1. Notified Bodies Association TEAM-NB input to EP Rapporteur in red answers to rapporteurs’ questions
The European Association of Medical device Notified Bodies
Gert Bos – President
Francoise Schlemmer – Managing Director
Corinne Delorme – Secretary 1

2. TEAM-NB Aims: Communication with
European Commission
Competent Authorities
Industry
Promote technical and ethical standards
Participate in improving the legal framework
Contribute to harmonization
Represent Notified Bodies
Team-NB Presentation to EP rapporteur

3. Code of Conduct V3 Mandatory to sign for 30 TEAM-NB members
Available on website
Changes and additions:
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

4. TEAM-NB members work outside EU
US 510K
US - A
Canada
Australia
Japan
Taiwan
Hongkong
South Korea
Saudi Arabia
product
QMS
both
AMTAC UK
in progress x
BSI
DEKRA NL
DGM DK
DQS DE
Intertek
ITC CZ
LGA
LNE-Gmed FR
LRQA
MDC s
MEDCERT
NSAI IR
SGS
TUV Rh
TUV Sud
Team-NB Presentation to EP rapporteur

5. 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.
Are Notified bodies up to their job, do they have the expertise? => a selection of the many notified bodies has shown that notified bodies are capable. Evidence in also working for many other regulatory bodies in the world. Others are preparing to move in that same direction. Many of the 87 will not be able to meet much higher criteria that are needed, but quite a few of our members will. It links into having a scope matching competence as well.
Use of clinical expert mandatory in class III & AIMD reviews for initial certification, for renewal and for intermediate review / line extension where new clinical evidence is provided
Use of a national drug review board / EMA on combination products mandatory, seeking a scientific opinion from one of the competent authorities designated by the Member States or the European Medicines Agency (EMEA) acting particularly through its committee in accordance with Regulation (EC) No 726/2004 (1) on the quality and safety of the substance including the clinical benefit/risk profile of the incorporation of the substance into the device (ER 7.4).
Team-NB Presentation to EP rapporteur

6. 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

7. 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
Team-NB Presentation to EP rapporteur

8. 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
Is the scrutiny procedure sufficient: in our view it would be better if scrutiny supervision is done after CE marking in a non-predictable way of sampling. This way the pressure is on for all high risk product reviews. In reality it would be good to on top of random sampling focus on specific product groups, so all energy is going on analysing this group; this should result in writing detailed guidance and clear expectations on clinical and other evidence needed for such group.
Manufacturers of class III/AIMD to make product summary safety assessment reports publicly available at moment of market introduction, with annual revision for the first 5 years, and every 5 years afterwards.
Member states to issue an annual report on the passive and active market surveillance performed in that year
Commission to issue an annual report summarizing the market surveillance activities of member states, with enhanced focus on joint actions
Team-NB Presentation to EP rapporteur

9. 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
Manufacturers of class III/AIMD to make product summary safety assessment reports publicly available at moment of market introduction, with annual revision for the first 5 years, and every 5 years afterwards.
Member states to issue an annual report on the passive and active market surveillance performed in that year
Commission to issue an annual report summarizing the market surveillance activities of member states, with enhanced focus on joint actions
Team-NB Presentation to EP rapporteur

10. 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
The Metal-on-Metal hip implants showed not to be up to demanded performance years after being introduced into the market. This showcases that effective market surveillance captures such long term safety concerns. If all stakeholders would coordinate their focus on long term implants, we might be able to identify such concerns earlier.
Team-NB Presentation to EP rapporteur

11. 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....
The investigation from the British Medical Journal and the Daily Telegraph on hip implants has revealed weaknesses in the system and has brought to light several unacceptable practices, which help to focus on improvements needed. It was however, not a very balanced investigation, as it singled 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. As such it should be seen as identifying some weak players, rather than being reflective on the performance, integrity and quality of all notified bodies....
Cohen in EP workshop
Indicated SGS and TUV in the case
SGS sales agent in Hungary was approached, who referred to technical staff in SGS UK healthcare as she was unqualified in healthcare matters
No comments from TUV Rh yet
Team-NB Presentation to EP rapporteur

12. 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

13. 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
Is the number of notified bodies adequate? We believe we should not focus on the number but on quality and qualification criteria. When the bar is raised to a very high level, the number of notified bodies will drop. There might be mergers. Others will stop like already 2 stopped this year. The remaining bodies will have enough resource and competence to serve the market, as currently 20% of the NBs certify 80% of the market.
Is the legal form of a NB important? We believe not, but independence and competence should be there. Strong supervision independent of legal form of notified bodies. Reduction on outsourced work. In line perhaps with the IMDRF scheme for multipurpose audits that wants to see only in-house staff used for audits.
Tightening up the monitoring of notified bodies with assessments, audits and better communication is crucial to ensure a consistent level of scrutiny of manufacturers and devices across the EU, likely resulting in safer patient care than a central PMA route.
Team-NB Presentation to EP rapporteur

14. Vision on Revision Risk The unborn child Clinical Investigation
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

15. 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

16. Contacts TEAM-NB: www.team-nb.org
Gert Bos President
Hans Heiner Junker (TUV Sud) Vice president
Guy Buijzen (DEKRA) Assistant vice-president
Aud Løken Eiklidh (PreSafe) Treasurer
Corinne Delorme (LNE/Gmed) Secretary
Françoise Schlemmer Director and Secretariat
Team-NB Presentation to EP rapporteur