BSI Medical Device Introduction Regulatory Update · 2018-02-09 · Reports/Dashboards Compliance...

Copyright © 2015 BSI. All rights reserved.

BSI Medical Device Introduction Regulatory Update

Tuesday 24th February 2015 London Heathrow &

Thursday 26th February 2015 Nottingham

Gary Slack SVP Global Medical Devices

Copyright © 2015 BSI. All rights reserved. 2

An Ever Changing Regulatory Landscape – Europe and Beyond

• Post PIP Audit Requirements – Unannounced Visits

• Ever Increasing Emphasis on Clinical Evaluation

• Less Acceptance of Equivalence – Data Based!

• “Sea Change” in the Requirements for Post Market Clinical Follow Up

• Relative Success of EU Regulatory Outsourcing is Driving Other Geographies to Review Their Existing

Approaches

• Resource Constrained Governmental Agencies Looking to Third Party Provision

e.g. Medical Device Single Audit Programme (US/Canada/Brazil and Australia)

• Japan Opening Class III Devices to Third Party Providers

• Potential Increased Third Party Activity within the Australian TGA Programme

• Catastrophic Fiscal and Reputational Cost of Adverse Events / Patient Injury and or Non-Compliance


BSI’s is Focusing on Tools to Drive “Enhanced Certification” in order to… Aid Robust, Efficient and Cost Effective Compliance Solutions …to Enable or Maintain Market Access

Maintaining Information

Sources

Standards

How does my organisation understand / interpret.......

How does my organisation… ensure

we are Compliant

Manage Risk

Post Initial Compliance

how does my organisation…

Maintain & Monitor Compliance

Partnering to Succeed and Delivering Excellence

Product Lifecycle

Compliance Tools


Training and Maintaining Competence

How does my organisation understand / interpret.......

Essential Requirements

by Region

By Technology “State of the Art”

Technical Standards

Understanding

ISO 13485

1 Day

MED01001ENGX

Implementing ISO 13485

2 Day

MED02001ENGX

Internal Auditor

ISO 13485

2 Day

MED03001ENGX

Lead Auditor

ISO 13485

5 Day

MED04001ENGX

MED04101ENGX

MED01801ENUS

Introduction to CE Marking

1 Day

MDD1001ENGX

Medical Devices CE Marking

3 Day

MDD41001ENGX

Introduction to IVD Directive

1 Day

VMD01001ENGX

IVD CE Marking

3 Day

VMD41001ENGX

Risk Management

1 Day

MDR01001ENGX

Post Market Surveillance

1 Day

MPM00101ENGX

Drug / Device Combinations

1 Day

MDD41801ENGX

Process Validation

1 Day

PVA00101ENGX

Creating & Maintaining

Technical Files & Design Dossiers

1 Day

TFD00101ENGX

Animal Tissue

1 Day

MAT00101ENGX

CE Marking Devices with

Software

1 Day

SMD41001ENGX

ISO 13485

Clause by Clause

2 Day

MED41011ENGX

Global Requirements

EU, Canada, US, Japan …

Clinical Evaluations

1 Day

MCE01001ENGX

Performance Evaluations

1 Day

Creating & Maintaining IVD Technical Files & Design Dossiers

1 Day

BSI Regulatory Webinars

Free


How Can BSI Support You and Your Clients in Global Expert Certification and Conformity Assessment?

How does my organisation…

Ensure we are Compliant

Manage Risk

Test Compliance to increasing and evolving requirements

Partner with an expert provider

with a Global Reach

CMDCAS Audit Programme

EU Conformity Assessment (CE) ISO 13485 Audit

Conformity Assessment SFDA Conformity Assessment Malaysia (MMDD)

Medical Device Single Audit Programme (MDSAP)

Japan MHLW JPAL Medical Audit Programme

Hong Kong Conformity Assessment

Russian Conformity Assessment (GOST-R)

INMETRO Brazil Product Certification


Monitoring and Maintaining Compliance

Post Initial Compliance how does my organisation…

Maintain compliance Monitor Compliance

Close out non conformities Implement UDI

Monitor Adverse Events (PMCF)

Action Manager

Customer Portal and Org Structure,

Create Findings, Add Users, Configure

Reports/Dashboards

Compliance Mgmt

CAPA Manager and

Audits, Protocols, Checklists, Score-

cards

Knowledge Mgmt

Document Mgmt. Training Mgmt.

Legislation Communication

Assets

Risk Mgmt

Risks Analysis

Methodologies Controls

Performance Mgmt

KPIs, Monitoring records

Objectives and Targets

Incident Mgmt

Incidents Statistics

Product Set of BSI Professional Services (Not BSI NB or Assurance)


BSI Medical Device Introduction Regulatory Update

Thank You

The On-going Revision of the Medical Devices Directives: How Close Are We? Gary Slack


The On-going Revision of the Medical Devices Directives: How Close Are We?

Gary Slack Senior Vice president Global Medical Devices

Hanauer Landstraße 115, 60314 Frankfurt, Germany

Kitemark Court, Davy Avenue, Knowlhill, Milton Keynes, MK5 8PP, UK


Regulatory and Commercial Stakeholder Relationships . . .

A Quick Fling? Something more?


Topics

• Changes to the System - Taking effect Now!

• Controversial or Key Issues Within the proposed Medical Device Regulation

• What is the Likely Timeline?


Changes to the System Now


Triggers for Short Term Changes to the System

• Discovery of a 16 year fraud in PIP breast implants using low quality “industrial grade” silicon oil

• Stress test performed by EU Commission

• Determined that changes were needed to improve early detection and prevent this type of incident

• Other high profile vigilance cases with hips, pelvic floor meshes, pacemaker leads, etc.

• Outcome: short term changes to the system

• Immediate Actions

• Commission Regulation: How Competent Authorities control Notified Bodies

• Commission Recommendation: How Notified Bodies audit Manufacturers


Impact of Immediate Actions

Action Impact

Re-assessment of qualifications and scope of activities of NBs

• NBs submitted to CAs the CVs of all technical experts for high risk devices

• Reduced scope for some NBs?

“Voluntary” Joint Audits of NBs by Designating Authority, Commission (FVO) plus two other CAs

• NBs and Designating Authorities under increasing scrutiny

• Put the spotlight on the differing approaches within the Member States

• Some Pain and Some Gain

Monthly Vigilance Teleconferences • Increasing number of COEN requests • More open COEN requests requiring detailed

follow up

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24 September 2013

COMMISSION IMPLEMENTING

REGULATION (EU) No 920/2013

of 24 September 2013 on

the designation and supervision of notified

bodies under Council Directive 90/385/EEC on active

implantable medical devices and Council Directive 93/42/EEC on medical devices

Directs Competent Authorities how to control

Notified Bodies

COMMISSION RECOMMENDATION

(2013/473/EU) of 24 September 2013 on the

audits and assessments performed by notified

bodies in the field of medical devices

Directs Notified Bodies how to audit Manufacturers

Effective from Jan 2014


Impact of Commission Implementing Regulation 920/2013 on the designation and the supervision of notified bodies: Criteria to be met for the designation of NB

Requirements Impact

Joint Audits of NBs by Designating Authority, Commission (FVO) plus two other CAs

• NBs and Designating Authorities under scrutiny • Highlights different approaches in Member States • More scrutiny of competency requirements, in-house clinicians,

qualifications • Processes and procedures clarified • NBs withdrawing – check NANDO, ask your CA

NB Designation valid for a maximum of five years • No impact yet; will need CA resource • Consistent with CE certification cycle

Extensions and Renewals follow the same procedure as Designations

• Helps consistency; will need CA resource

NBs subject to renewal by 14 October 2016 • Helps consistency; requires CA resource

Designating Authorities shall have sufficient number of competent personnel

• Have they the qualified resource to deliver?


//upload.wikimedia.org/wikipedia/commons/9/98/CH-Gefahrensignal-andere_Gefahren.svg



Impact of Com. Recommendation (2013/473/EU) on audits and assessments performed by NBs – Items to be verified by NB during an audit

Requirements Impact

Annex I: Criteria for NBs performing design dossier and type examinations

• Mainly reinforcement of current good practice • Increased need for clinical studies, less reliance on equivalence

argument • Will clarify time needed for reviews

Annex II: Criteria for NBs performing QMS assessments • Mainly reinforcement of current good practice

Annex III: Unannounced visits to manufacturers, "critical subcontractors" or “crucial suppliers”, in addition to planned audits

• Completely new requirement needing extra product and QMS assessors

• Significant increase in NB workload and resources • IAF rules require planned audit schedules so no scope for

substitution • Gone well in general • Some SMEs feeling burden is disproportionate





The proposed Medical Device Regulation:

Key Issues The Timeline


MDR Proposals – Key Issues 1

• Strengthened Designation Criteria

• Joint Audits: Three Member States and Commission (FVO)

• Unannounced Inspections

Notified Bodies

• Less Equivalence, More Data for High Risk Devices

• Publish Safety and Performance Data

• Post Market Clinical Follow-up

Clinical Evidence

• Scrutiny for High Risk Devices

• Common Technical Specifications

• Qualified Person for Manufacturers and Authorised Representatives Pre-market






MDR Proposals – Key Issues 2

• Central Database and Co-ordination

• Trend Reporting

• Enforcement Activities

Post-Market Surveillance and

Vigilance

• Devices and Economic Operators Registered Centrally

• Unique Device Identification (UDI)

• Implant Cards

Transparency and Traceability

• Central Committees: Scientific Advice, Harmonised Implementation

• Expert Panels

• JRC, Reference Laboratories

Governance and Oversight






MDR Proposal: Other Issues and Member State Divergence

• Other Issues • Invasive devices without a medical purpose

• Classification rules – implants, surgical instruments

• Member State Divergence • Reprocessing or recycling of single-use devices

• Ingested and absorbed devices

• The scrutiny mechanism

• The coordination group

• The role of the experts panel

• Reference laboratories

Great political will to find solutions


The Political Timetable: Optimistic?

Jan 2014

July 2014

Jan 2015

July 2015

Jan 2016

Greek Presidency

Italian Presidency

Luxembourg Presidency

Parliament elections

Rapporteurs appointed

New Commissioners in place

Latvian Presidency

Council reaches general approach?

Begin trilogues?

Conclude trilogues?

Entry into force?

Dutch Presidency

Parliament 1st reading


The Political Timetable: Best Guess

Jan 2014

July 2014

Jan 2015

July 2015

Jan 2016

Greek Presidency

Italian Presidency

Luxembourg Presidency

Parliament elections

Rapporteurs appointed

New Commissioners in place

Latvian Presidency

Council reaches general approach?

Begin trilogues?

Conclude trilogues?

Entry into force?

Dutch Presidency

Parliament 1st reading


Don’t Lose the Legacy Benefits of MDD 93/42/EEC and 2007/47/EC

EU CE Approach

• Evidence suggests EU regime has protected patients equally as well as the most robust Central government Schemes

• Third party provision of manufacturing audit ensure effective coverage of global manufacturers

• Patients access new technology in Europe on average far earlier than other developed markets bringing real health benefits. e.g. minimally invasive surgical products leading to reduced recovery time, reduced hospital stay, return to work economic benefits. http://goo.gl/UMJ2NJ

• Enables EU Industry to Develop and Market New Technology Faster

Governmental Central Approaches

• No evidence to suggest more effective

• Government agencies struggle to resource to meet demand leading to poor coverage and infrequent audit. Examples FDA audit coverage outside US is very low. Backlog Anvisa Brazil and MHLW Japan.

• Patients in the US on average waited three years to access equivalent technology (between 2000 and 2011). For devices approved via PMA circa 43 months delay.

• USA, Japan and Canada moving towards more third party provision

• Other countries would love this advantage

http://goo.gl/UMJ2NJ

BSI Medical Device Introduction Regulatory Update · 2018-02-09 · Reports/Dashboards Compliance...

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Transcript of BSI Medical Device Introduction Regulatory Update · 2018-02-09 · Reports/Dashboards Compliance...