2021 T he E uropean A ssociation M edical devices N otified B odies TeamNB Web Presentation 2021 Context of TEAMNB 2 COMMISSION DG SANTE EMA MDCG M R A Switzerland Canada ID: 919597
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Slide1
1
Presentation
on Web Site2021
T
he European Association Medical devicesNotified Bodies
Team-NB Web Presentation 2021
Slide2Context of TEAM-NB
2
COMMISSION : DG SANTE
EMA
MDCG
M
R
A
Switzerland
Canada
Australia
New
Zealand
USA
Japan
...
I
M
DRF
NBCG
NBTG
NBO
Market
Surveillance
Expert groupsEUDAMEDIVDVIGILANCE
CPME
CAMD
Health
Professionals
27 Competent
Authorities
Notified Bodies
Notification
Accreditation
National
Accreditation
Bodies
AESGP, COCIR, EAAR, EHIMA,
EuPC
, EUROM,
EUROM VI,
EUROMContact
, FIDE,
MedTech
Europe
Manufacturers
Authorised
Representatives
TEAM-NB representatives
CEN
CENLEC
Team-NB Web Presentation 2021
Slide3Team-NB
3Promote
technical and ethical standardsParticipate in improving the legal frameworkContribute to harmonization (e.g. training ‘for notified bodies by notified bodies’)
Aims:
Represent
Notified Bodies
Communication
with
European
Commission
Competent
Authorities
Industry
Team-NB Web Presentation 2021
Slide4Team-NB
4 Members over the years
Team-NB Web Presentation 2021
Slide5Team-NB
5 MDR / IVDR designation: TEAM-NB Members versus Designated NBs
Team-NB Web Presentation 2021
Slide6Code of Conduct Version 4
6 Mandatory to sign for TEAM-NB members Version 4.0 approved on October 2019 Alignment with MDR / IVDR requirementsAvailable on website www.team-nb.org
Slide76
Classification & Conformity Assessment
NB requirements
Clinical
Vigilance
Team-NB
established
working
groups
already
from
April 2016
Aim
:
formulate
an analyse of the new regulations and propose to the membersProcedures to be put in placeTo-do lists…to be done to submit application for designation and/or wait for implementing actsHelp members to be designatedAllow harmonisationInterpretation of the new regulations
Team-NB Web Presentation 2021
Slide8Interpretation of the new regulations
8 Team-NB established working groups from 2016 AimsHelp members to be designatedAllow harmonization
Team-NB Web Presentation 2021
Slide9Implementation of the new regulations
9 MDCG mirror WGs Aimsto allow notified bodies members to speak of 1 voice to prepare and participate in the MDCG meetingsto write reports distributed to all membersto share informationto comment on MDCG proposalsto write Position Papers (published on Team-NB web site)
Team-NB Web Presentation 2021
Slide10Implementation of the new regulations
10 Task Forces Aimsto address specific topics of NBs interestArticle 117TCP III - TaiwanTransfer AgreementStandard fees publically availableTOC (table of content)to write Position Papers (published on Team-NB web site)
to harmonise viewspractises
Team-NB Web Presentation 2021
Slide11Implementation of the new regulations
11 Trainings Aimsto 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
Slide12Implementation of the new regulations
12 Trainings in 2019Clinical data: 3 sessions Trainings in 2020 Clinical data: 1 sessionTechnical Documentation: 2 sessions in September + 1 Q4Risk Management: 2 sessions in DecemberTrainings in 2021Performance for in vitro diagnosticsSoftware classification
Team-NB Web Presentation 2021
Slide13CE mark after "Entry into Application"
Compliance
with MDD or AIMDNo 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 surveillanceContract between
Manufacturers
and
NBs
update to
be
signed
to
allow
surveillance audits
Transition period
13
Team-NB Web Presentation 2021
Slide14Commission tools
Under the MDCG supervisionCommon specificationsNew instrument to be adopted by implementing acts which manufacturers will need to applyDelegated and implementing actsinstrument to precise regulation
articlesRegulation tools
14
Team-NB Web Presentation 2021
Slide15European
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 numberUDI – unique device identifier -> traceabilityaspects of conformity assessment
notified bodies
certificates
clinical investigations
vigilance and
market
surveillance
15
Team-NB Web Presentation 2021
Slide16Management:Alexey Shiryaev (Alexey.Shiryaev@dnvgl.com) – presidentGuy Buijzen (guy.buijzen@dekra.com) – treasurerGero Viola (gero.viola@de.tuv.com) – secretarySuzanne Halliday
(Suzanne.Halliday@bsigroup.com) – vice presidentSabina Hoekstra-van den Bosch (Sabina.Hoekstra@tuv-sud.nl) – vice presidentFrançoise Schlemmer (schlemmer@team-nb.org) -Director and Secretariat www.team-nb.org
16
Contacts
Team-NB Web Presentation 2021
Slide17Members
17
Team-NB Web Presentation 2021