Transition to the MDR a practical approach & interactive ... · MDD certificate validity (4 years) June 2022 Annex IV certificates expire No more MDD devices on the market 26 May

8-6-2018

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© 2016 Holland Innovative

Transition to the MDR a practical approach

& interactive session

Holland Innovative

June 2018

Lisette van Steinvoren, MSc.

Sr Project Manager Medical

© 2016 Holland Innovative 2

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The core of Holland Innovative

Automotive HealthEnergyHigh Tech Agro & Food

Products Careo ASMLo Philipso NXP

o Siemenso Deltao Essent

o Boscho DAFo Automotive NL

1Confidential WoW HI Health

o FooDso Greentech

o Start-upso MKBo Multinational


Medical Innovations accelerated

Products

Personalizedmammographic compression.

Role HI: Customer need identification; fact based design, CE approval, project management

Diagnosing aseptic loosening in knee arthroplasty

Role HI: Optimal designed prototype’s and project assurance.

Noviomini tracks bladder filling

Role HI: Customer need identification, risk management, project outline

Development of an integrated PET MRI coil

Role HI: Customer need identification, project management, clinical trial support, risk management

3D Scoliose drill guide

Role HI: CTQ definition,Projectmanagement

Ultrasound sonocoat visibility

Role HI: Quality management (ISO 13485), project management process stabilization and optimization

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Holland Innovative Medical is able to support

Product

Project management compliant with medical regulations

Identifying the complete set of customer needs (the Voice of the Customer)

Translating customer needs in product requirements (CTQs)

Risk management to ensure a safe product (ISO 14971, FMEA)

Design for Six Sigma to create and optimise high quality design

Reliability engineering to meet customers lifetime requirements

Statistical analysis to describe and analyse Design and Process variation (verification & Validation)

Facilitating Design reviews

The certification processes according to CE and FDA approvals

Quality

Set-up a Quality Management System

Transition from ISO13485:2012 to ISO13485:2016

Training on QMS topics

Improvement of Procedures, FRM’s an WI’s, together with the process owners, to create Lean process

Transition from MDD to MDR

Set-up & Manage complete transition project

Coach QMS department

Training

Gap-analyses

Company Confidential Holland Innovative 5


Agenda

Status Check: where are you?

Determine your goal

Gap’s relevant for every Economic Operator

Plan of Action: an example Read Delta’s Cluster Close

When time is left: Challenging topics: Let’s learn from each other System Validation Equivalence ..

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Status Check Regarding MDR compliance within your company

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For all Economic Operators:

Where is your management?

Where are you?


Agenda


Determine your goal

Gap’s relevant for every economic operator



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Transition Timelines

26 May 2017Entry in to force MDR

Transition period of 3 years

26 May 2020Application of MDR

MDD certificate validity (4 years)

June 2022Annex IV certificates expire

No more MDD devices on the market

26 May 2024Last MDD certificates expire

MDD certificates: Max 5 year expiry from issue / renewal data

Today

November 2017Apply for Designation by NoBo’s under MDR

Designation approx. 1.5y

MDR Certificates

~ Q2 2019Apply for MDR cert

No significant changes in design or intended purpose


Example Goal








MDR Certificates




Today


Get MDR Ready

Internal MDR audit

Ready to apply

The goal is to: Have the Company X system & procedures ready to create or update a technical file according to the MDR per December 2018

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What is your goal?








MDR Certificates




Today


? Ready to apply

The goal is to:……

? ? ? ?


Agenda


Determine your goal




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Article 5 – General safety and performance requirements

Essential requirements changed into GSPR


Article 15 – Person responsible for regulatory compliance

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Article 25- Identification within the Supply chain


Article 27 – Unique Device Identification

Medical device

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Article 31 – New responsibilities for economic operators


Article 30 – European database on medical devices

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Article 83 till 86: Post market Surveillance

Annually update:

Reporting deadlines

Always immediately, but never later then:

Serious public health threat: 2 days Event of death or serious deterioration: 10 days - Serious incidents: 15 days


Agenda


Determine your goal




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There is no 1 size fit’s all…….

… therefore this presentation focuses on a practical approach, which you can use (hopefully) to manage your own transition

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Project plan MDD to MDR

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The goal is to: Have the Company X system & procedures ready to create or update a technical file according to the MDR per December 2018

Company X is a legal manufacturer of Medical Accessories, used in imaging of Class IibThe company has several locations and own development & production facilities

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Work packages | Main deliverables & Deadlines

1• Prepare

& Kick-off

2

• Delta’s & Gap’s

3

• Business decision’s

4

• Close-gap’s

5

• Intern Audit

30-1-2018 15-4-2018 1-6-2018 1-9-2018 1-10-2018

Matrix impact of Gap’s Proposal: Strategic Decision per

product group

Internal Audit on MDR readiness of QMS (does this procedure result in MDR approved products?)

Internal Audit on 1 or 2 Technical files according to MDR

Q1 2019

Close CAPA

Ready to create/update file’s


Practical approach: Read | Capture & Share: what is relevant for your organization

1

• Prepare & Kick-off

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2


Practical approach: Determine & Document Delta’s for your organization


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Practical approach: Know the impact & who you need to close the gap’s

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3

• Business decision’s

Products Action focus

Gap’s Measuring

Chamber

Mammography

paddle

Collimator

Competences ++ - 0 2

Production +++ - + 1

Annex route + 3

Availability of

clinical data

0 - - -

Business

decision

Start redesign

project

No impact Stop

Practical approach: Summarize impact Decide: Products | NoBo | Extra resources needed


4

• Close-gap’s

Practical approach: Cluster Delta’s in Gap’s& Document your approach: Plan Do Check Act

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4

• Close-gap’s

Practical approach: Log the statusImplement the created MDR templates & procedures for product(s)


5

• Intern Audit

Practical approach: Plan an (External) Internal Audit on:MDR Readiness of QMS System & Updated Technical file

ISO 13485:2016 MDR 2017/745

For the Technical file which is strategically the most relevant (Update of new release expected)

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Finish

Close MDD to MDR Project: Goal Reached? MDR Compliant?








Today

Get MDR Ready Ready to apply


Agenda


Determine your goal




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Challenging topics: System Validation


Realistically: Equivalence can only be used when the complete Technical file is at the Company

Challenging topics: Equivalence

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Thank you !

Success with your transition!

Contact us for support:

www.Holland-innovative.nl

[email protected]

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http://www.holland-innovative.nl/

Documents

Transition to the MDR a practical approach & interactive ... · MDD certificate validity (4 years) June 2022 Annex IV certificates expire No more MDD devices on the market 26 May