MEDICAL DEVICE SEMINAR

ISO 13485:2016 & MDR

May 2016
 Presenters
Fergal O’Byrne
Head, Business Excellence, NSAI
Susan Murphy
European Medical Device Operations Manager
Mary Murphy
Lead Auditor, Medical Device Department
Aishling Owens
Lead Auditor, Medical Device Department
Lisa Mee
Lead Auditor, Medical Device Department
Certification Overview
Welcome to NSAI - Aims of the morning

 A time of change for many Certification

Management Standards

 Understanding changes & their impacts

 Management Standards – general

 ISO 13485:2016 Medical Devices -QMS

@NSAI_Standards
Why change ISO Standards?

 ISO Review and Revise to support Continual

Improvement and Best Practice – the HLS

 ISO has supported the mantra of ‘Integration’ for

many years – the HLS. See ISO guide

 NSAI audits, reports and audit teams delivered an

integrated service – the HLS in practice

 Standards needed to catch up – 32 HLS MS by now

Management Systems Certification
Main Certification schemes –
a time of great change All HLS
 ISO 9001:2008 to 2015, Quality
 ISO 14001:2004 to 2015, Environment
 OHSAS 18001:2007 to ISO 45001:2016/17 Occupational
Health & Safety
 Three year transition period – period of co-existence
 Common Language
 Common Structure - HLS
 Ease of integration
 Reduced: work, costs, less disruption, better
understanding
 Aligned with the business - a Business Standard
Order out of Chaos
High level structure 

1 Scope
2 Normative references
3 Terms and definitions
4 Context of the organization
5 Leadership
6 Planning
7 Support
8 Operation
9 Performance evaluation
10 Improvement
High level structure (1)
Context (4)

Leadership
(5)

Improvement Planning
(10) (6)

Performance
Support
Evaluation
(7)
(9)

Operations
(8)
ISO 13485:2016 – odd one out

 ISO 13485:2016 revised but not in line with the HLS

 ISO TC 210 ducked the HLS for 3 and possibly 5 years

 ISO 9001:2015 and ISO 13485:2016 no longer in line

 Need to map the gaps – guidance to follow

NSAI
Dedicated NSAI team

Jackie Mateer – Medical Devices

E: jackie.mateer@nsai.ie T:01 8073861
Gwen Thornberry – Medical Devices
E: gwen.thornberry@nsai.ie T:01 8073929

Jennifer Casey – General Management Systems

E: jennifer.casey@nsai.ie T: 01 8073817
Patricia Whelan – General Management Systems
E: patricia.whelan@nsai.ie T: 01 8073993

Events:
 ‘A Clients perspective’ ISO 9001:2016 & ISO 14001:2015 – Autumn 2016
 QI Conference November 2016
 ISO 45001:2016/17 ‘Understanding the Changes’
ISO 13485:2016
Are you ready for
ISO 13485:2016?

New Technologies
New Regulations
New Era
What’s New in ISO 13485:2016?

 ISO 13485:2016 did NOT follow ISO 9001:2015

into the Higher Level Structure format
• ISO 9001:2015 now has 7* QS core “Processes”
• ISO 13485:2016 retains 5* QS core “Processes”

 Annex B of ISO 13485:2016 provides a handy

cross-reference between ISO 9001:2015 and
ISO 13485:2016 normative requirements.
*(excluding: Scope, Normative References, Terms & Definitions)
What’s New In 2016?

Introduction - General
 The standard “can be used by an organization involved
in one or more stages of the life-cycle of a medical
device”

 And, by suppliers and other external parties

providing product to such organizations
What’s New In 2016?

Section 1 – Scope

 1.2 - Any requirement of Clause 6, 7, or 8 can be

deemed “not applicable” to the organization
(with documented justification)
What’s New In 2016?

Section 1.2 – Scope

 Of Particular Note in 1:

“The processes required by this International Standard that

are applicable to the organization, but are not performed
by the organization, are the responsibility of the
organization and are accounted for in the
organization’s quality management system by
monitoring, maintaining, and controlling the
processes.”
What’s New In 2016?

Section 4 - Quality Management System

4.1 – General (software):

 New Technologies
 4.1.6 – Requires documented procedures for the
validation of software used in the Quality Management
System
 4.1.6 – Such software shall be validated prior to initial
use, and as appropriate, after changes
What’s New In 2016?

Section 4 - Quality Management System

*4.2.3 - Medical Device File:

 For each medical device type or medical device

family, the organization shall establish and maintain
a file(s) either containing or referencing documents
generated to demonstrate conformity with the
requirement of this International Standard and
compliance with applicable regulatory requirements.
 Regular references to the regulatory requirements

(*New sub-clause)
What’s New In 2016?

Section 6 - Resource Management

6.2 – Human Resources/ Competence
• The organization shall document the process(s) for
establishing competence, providing needed
training, and ensuring awareness of personnel
6.3 – Infrastructure:
• The organization shall document the requirements
for the infrastructure needed to achieve conformity to
product requirements, prevent product mix-up and
ensure orderly handling of product
What’s New In 2016?

Section 7.3 - Design and Development

7.3.2 – Design and Development Planning
• The organization shall plan and control the design
and development of product
• During design and development planning, the
organization shall document:
 the methods to ensure traceability of design and
development outputs to design and development
inputs; and
 the resources needed including necessary
competence of personnel
What’s New In 2016?

Section 7.3 - Design and Development

7.3.6 – Design and Development Verification
 The organization shall document verification plans
 If the intended use requires that the medical
device be connected to, or have an interface with,
other medical device(s), verification shall include
confirmation that the design outputs meet design
inputs when so connected or interfaced
 Verification shall be completed prior to release for use
of the product to the customer
What’s New In 2016?

Section 7.3 - Design and Development

7.3.7 – Design and Development Validation

 The organization shall document validation plans

 Design validation shall be conducted on

representative product

 Validation shall be completed prior to release for use of

the product to the customer
What’s New In 2016?

Section 7.3: Design and Development

*7.3.8 – Design and Development Transfer

 The organization shall document procedures for

transfer of design and development outputs to
manufacturing.

 Results and conclusions of the transfer shall be

recorded (see 4.2.5)

(*New sub-clause)
What’s New In 2016?

Section 7.3 - Design and Development

7.3.9 – Control of Design and Development Changes

 The organization shall document procedures to control design and

development changes. The organization shall determine the
significance of the change to function, performance,
usability, safety and applicable regulatory requirements for
the medical device and its intended use
What’s New In 2016?

Section 7.3 - Design and Development

7.3.9 – Control of Design and Development Changes
(cont’d)

 The review of design and development changes shall

include evaluation of the effect of the changes on
constituent parts and product in process or already
delivered, inputs or outputs of risk management and
product realization processes
What’s New In 2016?

Section 7.3: Design and Development

*7.3.10 – Design and Development Files
 The organization shall maintain a design and
development file for each medical device type or
medical device family

(*New sub-clause)
What’s New In 2016?

Section 7.4 - Purchasing

7.4.1 – Purchasing Process

 The organization shall establish criteria for the evaluation

and selection of suppliers
 The organization shall plan the monitoring and re-
evaluation of suppliers
 Non fulfillment of purchasing requirements shall be
addressed with the supplier proportionate to the risk
associated with the purchased product and compliance
with applicable regulatory requirements
What’s New In 2016?

Section 7.4 – Purchasing

7.4.2 – Purchasing Information

 Purchasing information shall include, as applicable, a

written agreement that the supplier notify the
organization of changes in the purchased product
prior to implementation of any changes that affect
the ability of the purchased product to meet specified
purchase requirements
What’s New In 2016?

Section 7.4 – Purchasing

7.4.3 – Verification of Purchased Product
 The extent of verification activities shall be based on
the supplier evaluation results and proportionate to
the risks associated with the purchased product
 When the organization becomes aware of any
changes to the purchased product, the organization
shall determine whether these changes affect the
product realization process or the medical device
What’s New In 2016?

Section 7.5 - Production & Service Provision

7.5.4 – Servicing Activities

 The organization shall analyze records of servicing

activities carried out by the organization or its
supplier:
a. to determine if the information is to be handled
as a complaint
b. as appropriate, for input to the improvement
process
What’s New In 2016?

Section 7.5 - Production & Service Provision

7.5.6 – Validation of Processes
 The specific approach and activities associated with
software validation and revalidation shall be
proportionate to the risk associated with the use of
the software including the effect on the ability of the
product to conform to specifications
What’s New In 2016?

Section 7.5 - Production & Service Provision

7.5.8 – Identification
 The organization shall identify product status with respect
to monitoring and measurement requirements throughout
product realization
 If required by applicable regulatory requirements, the
organization shall document a system to assign unique
device identification to the medical device
What’s New In 2016?

Section 7.5 - Production & Service Provision

7.5.11 – Preservation of Product
 The organization shall protect product from
alteration, contamination or damage when exposed
to expected conditions and hazards during
processing, storage, handling, and distribution
What’s New In 2016?

Section 8 - Measurement, Analysis & Improvement

8.2.1 – Feedback
 The organization shall document procedures for the feedback
process. This feedback process shall include provisions to
gather data from production as well as post-production
activities
 The information gathered in the feedback process shall serve as
potential input into risk management
What’s New In 2016?

Section 8 -Measurement, Analysis & Improvement

*8.2.2 – Complaint Handling
 The organization shall document procedures for
timely complaint handling in accordance with
applicable regulatory requirements

(*New sub-clause)
What’s New In 2016?

Section 8 - Measurement, Analysis & Improvement

*8.2.3 – Reporting to Regulatory Authorities
 If applicable regulatory requirements require notification
of complaints that meet specified reporting criteria of
adverse events or issuance of advisory notices, the
organization shall document procedures for providing
notification to the appropriate regulatory authorities

(*New sub-clause)
What’s New In 2016?

Section 8 - Measurement, Analysis & Improvement

8.3 – Control of Nonconforming Product

Now contains 4 separate sub-clauses:

1) 8.3.1 – General
2) 8.3.2 – Actions in response to nonconforming
product detected before delivery
3) 8.3.3 - Actions in response to nonconforming
product detected after delivery
4) 8.3.4 – Rework (NOTE: same requirements as 2003 version)
What’s New In 2016?

Section 8 - Measurement, Analysis & Improvement

8.5.2 – Corrective Action

 The organization shall take action to eliminate the cause of

nonconformities in order to prevent recurrence. Any
necessary corrective actions shall be taken without
undue delay
 The organization shall document a procedure to define
requirements for:
 Verifying that the corrective action does not adversely
affect the ability to meet applicable regulatory
requirements or the safety and performance of the
medical device
Summary

A. Regulatory Requirements

B. Competence

C. Design controls

D. Purchasing controls

E. Software validation
Comparison between
ISO 13485:2016 & ISO 9001:2015

ISO 9001:2015 ISO 13485:2016

Structure Follow the HLS with 7 processes Retains 5 processes

Scope Meet customer requirements Meet customer requirements &

regulatory requirements
Focus Continual Improvement to Continuing suitability, adequacy and
enhance customer satisfaction effectiveness of QMS & safety and
performance of the Medical Device
Personnel Retains need for Management Rep

 See Annex B to see the mapping of 9001 to 13485 (and visa versa)
• Use this as a basis for your company gap analysis.

www.NSAIinc.com
Comparison between
ISO 13485:2016 & ISO 9001:2015

Clauses not directly mapped in ISO 9001 are:

 Cleanliness of product
 Installation
 Servicing
 Particular requirements for sterile medical devices
 Particular requirements for validation of processes for
sterilisation & sterile barrier systems
 *New to ISO 13485:2016 – Medical Device File
 ISO 13485:2016
Transition Policy
Current Situation

 ISO 13485:2003
 EN ISO 13485:2012
Regulatory requirements

 ISO 13485:2003
• CMDCAS
• Australia
• Japan
• MDSAP

 EN ISO 13485:2012
• EU
Co-existence period

 ISO 13485:2016, replaces ISO 13485:2003

and incorporates the Technical Corrigendum
ISO13485:2003/Cor. 1:2009
Co-existence period

 ISO 13485:2003 & ISO 13485:2016 will

co-exist for a 3 year period

 Effective March 1st 2018, ISO 13485:2003

certificates will no longer be issued by
NSAI
Co-existence period

 Effective March 1st 2019 all ISO 13485:2003

certificates will become invalid

 Effective until March 1st 2018 any new,

modified or revised ISO 13485:2003 issued
by NSAI will have an expiry date not to
exceed 1st March 2019
Manufacturer’s responsibility

 Carry out a gap analysis between ISO

13485:2003 &ISO 13485:2016
 Update QMS to the requirements of ISO
13485:2016
 Request registration to ISO 13485:2016
from your registrar
Registrar’s responsibility

 Develop a checklist to help the manufacturers

meet compliance to ISO 13485:2016
 Carry out upgrade audits either at the next
surveillance or re-assessment audit
 Two years following publication, new
registrations will be issued only to ISO
13485:2016
 Three years following implementation of ISO
13485:2016, ISO 13485:2003 will be
withdrawn
EN ISO 13485:2016

 Refer to the Official Journal (OJ) for updates

 In the meantime EN ISO 13485:2012

remains valid
Changes to the Regulatory
framework

ARE YOU READY ?

Current situation

 Both regulations are in the final stages of the

legislative procedure and are estimated to finish
sometime in 2016, allowing them to come into
effect by the end of 2016 or early 2017

 Some time will be needed to polish the agreed text

and have it translated into the official EU Languages
Why Change from Directives to
Regulations?

 High profile vigilance cases with hips

 Pelvic floor meshes exposé by British Newspapers

 Discovery of fraud in PIP breast implants using low

quality “industrial grade” silicone oil
Why Change from Directives to
Regulations?

Outcome
More focus on Notified Bodies through the;
 Commission recommendation 2013-473
• Annex I product assessment
• Annex II on QMS assessment
• Annex III Unannounced audits
 Implementing regulation 920/2013 on the designation
and monitoring of Notified Bodies
New Monitoring mechanism of
Notified Bodies
 All Notified Bodies are to be re-designated per the
requirements of 920/2013
 The audit team comprise representatives of
 Food and Veterinary Office (FVO)
 NB’s Competent Authority
 2 other CA’s
 The designation is valid for 5 years unless the NB wants to
extend their scope
 All results available on the NANDO website:
ec.europa.eu/growth/tools-databases/nando
What the FVO found

Summary of audit findings

 Insufficient evidence that staff employed for conformity
assessment activities were appropriately qualified and
experienced for the task
 Thoroughness of NB’s review of manufacturer’s clinical
evaluations
 The sampling and depth of review of technical files for
Class IIA & Class IIB Devices
 The overall documentation and traceability of the
certification process was not always deemed appropriate
Output from FVO

 Some Notified Bodies have been de-designated

 Some Notified Bodies have elected to stop certification
activities due to constraints of the new system
 Some Notified bodies have scope reductions / limitations
to their operation
 Exclusion of medical devices in class III
 Subset of devices within a NANDO designation
 Medical devices including the Machinery Directive to include
active medical devices only
What lies ahead?
Chapter 1 Definitions

Significant changes ahead

 Products currently not classified as medical devices under the
MDD will be included in the MDR
 Accessories will now include devices that specifically or
directly assist another device in its intended purpose
 Custom made excludes mass produced by industrial means
 Inclusion of products containing non-viable human cell or
tissue derivatives
 Importantly non medical devices with a risk profile similar
to medical devices e.g. aesthetic implants, cosmetic laser
products and contact lenses (Annex XV )
Common Specifications (CS)

Where
 No Harmonised Standard exists
 Current standards are not sufficient
 Pertain to safety, performance and risk with a
prominent focus on clinical data
 Applicable in
• Annex 1, safety and performance
• Annex II technical documentation
• Annex XIII, Clinical evaluation and PMCF
• Annex XIV Clinical evaluation
• Annex XV Design requirements
Next steps

Aesthetic
products per
Annex XV

Standalone What do I need Accessories

software? to do?

Custom
made?
Annex XV, Products without an
intended medical purpose
Review
CS

CE mark Identify Develop

devices
per Annex XV technical
docs
Annex XV devices

Update
QMS
Chapter II

• Making available of devices

• Obligations of economic operators

• Reprocessing

• CE Marking

• Free movement
Changes

Responsible
person for QMS
regulatory Requirements
compliance

Changes

Liability Each person in

at all levels, the supply chain
including will have specific
authorised reps regulatory
responsibility
Under Discussion
Product liability
insurance for both
manufacturers and
Authorised Reps

Under
discussion

Reprocessing of single
use devices (art 15)
Next steps

Reprocessing

Items to
Recall Access to
criteria?
review OBL Technical
files

New QMS
requirements?
Next steps

Product
liability
within the
chain

Person
responsible Items to AR contracts
for regulatory
compliance
review

Reporting
obligations of
importers and
distributers
Next steps

Implant cards,
(information to be
provided to the patient
with an implanted
device)

Items to
review

Parts
manufacturers Update DOC,
vs adverse MDR model
events available
Chapter III

Eudamed
 Traceability
 Registration
 Publication of device performance
 UDI
Changes

Summary of safety and clinical performance

 Class 3 & implants

Summary to include
 Intended purpose
 Device indications & contra-indications
 Reference to standards and CS
 Summary of clinical evaluations
 Profile and training of users
Next steps

Manufacturer,
authorised rep,
economic
operator

Apply to the
Prepare for Traceability device and
implementation higher levels of
of EU UDI /UDI packaging for all
devices

Single UDI for

manufacturers,
AR & importers
Chapter V

Classification

 Up classification
• Nanotechnology
• Spinal disk replacements
• Life saving AMD
• Substance based devices
Changes

Conformity assessment
 New Essential safety and performance requirements
 Mandatory tech file structure and content
 Clinical evaluation for all devices (not new)
 Scrutiny procedure for the most complex high risk
medical devices where no CS have been developed
Next steps

Gap analysis of
all approved
devices on the
market

Classification

Review and Adapt new

implement new conformity
classification assessment
requirements where required
Chapter VI

New concepts relating to

 Article 42 relates to following Annex VIII (full QA ) for all
implantables, (with the exception of sutures)
 Clinical evaluation and Clinical investigation processes are
better defined
 Clinical investigations will be required for implantable and
Class 3 devices with few exemptions

Mandatory PMCF & PSUR

(periodic safety update reports)
Chapter VI

High Risk devices and permanent implants

 Summary of clinical evaluation will be publically available
 Provided in layman’s terms
 Use of clinical data form equivalent devices must be
robust, clinically evidenced and scientifically justified
Next steps

Gap analysis
on current
data

Clinical Update clinical

Mandatory
PMCF
evaluations & evaluations in
line with new
investigations requirements

New
requirements for
claiming
equivalence
Next steps

Generate
clinical
evidence

Clinical
evaluation and
PMCF

Implement
new
requirements
Next steps

Perform gap
analysis

Clinical
investigations
(derogation)

Implement
for new and
existing
devices
Chapter VII

PMS
 To become a continuous evaluation and improvement loop
 Linking to continuous reviews of risk management &
 Annual update of public summary of safety and performance
 Clinical evaluation

Vigilance
 New reporting requirements
 Implement trend reporting
Next steps
Implement new plan
for ongoing PMCF &
PMS requirements

Implement Gather PMS

trend PMS/Vigilance data as early
reporting as possible

Implement
new
Vigilance
reporting
criteria
Chapter VIII

Centralised Governance
Development of Common Specifications
 Developed by expert groups
 Focus heavily on clinical data sets and minimum patient
outcomes for specific device categories
Chapter IX

Penalties regime
 Implementation of market funded market surveillance
 Companies need to prepare for this fund
Chapter X

Final provisions
 Transition period not yet fixed
 What happens in the interim?
• It is possible to comply with the new rules during the
transition period
• Need to find a Notified Body that is designated under the
regulation
Final Provisions

Investment required
 People and time

Grandfathering is not an option

 All device must transition
 Appropriate supporting evidence will be required
• Additional clinical evidence, updated technical files
• Declarations of Conformity must be updated
Where to from here?
Questions
&
Answers