European Association of Medical Devices Notified Bodies Web Presentation 2021

The European Association of Medical Devices Notified Bodies, represented by Team-NB, aims to facilitate communication with the European Commission, Competent Authorities, and the Industry. They strive to promote technical and ethical standards, actively participate in improving legal frameworks, and contribute to harmonization efforts. The Code of Conduct is mandatory for all Team-NB members, and they are actively involved in interpreting and implementing new regulations to benefit the medical devices sector.

• Medical Devices
• European Association
• Notified Bodies
• Team-NB
• Regulations

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1. The European Association Medical devices Notified Bodies PRESENTATIONON WEB SITE 2021 1 Team-NB Web Presentation 2021

2. Context of TEAM-NB COMMISSION : DG SANTE EMA MDCG Market Surveillance Expert groups EUDAMED IVD VIGILANCE NBCG NBO CEN CENLEC M R A NBTG AESGP, COCIR, EAAR, EHIMA, EuPC, EUROM, EUROM VI, EUROMContact, FIDE, MedTech Europe CPME CAMD Switzerland Canada Australia New Zealand USA Japan ... Health Professionals Authorised Representatives Notified Bodies Manufacturers Notification Accreditation I 27 Competent Authorities National Accreditation Bodies M D R F TEAM-NB representatives 2 Team-NB Web Presentation 2021

3. Team-NB Aims: Represent Notified Bodies Communication with European Commission Competent Authorities Industry Promote technical and ethical standards Participate in improving the legal framework Contribute to harmonization (e.g. training for notified bodies by notified bodies ) Team-NB Web Presentation 2021 3

4. Team-NB Members over the years 35 32 31 29 28 27 26 26 26 26 26 26 Code of Conduct mandatory 25 25 24 24 23 23 22 19 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 Team-NB Web Presentation 2021 4

5. Team-NB MDR / IVDR designation: TEAM-NB Members versus Designated NBs MDR / IVDR Team-NB Members versus Designated NBs 18 18 15 15 Members Designated NBs 5 5 4 4 4 4 2 1 IVDR MDR MDR IVDR MDR IVDR 2019 2020 2021 Team-NB Web Presentation 2021 5

6. Code of Conduct Version 4 Mandatory to sign for TEAM-NB members Version 4.0 approved on October 2019 Alignment with MDR / IVDR requirements Available on website www.team-nb.org 6

7. Interpretation of the new regulations Team-NB established working groups already from April 2016 Classification & Conformity Assessment NB Clinical Vigilance requirements Aim: formulate an analyse of the new regulations and propose to the members Procedures to be put in place To-do lists to be done to submit application for designation and/or wait for implementing acts Help members to be designated Allow harmonisation 6 Team-NB Web Presentation 2021

8. Interpretation of the new regulations Team-NB established working groups from 2016 Aims Help members to be designated Allow harmonization Nando Designation Non-Members 2 Team-NB Members 15 Non-Members 0 Team-NB 4 MDR designation IVDR designation Team-NB Web Presentation 2021 8

9. Implementation of the new regulations MDCG mirror WGs Aims to allow notified bodies members to speak of 1 voice to prepare and participate in the MDCG meetings to write reports distributed to all members to share information to comment on MDCG proposals to write Position Papers (published on Team-NB web site) Team-NB Web Presentation 2021 9

10. Implementation of the new regulations Task Forces Aims to address specific topics of NBs interest Article 117 TCP III - Taiwan Transfer Agreement Standard fees publically available TOC (table of content) to harmonise views practises to write Position Papers (published on Team-NB web site) Team-NB Web Presentation 2021 10

11. Implementation of the new regulations Trainings Aims to help NBs to deal with new MDR / IVDR requirements in their assessment. to achieve a better harmonisation among NBs thanks to the exchanges Team-NB Web Presentation 2021 11

12. Implementation of the new regulations Trainings in 2019 Clinical data: 3 sessions Trainings in 2020 Clinical data: 1 session Technical Documentation: 2 sessions in September + 1 Q4 Risk Management: 2 sessions in December Trainings in 2021 Performance for in vitro diagnostics Software classification Team-NB Web Presentation 2021 12

13. Transition period CE mark after "Entry into Application" Compliance with MDD or AIMD No significant change in design and intended purpose Application of the requirements of the Regulations related to Post-market surveillance, Market surveillance, Vigilance, Registration of economic operators and devices, NB remains in charge of surveillance Contract between Manufacturers and NBs update to be signed to allow surveillance audits 13 Team-NB Web Presentation 2021

14. Regulation tools Commission tools Under the MDCG supervision Common specifications New instrument to be adopted by implementing acts which manufacturers will need to apply Delegated and implementing acts instrument to precise regulation articles 14 Team-NB Web Presentation 2021

15. European databank on MD (EUDAMED) Use of a medical device nomenclature mandatory Data to be uploaded to collate and process information regarding MD SRN single registration number UDI unique device identifier -> traceability aspects of conformity assessment notified bodies certificates clinical investigations vigilance and market surveillance 15 Team-NB Web Presentation 2021

16. Contacts Management: Alexey Shiryaev (Alexey.Shiryaev@dnvgl.com) president Guy Buijzen (guy.buijzen@dekra.com) treasurer Gero Viola(gero.viola@de.tuv.com) secretary Suzanne Halliday (Suzanne.Halliday@bsigroup.com) vice president Sabina Hoekstra-van den Bosch (Sabina.Hoekstra@tuv-sud.nl) vice president Fran oise Schlemmer (schlemmer@team-nb.org) -Director and Secretariat www.team-nb.org 16 Team-NB Web Presentation 2021

17. Members Team-NB Web Presentation 2021 17