The European Association Medical devices Notified Bodies PRESENTATION

The European Association Medical devices Notified Bodies PRESENTATION 2019 1

Context of TEAM-NB DG GROW EMA CENELEC NB-MED NBRG CPME Health Professionals MDEG NBOG Experts Groups EUDAMED, IVD, CIE Vigilance AMDR, EAAR, COCIR, EUROMContact, Med. Tech Europe, FIDES, EDMA, EUROM UEAPME, CMC Notified Bodies Notification 28 Competent Authorities Manufacturers Accreditation Authorised Representatives logo I M D R F National Accreditation Bodies TEAM-NB representatives 2019 Presentation COEN M R A - Switzerland - Canada - Australia - New Zealand - USA - Japan, … 2

TEAM-NB Aims: v Communication with − European Commission − Competent Authorities − Industry v Promote technical and ethical standards v Participate in improving the legal framework v Contribute to harmonization v Represent Notified Bodies 3 2019 Presentation

TEAM-NB Members 40 35 31 30 25 20 23 24 25 26 26 26 27 32 28 19 15 10 5 Code of Conduct mandatory 35 29 26 25 22 23 24 24 0 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 4 2019 Presentation

Code of Conduct V 3. 4 Mandatory to sign for TEAM-NB members Version 3. 4 approved Available on website www. team-nb. org 5 2019 Presentation

Interpretation of the new regulations Team-NB established working groups already from April 2016 Classification & Conformity Assessment NB requirements Clinical Vigilance Aim: formulate an analyse of the new regulations and propose to the members Procedures to be put in place v To-do lists v … to be done to submit application for designation and/or wait for implementing acts v Help 2019 Presentation members to be designated Allow harmonisation 6

Team-NB: MDR Designation process • Data collected in December 2018 with responses of 22 out of 24 members (knowing that 57 Notified Bodies currently designated for MDD and AIMD) Designation process steps Joint Audit Team opinion 1 Final Designating Authorities report 1 9 Corrective Action Plans submitted to DA 1 On-site Joint Audit 2 Review application by Joint Audit Team Appointment of the Joint Audit Team 0 1 Preliminary Assessment Report by DA Check by Designating Authorities (DA) 0 3 Notified Bodies' application No application yet 2 Not transposed 2 7 2019 Presentation

Team-NB: IVDR Designation process • Data collected in January 2019 with responses of 20 out of 24 members (knowing that 22 Notified Bodies currently designated for IVDD with 10 members) 1 more member intend to apply for IVDR Status of NBs application process 4 Joint Assessment performed 4 Application submitted 2 Application to be submitted in 2019 Application to be submitted later Will not apply for IVDR 1 9 8 2019 Presentation

Designation of notified bodies Notified body designated according to MDR / IVDR before certification of manufacturers Steps v v List of codes published in an implementing act November 2017 Introduction of an application for designation by NBs § On November 26 th, 2017 at the earliest § 80% of the members did it 2017 9 2019 Presentation

Designation of notified bodies Steps v (… to be followed) Joint audit assessment § April 2018: 3 assessments performed . . . v Conformity assessment bodies designated on NANDO ÄTransparency of the designation process (on-going survey) ÄAll codes to be covered v 10 2019 Presentation

Transition period MDR: From May 26 th 2020 to May 26 th 2024 11 2019 Presentation

Transition period IVDR: From May 26 th 2022 to May 26 th 2024 12 2019 Presentation

Transition period CE mark after "Entry into Application" v Compliance with MDD or AIMD v No significant change in design and intended purpose v Application of the requirements of the Regulations related to § Post-market surveillance, Market surveillance, Vigilance, Registration of economic operators and devices, v NB remains in charge of surveillance Contract v 2019 Presentation between Manufacturers and NBs update to be signed to allow surveillance audits 13

Regulation tools Commission tools Under the MDCG supervision v Common specifications Ä New instrument to be adopted by implementing acts which manufacturers will need to apply v Delegated and implementing acts Ä instrument to precise regulation articles 14 2019 Presentation

European databank on MD (EUDAMED) Use of a medical device nomenclature mandatory Data to be uploaded to collate and process information regarding MD v SRN – single registration number v UDI – unique device identifier -> traceability v aspects of conformity assessment v notified bodies v certificates v clinical investigations v vigilance and market surveillance 2019 Presentation 15

Contacts Management: Guy Buijzen (guy. buijzen@dekra. com) – president Kevin Butcher (kevin. butcher@sgs. com) – vice president Corinne Delorme (Corinne. Delorme@lne-gmed. com) – secretary Hans Heiner Junker (hans-heiner. junker@tuev-sued. de) – vice president Alexey Shiryaev (Alexey. Shiryaev@presafe. com) - treasurer Françoise Schlemmer (schlemmer@quasys. com) -Director and Secretariat www. team-nb. org 16 2019 Presentation

Members