1. The European Association Medical devices
Notified Bodies
Presentation
2019

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

3. TEAM-NB Communication with Promote technical and ethical standards
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 3
2019 Presentation

4. TEAM-NB
2019 Presentation

5. Code of Conduct V 3.4 Mandatory to sign for TEAM-NB members
Version 3.4 approved
Available on website
2019 Presentation

6. Interpretation of the new regulations
Team-NB established working groups already from April 2016
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
Classification & Conformity Assessment
NB requirements
Clinical
Vigilance 6
2019 Presentation

7. 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) 7
2019 Presentation

8. 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 8
2019 Presentation

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

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

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

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

13. CE mark after "Entry into Application"
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
2019 Presentation

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
2019 Presentation

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
2019 Presentation

16. Contacts www.team-nb.org Management:
Management:
Guy Buijzen – president
Kevin Butcher – vice president
Corinne Delorme – secretary
Hans Heiner Junker – vice president
Alexey Shiryaev - treasurer
Françoise Schlemmer -Director and Secretariat 16
2019 Presentation

17. Members