medical device regulations: clinical impact · introduction medical device regulation in vitro...

Medical Device

Regulations: Clinical

Impact

European Society of Cardiology

Brussels21 March 2018

Tom Melvin

Medical Officer, HPRA

Co-Chair Clinical Investigation and Evaluation Working Group

Agenda

2

IntroductionMedical Device

Regulation

In Vitro

Diagnostic

Regulation

Implementation

Introduction

Medical Devices

19/03/2018 4

Iterative development vs. disruptive

development

19/03/2018 5

Clinical

Evaluation

Post-Market

data

Clinical

investigation

Clinical data

Changes with the MDR

• Size of

Regulation

• 23 – 123

Articles

• 12 – 16

Annexes

• Legal Basis

• Directive vs.

Regulation

• MEDDEV /

ISO aspects

incorporated

• Scope

• AIMD

• Annex XVI

Slide

8

Medical Device Regulation

MDR – Clinical changes

Clinical evidence

for high risk

devicies

The ‘scrutiny’

procedure

Common

specifications

Summary of

safety and clinical

performance

19/03/2018 10

Clinical Evaluation Consultation – ‘Scrutiny’

• Novelty

• Risk-benefit

• Incident Reports

Criteria

• CEAR

• Risk-benefit

• C/W indication

• PMCF

Expert Panel

Review (CEAR)• Due consideration by

NB

• PMCF/ indication /

SSCP

60 days –

scientific opinion

19/03/2018 12

Competent Authority

Market Surveillance

• Proactive

• Reactive

Scrutiny

• Expert Panel

• High risk devices

Common

Specifications

• Absent / insufficient

standard

• Clinical / technical

guidance

In Vitro Diagnostic Device

Regulation

IVDs

19/03/2018 14

19/03/2018 15

Implementation

CIE: MDR Implementation Work Packages

1. Clinical

Evaluation2. SSCP

3. Template

& Eudamed

4. CIE / IVD

Taskforce

19/03/2018 17

19/03/2018 18

Terms of Reference

Joint Action on Market Surveillance

Member state

communication

Market

surveillance co-

operation

Clinical

resources

Common

specification

prioritisation

19/03/2018 19

Thank You

tom.melvin@hpra.ie

devices@hpra.ie

Health Products Regulatory Authority | An tÚdarás Rialála Táirgí Sláinte

Kevin O’Malley House, Earlsfort Centre, Earlsfort Terrace, Dublin 2,

Ireland

www.hpra.ie