Notified Bodies Association
TEAM-NB input to EP Rapporteur
in red answers to rapporteurs’ questions
• The European Association of Medical device Notified Bodies
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Gert Bos – President
Francoise Schlemmer – Managing Director
Corinne Delorme – Secretary
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TEAM-NB
Aims:
• Communication with
– European Commission
– Competent Authorities
– Industry
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Promote technical and ethical standards
Participate in improving the legal framework
Contribute to harmonization
Represent Notified Bodies
Team-NB Presentation to EP rapporteur
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Code of Conduct V3
• Mandatory to sign for 30
TEAM-NB members
• Available on website
• Changes and additions:
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Extension to IVD
Unannounced visits
Product Verification
Supervisory Structure
Peer assessment
• Signatories in transition
period to come in compliance
Team-NB Presentation to EP rapporteur
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TEAM-NB members work outside EU
US 510K
US - A
Canada
Australia
Japan
Taiwan
Hongkong
South Korea
Saudi Arabia
product
QMS
QMS
both
both
QMS
product
product
product
AMTAC
UK
in progress
BSI
UK
x
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x
DEKRA
NL
x
in progress
x
DGM
DK
x
DQS
DE
in progress
x
Intertek
UK
in progress
x
ITC
CZ
LGA
DE
LNE-Gmed
FR
LRQA
UK
MDC
DE
MEDCERT
DE
NSAI
IR
SGS
UK
TUV Rh
DE
TUV Sud
DE
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in progress
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Team-NB Presentation to EP rapporteur
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What makes a good Notified Body ?
• Ideal NB operation for class III/AIMD/implants
– Selected notified bodies demonstrate that sufficient expertise can be
available in a notified body
– Experienced medical device design engineers from industry, hired and
trained in the NB as own staff, who are the main reviewers, limited additional
external resource allowed (Code of Conduct defines qualification criteria)
– Mandatory (mainly external) clinical experts involved in all class
III/AIMD/implant devices
– Transparent database of all class III/AIMD/implant devices, NB needs to
submit upon start of the review
– Centralized EU oversight body, who sample reviews based on certain
criteria before CE certification and assess the review process and
competence used. NB’s to make available upon request some of their expert
review resources to supplement the competence in the centralized oversight
body.
Team-NB Presentation to EP rapporteur
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What makes a good class III review?
• Concerted review by series of qualified experts
– Qualifications based on product categorization as defined by NBOG
– Qualifications are based on technical or scientific specialisms such as
sterilization, biocompatibility, animal tissue, software, functional safety,
clinical evaluation, electrical safety, packaging, stability, in-vitro mechanical,
chemical or physical verification testing and for IVD the specific technology
such as NAT or ELISA.
– BSc degree or equivalent in the relevant product or medical area for which
the Product Specialist wishes to be qualified...
– 4 Years working experience with practical experience in the medical sector.
– Mainly in house staff
– Use of external clinicians with relevant expertise to assess the product
Team-NB Presentation to EP rapporteur
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What makes a good clinical reviewer?
• List of criteria for clinicians reviewing dossiers defined:
– At least four years of practice in clinical field relevant to device under review
– Actively practicing surgery in field of application for minimum 1 day a week, until
maximally 4 years ago
– Practicing in IMDRF countries, or having practiced there for a minimum of 4 years
– Demonstrated knowledge on reviewing, designing or conducting clinical trials
– Declaration listing what the clinician reviewed before (review CV tracking)
• For external experts: Agreements on responsibilities and
authorities with notified body, including a full CV
• Qualification & scope of review restricted to demonstrated
expertise
• For external experts: Declaration of independence / statement on
not having conflict of interest signed for each review
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What makes supervision good?
• Qualified supervisors (scrutiny):
– National authority personnel responsible for auditing work of Notified Body personnel
responsible for carrying out product related review shall have proven qualifications
equivalent to those Notified Body personnel
– Similar requirement for national authority personnel responsible for auditing work of
Notified Body personnel responsible for carrying out audits
• A central organisation to do unannounced reviews of selected high risk
design dossiers after CE marking
• Performing comparative reviews of CE marked products in the same
category
– maintain early availability benefits for patients
– introduce the needed openness and rigour into the system
– Coordinated with other stakeholders input, such focus would result in detailed product
safety guidance and standards being written
– Use of expert panels (Vascular panel, Orthopedic panel etc), including Notified Body
experts
Team-NB Presentation to EP rapporteur
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What is needed for transparency?
• Remove the ‘in-house exemption’
– on health institutions to be removed so these products become part of
the vigilance reporting scheme which should help identify bad designs
• Improve change reporting:
– Re-order and reword Section 5.5: The applicant shall inform the
Notified Body which issued the EU design-examination certificate of
any planned changes to the approved product, with a supporting case
justifying whether or not the change is significant.
• Build extensive EU database, but more importantly analyse
the data it contains and publish such analysis
• Stakeholder reports publicly available:
– Safety assessment reports on products, market surveillance reports
from Authorities, Overview report Commission
Team-NB Presentation to EP rapporteur
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What is learned from MoM and Changi hips?
• Metal-on-Metal hip implants
– showed not to be up to demanded performance years after being introduced
into the market
– As the problem became visible only after years of implantation, in relatively
low frequency, no regulatory system in the world picked it up pre-market
– showcases that effective market surveillance captures such long term safety
concerns
– Good cooperation between manufacturers, Competent Authorities and
Notified Bodies to investigate the cases – system working at its best....
– If all stakeholders would coordinate their focus on long term implants, we
might be able to identify such concerns earlier
• more coordinated registries
• further defined minimum end-points in PMS data collection
• Active analysis of joint knowledge
Team-NB Presentation to EP rapporteur
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What is learned from MoM and Changi hips?
• Changi hip – BMJ discoveries
– Investigation revealed weaknesses in the system and brought to light
several unacceptable practices, helping to focus on improvements needed
– Not a very balanced investigation, singling out a select group of target
notified bodies and dropped them individually in case the notified body did
not buy the story or suggested to call in their technical experts into the
discussion.
– Identifying some weak notified bodies, rather than being reflective on the
performance, integrity and quality of all notified bodies....
Team-NB Presentation to EP rapporteur
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Vision on Revision
• Reprocessing
– Same rigor to apply to ‘in house’ reprocessing of single use devices
– Disagree with unilateral options per country – distortion of single market
– List of reprocessable single-use devices will secure high level patient safety
A list of single-use devices for critical use which can be
reprocessed, decided by the Commission with oversight from
Member States, will secure a high level of patient safety. An
expert scientific committee, such as the Scientific Committee
on Emerging and Newly Identified Health Risks, should advise
the Commission on this issue, and support regular review of
the list over time to keep it state of art.
Team-NB Presentation to EP rapporteur
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Vision on Revision
• Notified Body Designation, numbers and legal form
– Decisions to be made by audit team, not designating authority
– Commission to rotate peer reviews
– National authority staff doing audits need qualification equivalent to NB staff
– Number or legal form unimportant
– Important are competence, independence and proper supervision
– Utilizing proposed strict criteria will likely result in a serious reduction of
notified bodies or substantial improvement of their quality
=> raising the bar to a very high level
Team-NB Presentation to EP rapporteur
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Vision on Revision
• Classification
– Novelty will be impossible to define
• Risk
– Nothing in life is without risk – amendments needed
• The unborn child
– Suggestion to add protection to embryos
• Clinical Investigation
– Clearer indications from Competent Authorities what they approve when
they approve
– Detail what constitutes interventional study – diverging views
Team-NB Presentation to EP rapporteur
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Vision on Revision
• Clinical Investigation
– Clearer indications from Competent Authorities what they approve when
they approve
– Detail what constitutes interventional study – diverging views
• Vigilance and market surveillance
– Deadline on reporting FSCAs
• Cooperation
– Engage notified body experience
– Clear separation on responsibilities, but also responsibilities of coordination
and exchange of views
Team-NB Presentation to EP rapporteur
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Contacts
TEAM-NB:
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Gert Bos (gert.bos@bsigroup.com)
Hans Heiner Junker (TUV Sud)
Guy Buijzen (DEKRA)
Aud Løken Eiklidh (PreSafe)
Corinne Delorme (LNE/Gmed)
Françoise Schlemmer
President
Vice president
Assistant vice-president
Treasurer
Secretary
Director and Secretariat
www.team-nb.org
Team-NB Presentation to EP rapporteur
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