1. Healthcare

Impact with changes and
unannounced audits –
a perspective
Paul Sim – Regulatory Affairs Manager
29th January 2015
Copyright © 2014 BSI. All rights reserved.
RNOH DEC Seminar 29th January 2015 - Paul Sim
What is CE Marking
• is the medical device manufacturers claim that a product meets the essential
requirements of all relevant European Directives and is a legal requirement to place a
device on the market in the European Union
• the three medical devices Directives are:
• Medical Devices Directive – MDD
• Active Implantable Medical Devices Directive – AIMDD
• In Vitro Diagnostic Directive – IVDD
• Where does the CE mark apply?
• 28 Member States of the EU, plus:
• Iceland, Leichtenstein, Norway, Switzerland & Turkey
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RNOH DEC Seminar 29th January 2015 - Paul Sim
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What is a Competent Authority?
• is the body within government of the Member states that transposes the requirements of
the Medical Device Directives into National Law
• is also responsible for designating one of more Notified Bodies to act as independent third
party assessors of the manufacturers compliance
• they undertake audits of Notified Bodies in order to verify compliance
• UK Competent Authority is the MHRA
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RNOH DEC Seminar 29th January 2015 - Paul Sim
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What is the role of a Notified Body?
• To conduct conformity assessment under the relevant EU Directives
• The conformity assessment usually involves an audit of the manufacturers quality
system* and depending upon the particular classification of the device, a review of the
relevant technical documentation provided by the manufacturer in support of the safety
and performance claims for the device.
• Technical documentation is assessed against the essential requirements (Annex 1)
• Issues a CE certificate, based on all the criteria being met
• Professional Integrity, requisite competence in the field of medical devices (NBOG Codes)
• Manufacturers sign a declaration of conformity and affix the CE Mark.
• Manufacturers can choose a Notified Body, obviously ensuring they have the appropriate
competence and expertise
•*
quality system – typically ISO 13485
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RNOH DEC Seminar 29th January 2015 - Paul Sim
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Product Classification
• Based on Risk
• 4 categories
• Eg MDD - Class I, Class IIa, Class Iib, Class III
o
NOTE: Class I is further divided in to two categories Sterile & Measuring
• Examples
• Class I – bandages, wheelchairs
• Class IIa – disposable contact lens, sutures, dental fillings
• Class Iib – complex would dressings for burns, baby incubators, dialysis equipment
• Class III – hip replacements, drug eluting stents, absorbable sutures
• AIMDD are all Class III
• IVDD have similar grouping
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RNOH DEC Seminar 29th January 2015 - Paul Sim
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Copy slides from part presentation by:
Erik Hansson
Deputy Head of Unit
European Commission
DG Health and Consumers
Copyright
Copyright ©
© 2014
2014 BSI.
BSI. All
All rights
rights reserved.
reserved.
RNOH DEC Seminar 29th January 2015 - Paul Sim
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New EU legislation
on Medical Devices
Erik Hansson
Deputy Head of Unit
European Commission
DG Health and Consumers
7
Presentation
 Drivers for change
 Commission proposals
 State of play in negotiations
 What do we do in the meantime?
8
Context
 Medical devices = essential for healthcare
 Medical devices sector = growth & competitiveness
European Union
One of the largest
Some of the
market
biggest companies
Ecosystem of
SMEs / microenterprises 9
EU regulatory framework
- drivers for change
 Three directives transposed into national legislation
based on common EU regulatory principles ("the New
approach")
 From 12 to 33 countries - divergences in application
and shortcomings in coordination
10
EU regulatory framework
- drivers for change (continued)
 Technical and healthcare developments
 Scientific and technological advances,
 More focus on prevention, early diagnosis, self-monitoring and
cost-effectiveness,
 Evolving knowledge and expectations
 Globalisation
 Public expectations following the PIP breast implants
scandal
11
Revision of the legislation (continued)




Obligations of economic operators
Vigilance and market surveillance
Eudamed
Traceability of medical devices
 High priority for European Commission
Proposed transition periods:
 Three years (MD)
 Five years (IVD)
12
Revision of the legislation (continued)
European Commission
Proposes legislation
(Proposals : 26/9/2012)
European Parliament
Proposes amendments
(1st reading vote : 2/4/2014)
Council of the EU
Proposes amendments
(Process ongoing)
Negotiation
13
Example of issue debated:
Notified bodies
 Parliament and Council: good proposals to strengthen the
designation, monitoring and functioning of notified bodies.
 Parliament: separate designation of "Special Notified Bodies"
competent for high-risk devices by the European Medicines
Agency (‘EMA’).
 Commission: need to carefully assess the added value of EMA
involvement, as well as the necessary resources and financing.
14
Example of issue debated:
Reprocessing of single-use medical devices
 Proposals made by the European Parliament:
• All medical devices are considered suitable for reprocessing and
reusable;
• Reprocessor must provide scientific evidence;
• Commission to adopt standards for reprocessing;
• Possibility for Member States to ban the practice on their territory;
 Diverging views between Member States
 Commission: Commission proposal balanced approach
15
What do we do in the meantime?
Plan for immediate actions after PIP scandal
 Objective: strengthen controls on medical devices under the current
regulatory system
 4 pillars:




Functioning of notified bodies (NB)
Market surveillance
Coordination in vigilance and market surveillance
Communication and transparency
16
Plan for immediate actions after PIP scandal
(continued)
 Achievements:
 Re-assessment of qualifications and scope of activities of NBs
 Voluntary and mandatory joint audits of NBs
 2 Commission acts
• Criteria to be met for the designation of NB
• Items to be verified by NB during an audit
 Monthly vigilance teleconferences
17
Plan for immediate actions after PIP scandal
(continued)
 Achievements:
Analysis of trends on incidents
Commission Recommendation on traceability
Dialogue with Member States on registers
Report from Member States on market surveillance
activities
18
Impact of immediate
actions
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RNOH DEC Seminar 29th January 2015 - Paul Sim
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Impact of Immediate Actions
Action
Impact
Re-assessment of qualifications and scope of
activities of NBs
•
•
“Voluntary” Joint Audits of NBs by Designating
Authority, Commission (FVO) plus two other CAs
•
•
•
Monthly Vigilance Teleconferences
Copyright © 2014 BSI. All rights reserved.
•
•
NBs submitted to CAs the CVs of all technical
experts for high risk devices
Reduced scope for some NBs?
NBs and Designating Authorities under
scrutiny
Highlights different approaches in Member
States
Some Pain and Some Gain
Increasing number of COEN requests
More open COEN requests requiring detailed
follow up
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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
15 NB audits to date: 10 NBs to withdraw!
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?
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21
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
A few “issues” to iron out
•
•
•
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Unannounced Audits –
an approach
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RNOH DEC Seminar 29th January 2015 - Paul Sim
23
What happens on the day?
BSI Assessors arrive onsite and present identification (letter and weblink)
Request to speak to allocated contact or the most senior person on site
Explanation of visit within brief opening meeting
Audit team progress swiftly to manufacturing area
Assessment team work together to audit all elements specified in the
Commission Recommendation and identify areas / processes for further
audit as part of the visit
Brief closing meeting, with details of findings where possible
Report will be provided within approximately one week
Follow up of any non-conformities through normal audit processes
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24
What did we learn?
So far all were ready, including small manufacturers
Some surprise at:-
•
•
•
•
•
•
•
The assessment team working together
No detailed assessment plan
Different focus to normal visits. i.e. more on product,
less on supporting QMS processes (No routine coverage
of Management Review, Internal Audit & CAPA etc)
Having a visit so soon!
Feedback indicated a more positive experience than
expected!
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25
Are you ready? Have you?
1. Studied the requirement?
2. Factored additional costs into budgets?
3. Implemented processes and procedures for
receiving visits?
4. Responded to any requests from your NB?
5. Reviewed (or are reviewing) critical
subcontractors & crucial suppliers contracts?
6. Communicated awareness across all staff
and trained appropriate staff?
7. Practised!?
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On the day
1. Ensure a guide(s) assigned
2. Be aware of requirement & assist the auditors,
e.g. to get to manufacturing / specified area
as soon as possible
3. Let them know of any concerns or issues (e.g.
no CE devices in production that day, fire
alarm planned)
4. Think ahead – remember likely need to access
Technical Files / Design Dossiers for devices
5. Feel free to ask questions (will they break for
lunch, approximate time to wrap up etc).
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Thank you for your time
& attention
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RNOH DEC Seminar 29th January 2015 - Paul Sim
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BSI Resources
http://medicaldevices.bsigroup.com/en-GB/ourservices/Unannounced-audits-from-BSI/
•
•
•
•
Commission Recommendation
e-Updates
Webinar Details & Recordings
Frequently Asked Questions
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29
BSI Med Tech Operations
Gert Bos
Head of NB 0535
Neil Adams
Director, Operations and Delivery
Suzie Halliday
Head of Ops and
Training
Gert Bos
Head of Global
Regulatory Affairs
Chris Engel
Process Lead
Ibim Tariah
Americas
Technical Director
Vicky Medley
Head of QMS
Paul Sim
Reg Affairs
Mgr
Stewart Brain
Microbiology
QMS Assessment
Teams Worldwide
Copyright © 2014 BSI. All rights reserved.
John Howlett
Head of Notified
Body 0086
Itoro Udofia
Orthopaedic
and
Dental
Haydar Jaafar
General
Devices
David Adams
Active
Devices
David Francis
AIMD
Ron Rakos
Vascular
Wilfried
Babelotzky
Technical Manager
NB 0535
Sue Spencer
In Vitro
Diagnostic
Devices
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Notified Body 0086 Operations
Team
Leadership
Scheme Managers, Technical Specialists, Operations and Process
Client Services
Notified Body
John Howlett
David Adams, NB Operations
Jennifer Pointeer
Ops & Training
Suzie Halliday
Process Lead: Chris Engel Operational analysis: Meaghan Lloyd, Natalie Birnie
QMS &
Unannounced
Audits
Vicky Medley
Paul Sim; David Freebody; Regional QMS Assessment Teams
Pat Webster
Simon Waters
Matt Hall
GRA
Gert Bos
Americas: Ibim Tariah; Asia Pacific: Liang Qian
Jennifer Pointeer
Orthopaedic
and Dental
Itoro Udofia
Sam Boyer
EMEA: Chris Wylie; Amie Smirthwaite; Lindsay Newcombe; Paul Jenkins; Stephen Curran; Matthew
O’Donnell; Jonathan Favin; Susana Faria; Natasha Bhuiyan; Milad Masjedi; John Hodgkinson
Americas: Hamish Forster; Lori Stayton; Timothy Brown Asia Pacific: Chiaki Sato
Dipu Miah
Iain Crow
Simon Waters
General Devices
Haydar Jaafar
Bryan Emms
EMEA: Monisha Phillips; Satish Champaneri; James Newman; Jennifer Durrant; Neill Bannister;
Jayanth Katta; Peter Bowness; Sophie Tabutin; Tina Amini; Amelia Douglas; Rebecca O'Neill; Julie
Taylor; Serena Russell
Americas: Laurel Macomber; Nick Trilokekar; Katie Harrigan Asia Pacific: Chiaki Sato; Yun Sun
Kevin Armoogum
Susan Dunnett
Jennifer Pointeer
Vascular
Ron Rakos
Sheila Walsh
EMEA: Giovanni Di Rienzo; Sofia Faraasen; Gjalt Bosma; Delphine Corriette
Americas: Maritza Carballo; Jason Mead; Les Trzesniowski; Jaishankar Kutty; Alexandra Jantzen;
Orlando Padilla Asia Pacific: Leo Guo
Joan Jones
Matt Hall
Colin Arnold
Active Devices
David Adams
EMEA: Alan Barker; Sharmila Gardner; Hans-Gerd Evering; Aneela Lala, Stuart Corner; Daniel
Taylor; Richard Tully; Stephen Ward; Varun Sukumaran; Lena Gourmelon; Paula Gomes
Americas: Anna Varlese Asia Pacific: Madana Gopal; Lane Ji; Hideyuki Harano
Sadhu Kolla
Blair Hunter
Nathan Bevis
AIMD
David Francis
EMEA: Den Lane; Maarten Hermens; Lixia Zhou; Mark Adams; Paul Risborough
Americas: Andre Routh; Greg Martin Asia Pacific: Lee Glanzmann
Anna Jasinska
Microbiology
Stewart Brain
Bill Enos
EMEA: Magnus Graham; David Pickard; Anazim Mohd-Radzi; Gillian Cairns
Americas: Dean Bird; Mary Sheehan; Angela O’Brien; Lou Stinson; Michael Douthit
Asia Pacific: Various in regional QMS teams
Pat Webster
IVD
Sue Spencer
EMEA: Ann Goodall; Linda Moon; Anna Sadio; Erica Conway; Elizabeth Harrison
Americas: Stefan Burde Asia Pacific: Yun Sun; Hailey Chu
Matt Hall
Colin Arnold
31
Copyright © 2014 BSI. All rights reserved.
Thank you
Name:
Paul Sim
Title:
Regulatory Affairs Manager, Medical Devices
Address:
Telephone:
Mobile:
Email:
BSI, Kitemark Court, Davy Avenue, Knowlhill, Milton Keynes
MK5 8PP, UK
Use mobile number
+44 (0)7786 701022
[email protected]
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