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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Contacts TEAM-NB: www.team-nb.org Gert Bos (gert.bos@bsigroup.com) 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 www.team-nb.org Team-NB Presentation to EP rapporteur