Medical Devices: how interesting they are!

Transcription

1 Medical Devices: how interesting they are! Josée Hansen 20 October

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 Take home message 3

4 Some questions Thinking of medical devices How do I know they are safe? Are they tested before being placed on the market? Who can I ask when I have questions? Does the doctor know how to use a device safely? Adverse events: where to go? 4

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

6 Definitions 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. 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. 6

7 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 7

8 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$ 8

9 Regulation Medicines Medical devices Regulatory framework All countries 58% of countries for MDs, Less for IVDs Beginning of Regulatory Controls Medicines Medical devices US EU

10 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 10

11 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 11

12 Marketing Authorisation Medicinal products one single system competent authority determines prescription status assessment of clinical trials benefit / risk Competent Authority, experts national licenses for an established market high threshold Medical devices concept of risk class: essential requirements applicable to all risk classes risk assessment by manufacturer bibliographic data safe at the intended purpose; risk / benefit Conformity Assessment Bodies Prioritization of products in an existing market low threshold 12

13 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 13

14 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 14

15 WHO Initiatives Prequalification for IVDs Management in health care Regulation 15

16 WHO Mandate WHA Regulatory System Strengthening for medical products to prioritize support for establishing and strengthening regional and subregional networks of regulatory authorities, as appropriate, including strengthening areas of regulation of health products that are the least developed, such as regulation of medical devices, including diagnostics; 16

17 Regulatory status: global 17 Global Survey on the Status of Medical Device Regulations September 2015

18 WHO regions Regulatory status by region Regulatory Status of Medical Devices by Region AFRO AMRO EMRO Countries with Regulations EURO SEARO WPRO Countries without Regulations Data not available N=194 Number of countries 18

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20 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

21 WHO Global Model 21

22 Working Group 22

23 Target audience Countries with no or limited regulatory framework in place With the ambition to improve this situation The legislative, executive and regulatory branches of government 23

24 Convergence and harmonization Convergence and harmonization Definition of a medical device Classification of medical devices Essential principles of safety and performance QMS Standards Confidence building and Information sharing Reliance and recognition 24

25 Two steps approach Basic level controls and enforcement Legal framework Market oversight Reporting system Expanded level controls and enforcement regulatory controls depending on the priorities of the country 25

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27 Regulating medical devices - challenges Less developed regulatory systems than for vaccines and medicines, particularly in LIMC s Lack of awareness Characteristics of medical devices as a product group Regulating in an existing market Lack of specialized knowledge and resources to draft and implement medical devices regulations Lack of resources 27

28 Good regulatory practices Critical elements for regulating medical devices Political commitment Legal framework Implementation plan Competent authority with enforcement power Involvement of stakeholders Transparent and impartial Importance of convergence, harmonization, reliance and recognition 28

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33 Take home message 33

34 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? 34

35 Thank you very much 35

36 Objective of the WHO Global Model A Model Regulatory Framework for medical devices including IVDs with global input and reflecting a modular approach in regulating medical devices to be used by national regulatory agencies in order to formulate laws and regulations to define and control the national market in medical devices in the interest of public health 36

37 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 37

38 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/amodelregulatory Progr amformedicaldevices_aninternal Guide.pdf?ua=1 ho.int/iris/bitstream/1 0665/42744/1/ pdf w w.imdrf.org/docs/ghtf/fina l/steering-committee/technicaldocs/ghtf-sc-n1r ad-hocregulatory-model pdf w w.ahwp.info/sites/default/ files/ahw p- files/8_call_for_comments/tcob /AHWPTC_P01_2014.pdf 40

39 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 42

40 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 43

41 Do you know the acronyms? PMS IMDRF DITTA ICH UMDNS Meddev GMDN INN ectd IFPMA MDSAP RPS GMTA 45