Regulation of Medical Devices –

International Industry perspective

Dr. Adelheid Schneider, Roche Diagnostics GmbH

Some words about the Roche Group

Challenges to register medical devices worldwide

Points to consider when setting up regulations

Recommendations regarding the regulatory framework

Roche: Basic facts at a glance

• Founded 1896 in Basel, Switzerland

• Founding families still hold majority stake

• Employing 88,500 people

• Currently active in 150 countries on all continents

• Clear focus on healthcare

• Leadership in pharmaceuticals (#3)*

• World’s largest biotech company (position #1)* with truly differentiated medicines in oncology, virology, inflammation, metabolism and CNS

• Leadership in in vitro diagnostics (#1) and pioneer in diabetes management

* Source: Decision Resources, Q4/2014

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Roche Group Our Structure

Chugai

Genentech

Roche Pharma

Diabetes Care

Tissue Diagnostics

Molecular Diagnostics

Professional Diagnostics

Professional

DiagnosticsBusiness Area

Molecular

DiagnosticsBusiness Area

Tissue

DiagnosticsBusiness Area

Diabetes Care

Business Unit

• Serum work area/immuno-

assays and clinical

chemistry

• Point-of-care testing

• Coagulation and specialty

testing

• Workflow management

• Custom Biotech

• Virology

• Blood screening

• Genomics/oncology

• Microbiology

• Women’s health

• Biochemical reagents

• Nucleic acid DNA purifi-

cation and real-time PCR

• Primary staining

• Advanced staining

• Workflow management

• Digital pathology

• Blood glucose monitoring

• Insulin delivery

• Diabetes management

systems

Sequencing Unitoffering sequencing solutions for both

clinical and life science segments

Roche Diagnostics DivisionServing both clinical and life sciences segments

ASEAN Association of

Southeast Asian Nations

The Latin American Alliance for the

Development of In Vitro Diagnostics

PAN AFRICAN HARMONISATION PARTY

Roche is in close interaction with

Some words about the Roche Group

Challenges to register medical devices worldwide

Points to consider when setting up regulations

Recommendations regarding the regulatory framework

1. Various forms of regulation exist to meet different needs

of individual countries.

2. No standardized wording in regulations and guideline

3. Individual Submission dossiers required by each

country

4. Additional requirements such as local testing or special

testing according local standards in some countries

required

Global Registration What are our challenges? (1)

Global Registration What are our challenges? (2)

5. High cost and expertise required to meet different

requirements of regulation systems

6. Long timelines to register products in countries

(sometime up to 3 years)

7. Lengthy and burdensome change approval and Re-

registration processes

8. Inspections from all over the world, different

approach regarding GMP

Some words about the Roche Group

Challenges to register medical devices worldwide

Points to consider when setting up regulations

Recommendations regarding the regulatory framework

To protect public health

and safety by ensuring

safety, quality, and

effectiveness

Fast access to affordable

medical devices

Goal

What have to be considered when setting up

regulations?AHWP PlaybookA Medical Device Regulatory Framework (2014)

Source: Playbook for Implementation of a Medical Device Regulatory Framework , Asian Harmonization Working Party ,Technical Committee (TC)

A guide to countries with no framework

or existing framework.

What have to be considered when setting up

regulations?Summary

Ensure an appropriate balance between pre-

market and post-market elements

Consider the implementation of more advanced

pre-market controls only when you have a base of

registration of your IVD medical device and

sufficient resources

Simplify / standardize the regulatory framework

premarket submissions or approval to market

Some words about the Roche Group

Challenges to register medical devices worldwide

Points to consider when setting up regulations

Recommendations regarding the regulatory framework

Regulatory Framework Follow the GHTF Regulatory Model

15

What is a medical device

What is needed to ensureSafety and performance

How to meet the EssentialPrinciples

What level of Conformity Assessment is appropriate

Supporting Documentation Submission file

What is needed to ensureThe safety of the product

Safe medicaldevice is placedon the market

Definition of medical device and IVD medical device

Essential Principles of Safety & Performance

Use of Standards (or other means)

Guidance on Clinical Evidence

Labeling (including Instructions for use)

Risk based classification Rules – Class A, B, C or D

Summary Technical File (STED)

Audit procedures and protocols

SG 4Post Market Vigilance and

Reporting Procedures

SG 2

SG 5

•Quality System•Design Control Process•Full Technical Evidence

SG 3

Provided by Benny Ohns, PAHWP – Capetown November 29-30, 2014

Regulatory Framework

Pharmaceuticals

Drug

Medical Devices

In vivo use

Active implantableMD

Medical Device

In vitro use

IVDs

Develop separate regulations for Pharmaceuticals,

MDs and IVDs or have different sections addressing

them

Are these all the

same?

Can they have one

regulatory

approach/framework?

Regulatory Framework Consider IVDs are different from Medical Devices

1. IVDs do not treat patients, they are non-invasive tests used on

biological samples (e.g. blood, urine, tissue, etc.)

2. IVDs never come into contact with patients. IVDs always

interact exclusively with samples taken from the patient to

obtain information of relevance.

3. The risks posed by IVDs to patients are based on the

information they provide. The risks to patients are therefore

indirect.

Source EDMA

IVD

Medical Device Active Implantable

Medical Device

Regulatory Framework What is needed to ensure safety and performance?

A manufacturer of a medical device is expected to design

and manufacture a product that is safe and performs as

intended.

’Essential Principles of Safety and Performance’

documented in the so called EP Checklist describes

fundamental design and manufacturing requirements to

ensure safety and effectiveness of the medical

device/IVD.

Regulatory Framework Standards

• Encourage the use of international standards.

• Establish a mechanism for recognizing

international standards to provide

manufacturers with a method of

demonstrating conformity with the Essential

Principles.

• Accept if conformity with the Essential

Principles can be demonstrated by another

means.

Regulatory Framework Clinical Evidence

Accept the global clinical study as

performance characteristics of an IVD

are not influenced by local conditions.

Ask for Local testing only in those rare

cases where there are significant local

conditions that are highly probable of

having influence on the performance.

Keep in mind that clinical evidence for

IVDs is totally different than for Medical

Devices.

Regulatory Framework Risk based classification rules

Establish

classificatio

n and

enhance

conformity

assessment

as

appropriate

Regulatory Framework Conformity Assessment Ensure that the requirements are set according to the risk class and

that lower risk products have accordingly lower requirements.

Class D

Class C

Class B

Class A

Approved QM System

Submission of comprehensive Technical Dossier required

Assessment of clinical performance

Approved QM System

Submission of comprehensive Technical Dossier required

Approved QM System

Submission of basicTechnical Dossier

required

Listing or

notification

only

HIV,

HCV, HBV,

HTLV, ABO,

Rhesus, Kell, and

Duffy System

.PSA, Down Syndrome,

Chlamydia, CMV, Rubella, Huntington, Troponin,

Prothrombin, Monitoring of HIV, Hepatitis B and C, HIV and HCV

genotoyping , Self testing devices an blood gases and

blood glucose determinations

B12, urine test strips, pregnancy self-test

Products not included in Class A, C, D

Controls without a quantitative or qualitative assigned value

Reagents for specific examination.

Instruments for IVD procedures

Specimen receptacles.

e.g., microbiological media, wash solutions, urine cups, culture media

IVD Classification Examples

Conformity assessment procedure

IMDRF, AHWP and WHO issued documents to give

guidance when submitting device information to

authorities

Sect. CSDT

Heading

3.0 Executive Summary

4.1 Essential Principles

4.2 Device Description

4.3 Design Verification and

Validation

4.4 Risk Management

4.5 Labelling

4.6 Manufacturer’s

Information

Agree on a common submission Dossier based on the GHTF

STED document, AHWP CSDT or WHO prequalification dossier

Further recommendationsAbridged registration processes

Acceptance of already available licenses for Roche

devices

Documented Evidence:

Free Sales certificate + ISO certificate of the manufacturer

This is a proof that the device is safe and

effective and fulfills the requirements to

market the device on the European

market including EFTA Member states like

Switzerland (CE-Mark)

Further recommendationsPost market processes Post-market surveillance and adverse events reporting

Establish a national coordinating agency to receive and

manage reports on issues related to medical devices.

Involve manufacturers in investigations of incidents and

resolution of issues before notifying other national competent

authorities.

Changes

Simplify Change Registration Process

This could help to prevent countries from having ready access

to new technologies and even may prevent implementation of

safety relevant changes.

Further recommendationsNomenclature System: What is GMDN?

Global Medical Device Nomenclature (GMDN)

The international standard (ISO 15225) for naming Medical

Devices

Used by 65 national Medical Device Regulators, backed by

IMDRF

Translated into 25 languages

Controlled distribution and updating

International acceptance

Work with one Nomenclature System (GMDN code) for

effective market surveillance, safety management and risk

management.provided by Mark Wasmuth – CEO, GMDN

Agency

Further recommendationsRequirements on Quality Management System

Accept ISO 13485 certificate

for establishment license and

Quality Management System

requirements

Accept IMDRF Single Audit

Program

Thanks for your attention

Thank you to Thomas Mall and Peter Martin for giving input to the presentation.

Disclaimer:

This presentation reflects the Roche position.

All errors in this presentation go on the account of the presenter.

This presentation is our intellectual property. Without our written consent, it shall neither be copied in any manner, nor communicated to third parties.

CV

Education and training

• 1986 - University Diploma – Food Technology Engineer, Hohenheim

• 1996 - Doctor of Science, Sc.D – Hohenheim

Working experience

• 1987-1991 Boehringer Mannheim: Technical Assistant Research and

Development in Protein Chemistry and Enzymology

• 1991-1995 FhG Stuttgart: Assistant Immunology and Cell biology

• Since 1995 Roche Diagnostics GmbH: various positions in Quality Control, Quality

Assurance, Documentation and Regulatory Affairs

Current position

Head of International Registration responsible for Regulatory Affairs for Roche within

the Diagnostic Business Area Roche Professional Diagnostics and

EMEA Reg. Affairs Regional Head for Roche Diagnostics responsible for regulatory

intelligence and advocacy Roche positions externally for Roche Diagnostics

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