Stepwise Approach Intermediate Elements QMS including good record keeping requirements Administrative controls for reliance Recognition and adoption of international standards Control of advertising Adverse event reporting within a vigilance system* Full Implementation Premarket decision on compliance of medical device with essential principles (with reliance and/or review) Notification of clinical investigations and/or serious deviations and/or adverse events QMS auditing (by reliance and/or by auditing) Appoint and oversee CABs Establishment of a test laboratory function (national or regional or by reliance) Mechanism for analyses and dissemination of alerts on medical devices (national, regional, international) 30

27 Basic Elements Pre-Requisites Essential principles 58% Labelling 51% Pre-Market Registration of Devices 65% Registration of Establishment 52% Import controls 60% Post-Market Market surveillance 41% Adverse event reporting Enforcement 57% 60% FSCA Monitoring 23% N=110 31

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31 Questions? In your opinion, what is the future of medical devices? What can WHO do to take this further? How can your organizations be involved? How can the countries you represent benefit the most? 36

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33 Next steps and time line First draft of the Model Regulatory Framework for medical devices January 2015 Public Consultations in April and August In parallel: regional awareness workshops Under discussion: self assessments and capacity building on request of member states In parallel: NRA assessment if applicable 44

34 Partners Member States IMDRF members Asian Harmonization Working Party (AHWP) Pan African Harmonization Working Party (PAHWP) Regional Advisers Experts Other stakeholders (industry, consumers, NGO s) 45