Medical Devices: They Matter Too! - WHO · Drug eluting stents Deep brain stimulators Microneedle...

Technical Briefing Seminar 25 November 2015 1 |

Medical Devices:

They Matter Too!

Josée Hansen Melissa Gómez

[email protected]

November 2015


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?


Do you know the acronyms?

IMDRF

DITTA

GMTA

ICH

Meddev

UMDNS

GMDN

INN

MDSAP

eCTD

IFPMA

PMS

RPS


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


medicinal product medical device

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.

… 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.

http://www.who.int/medicines/services/expertcommittees/pharmprep

/20111208_QASterminologyDB.pdf?ua=1 GHTF/SG1/N071:2012


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


Commonalities and differences

Medicines Medical devices (+IVDs)

Benefit/risk assessment Each individual product Risk classes. Premarket

assessment of high risk medical

devices

Nomenclature International Non Proprietary

Name

GMDN

UMDNS

ISO 9999

UNSPSC

Others

Industry composition Dominated by large

multinationals; Small # of SMEs

Over 80% SMEs;

20 companies dominate sales

revenue

Sales global 900 billion US$ > 500 billion US$


Regulation

Medicines Medical devices

Regulatory framework

All countries 55% of countries for MDs,

Less for IVDs

Medicines Medical devices

US

1937 1976

EU 1965 1993

Beginning of Regulatory Controls


medicines medical devices

Number of guidance

documents

developed by WHO

• > 75 general QA standards,

good practices, guidelines

• 625 test specifications included

in the International

Pharmacopeia

• > 200 international chemical

reference standards

good review practices for

medicines and medical devices

blood products

< 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

Guidance by WHO


Medicinal products Medical devices

efficacy safety and performance

interaction with the human body compatibility

placebo controlled and comparative studies clinical investigation

large numbers of patients included clinical evaluation

data not published

Clinical Trials

/blind.gif2http://www.thejabberwock.org/blog/ .html1_F2249/fig_tab/nm.11/n16http://www.nature.com/nm/journal/v

Performed by: Performed by:

Doctors Engineers

incremental improvements


Marketing Authorisation


one single system concept of risk class: essential requirements applicable to

all risk classes

competent authority determines prescription status risk assessment by manufacturer

assessment of clinical trials bibliographic data

benefit / risk safe at the intended purpose; risk / benefit

Competent Authority, experts Conformity Assessment Bodies

national licenses for an established market Prioritization of products in an existing market

high threshold low threshold



prescribing and dispensing strictly regulated prescribing and dispensing not regulated, linked to

professional skills

responsibility assigned no single responsibility assigned

efficacy is not dependent on context: skills and physical

environment

efficacy and effectiveness are context dependent

treatment guidelines available medical devices included in a treatment guideline to a

limited extend

effectiveness studies performed limited benefit / cost data

comparative studies; systematic reviews very limited data publicly available

Use



pharmacovigilance legislation: new and detailed PMS system in legislation

responsibility of Marketing Authorisation Holder responsibility of manufacturer

reporting system regulated and well established not properly implemented by manufacturers and monitored

by authorities

effective? few data

Post Market Surveillance


WHO Initiatives

Prequalification for IVDs – http://www.who.int/diagnostics_laboratory/evaluations/en/

Management in health care – http://www.who.int/medical_devices/management_use/en/

Regulation


Medical products should be safe and

effective

Resolution WHA 67.20: Regulatory

System Strengthening for medical products

Member states request for support

on regulatory system

strengthening

Increasing importance of

medical devices: regulating an

existing market

Globalizing world

Lack of regulation in many member

states

Justification

)en.pdf21456en/s21456http://apps.who.int/medicinedocs/documents/s(


Preliminary Results: Global Trends

N=194

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

Low Income

Lower middle Income

Upper middle income

High Income

Regulatory Status of Medical Devices by Income Group

Countries that have Regulations Countries without regulations

23%

53%

55%

80%

57% 28%

15%

Countries with Regulations or Guidelines on Medical Devices

Countries with Regulations

Countries with no regulations

Data not available


Preliminary Results: Regional Trends

N=194

47

23

5

12

9

14

6

12

6

15

12

33

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

EURO

AMRO

SEARO

WPRO

EMRO

AFRO

Regulatory Status of Medical Devices by Region

Countries with Regulations

Countries with no regulations


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


Publications

http://new.paho.org/hq/dmdocuments/2009/AmodelRegulatoryProgramforMedicalDevices_AnInternal

Guide.pdf?ua=1

A Model Regulatory Program for Medical

Devices: An International Guide

2001 PAHO

http://apps.who.int/iris/bitstream/10665/42744/1/9241546182.pdf

Medical Device Regulations: Global

overview and guiding principles 2003 WHO

http://www.imdrf.org/docs/ghtf/final/steering-committee/technical-

docs/ghtf-sc-n1r13-2011-ad-hoc-regulatory-model-110413.pdf

The GHTF Regulatory Model 2011

http://www.ahwp.info/sites/default/files/ahwp-

files/8_Call_for_Comments/TCOB/AHWPTC_P01_2014.pdf

AHWP Playbook for implementation of

medical device regulatory

frameworks 2014


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


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


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


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


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)


Basic Elements

58%

51%

65%

52%

60%

41%

57%

60%

23%

Essential principles

Labelling

Registration of Devices

Registration of Establishment

Import controls

Market surveillance

Adverse event reporting

Enforcement

FSCA Monitoring

Pre-Requisites

Pre-Market

Post-Market

N=110


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?


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


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)

Medical Devices: They Matter Too! - WHO · Drug eluting stents Deep brain stimulators Microneedle...

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