Notified Bodies Associations CAMD Stakeholder meeting – November 2015 – Dublin

1. Notified Bodies AssociationsCAMD Stakeholder meeting – November 2015 – Dublin • The European Association of Medical device Notified Bodies • Kevin Butcher – Team-NB Code of Conduct Board Chairman • Hans-Heiner Junker – NB-MED chair,TEAM-NB Vice-President • Neil Adams – TEAM-NB member (in lieu of Gert Bos) 1

2. Notified Body Key Issues All Notified Bodies to be assessed to new regulation requirements before being able to audit Manufacturers against them Re-notification Notified Bodies brings an increased workload for notifying authorities at start of the transition Assess of forecasted 40 to 50 applications will need smart use of available resources in joint assement team to be timely Planning of designation audits needs to be addressed Designation criteria requires to be written now, so that as soon as consensus is reached designation audits can start. In translation period from consensus to publication [e.g. 1 month or 1 year?] all NB’s should be audited as top up over the existing joint assessment that has recently been completed. After successful audit NB’s may then use the entire transistion period for assessments to MDR & IVDR. Unfair competition and additional burden of Notified Bodies firstly notified should be avoided Future Regulations ~ Re-Notification

3. Notified Body Key IssuesFuture Regulations ~ Re-Notification Team-NB supports the enforcement and focus on clinical data and evaluation. However, all additional measures by other parties should not interfere with the certification process, but rather focus on helping improve the clarity on expectations and requirements. The transfer process (one manufacturer changes the Notified Body) should be revisited. Notified Bodies cannot take over responsibility without reviewing at least as a minimum documented evidence of compliance. Taking over responsibility based on existing certificates where the previous Notified Body was voluntarily or forcibly de-designated or had a scope downgrading could lead to unacceptable risk.

4. Notified Body Key IssuesResources Increased Workload and challenge to attract competent staff Unannounced Audits ~ Approx. 33% more audits/per year with same client base. Increased workload from Commission Implementing Regulation No 920/2013 and Commission Recommendation 2013/473/EU De-Designation of poor performing Notified Bodies requiring remaining Notified Bodies to take on this work There is a lack of available qualified people on the market, and a training period of 6 to 9 months before new auditors are competent to conduct audits (for Technical File reviewers it is much longer). With rising requirements e.g. on competence, training and maintenance of personnel, all organizations that will become a Notified Body need to increase competent staff. This is a process that will take time.

5. Notified Body Key Issues Increased Workload The new In Vitro Diagnostics Regulations is forecasted to have additional requirements which will lead to an increased workload on Notified Bodies . Trends show clearly an increase in terms of applications of new manufacturers and/or in term of applications for new products, also applications for innovative products such as nano-materials, mobile health applications, robot, genetics testing,… These innovative medical devices will be time-consuming reviews. Therefore TEAM NB calls on the legislators to ensure an effective transition period of at least Five years for both MDR and IVDR before the requirements relating to Notified Bodies come into force.

6. Notified Body Key IssuesFuture Regulations ~ Re-Notification ~ Possible Solutions An efficient transition from MDD/AIMD and IVDD Designation to MDR / IVDDR Designation: Competent Authorities complete mandatory joint audits by date of publication of MDR and IVDDR in the OJ NBs who have been through mandatory joint audits will be in a better position to meet the requirements of the MDR and IVDR NB should add MDR / IVDDR related clauses to procedures as needed, rather than draft a parallel quality system They should be Designated for the MDR and IVDDR based on same scope, with staff CVs in support They should send list of procedures amended to include MDR / IVDDR to MHRA for desk top review by Competent Authorities NB will then have procedures and staff in place to be compliant with MDR or IVDDR

7. Notified Body Key IssuesFuture Regulations ~ Re-Notification ~ Possible Solutions NB will not have products that have gone through conformity assessment – just like when Notified Bodies applied for designation initially under MDD or IVDD Competent Authority Designates NB, pending review of representative files at next member state surveillance audit and formal re-designation at end of current mandatory designation period NBs apply for scope extensions using MDR or IVDDR compliant CVs in the normal way When MDD, AIMD and IVDDD become void, NB removes related clauses from procedures

8. Notified Body Key Issues Joint Assessments The joint assessments have identified weaknesses in many Notified Bodies and in some cases led to restrictions of scope, inability to take on new clients and even some de-designations. Moreover some Notified Bodies took the voluntary decision to stop their activities in the medical field.

9. Notified Body Key IssuesCo-operation/Suggestions • MDCG to become an effective forum for decision-making • Include notified bodies in working groups? • Common Specifications [CS] are helpful on top of harmonised standards if all stakeholders can contribute – e.g. Specification minimum aspects for clinical trials for new types of implants i.e. trans-catheter heart valves However, CS’s should not create a parallel world with harmonized standards • Harmonized standards that are replaced by new international and/or European standards should be de-harmonized in the event that the new standards cannot be harmonized because of administrative reasons.

10. Notified Body Key IssuesCo-operation/Suggestions • Qualification requirements for personnel involved in conformity assessment procedures to be described in more detail to ensure level playing field all over Europe • Maintain present co-operation on Vigilance issues but define more visibility of the role of Notified Bodies in relation to their involvement in ongoing reviews.

11. EUDAMED European Databank on Medical Devices (as proposed by the European Commission) Electronic system on Clinical investigations Sponsors (& manufacturers) description of: investigational device, comparator, purpose of CI, status of CI Electronic system on Registration Medical devices / IVDs economic operators, incl. Summary of Safety and Clinical Performance (high risk devices) Electronic system on Market surveillance Measures taken by Member States re. devices presenting a risk to health & safety preventive health protection measures Electronic system on Vigilance Serious incidents & Field safety corrective actions & Field safety notices Electronic system on UDI Device Identifier data elements Electronic system on Certificates Certificates issued by notified bodies & Information on certificates refused suspended reinstated restricted withdrawn NBs need to be able to add their own data and review data on their certificate holders NBs need to be able to verify correctiness of economic operators registrations NBs need to be able to access all UDI data relevant to products they assess NBs need to be able to review vigilance investigations on products they certify NBs need to be able to provide or review periodic safety update reports (PSUR) NBs need to be able to verify all data on studies relating products they certify or are assessing

12. Contacts TEAM-NB: • Gert Bos (BSI) President • Hans Heiner Junker (TUV Sud) vice president • Guy Buijzen (DEKRA) vice-president • Cecilie Gudesen Torp(PreSafe) treasurer • Corinne Delorme (LNE/Gmed) secretary • Kevin Butcher (SGS UK) CoC board chairman • Françoise Schlemmer Director and Secretariat www.team-nb.org Team-NB on CAMD