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CE Marking
and the 2007/47/EC Amendment
Mr. Harshit Thakker
Project Manager
DEKRA Certification B.V. |
If you
export to any of the countries in the European Union
you will certainly be interested in learning about the
CE marking process and some important changes that
have been implemented by the 2007/47/EC Amendment to
the Medical Device Directive (MDD) 93/42/EC. The
amended MDD came into effect on March 21, 2010 and the
changes have impacted all medical device manufacturers
that CE mark their products or plan to do so in
future. This presentation will provide an overview on
CE Marking process and an overview of major changes to
the MDD, including: changes to definitions, the
essential requirements, technical documentation
requirements, classification rules, labeling
requirements, and new requirements for
usability/ergonomics, e-labeling, software and
clinical data. Additionally this presentation will
include discussions on drivers for the changes to the
MDD, things your notified may ask for, and the
approach your notified body may take in verifying
compliance to the amended MDD. |
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Mr. Harshit Thakkar is a Project Manager for DEKRA
Certification B.V. in Chalfont, PA, USA. Mr. Thakkar
is a lead auditor for CE and ISO 13485:2003 audits
(including CMDCAS) and also performs Technical
File and Design Dossier reviews for clients seeking CE
marking for non-active and active medical devices. Mr.
Thakkar holds a Masters Degree in Biomedical
Engineering from University of Southern California,
Los Angeles, USA and Bachelors in Biomedical
Engineering from D. J. Sanghvi College of Engineering,
Mumbai, India. |
|
 Summary
- CE Marking and the 2007/47/EC
Amendment to the Medical Device Directive
Mr. Harshit
Thakker, Project Manager, Dekra Certification B.V.,
Chalfont, PA, USA |
CE
Marking
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CE marking
symbolizes that the natural or legal person
having affixed or
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been responsible for
the affixing of the marking has verified:
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– that the product
conforms to all the European Union provisions
for harmonization
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which apply to that
product
and
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– has subjected the
product to the appropriate conformity evaluation
procedures
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CE Marking -
Medical Devices
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CE Marking Process
and conformity assessment procedures
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Conformity Assessment
Procedures (E.G. - Class IIb device)
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Why Revise the
Medical Device Directive |
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Roman-Age and
Modern-Age Devices |
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Because
- Human
evolution : New thinking
- Device Change - More complex,
higher risk
- Plan, Do, Check, Act
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Status and Timelines of the amendment
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2007/47/EC Amendment
was published on 21st of September 2007.
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Transposition by
Member states before 21st of December 2008.
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Provisions of
2007/47/EC were in force in Member States on 21st
of March 2010.
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No Transition period!
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After 21st of March,
2010: Each device must be in conformity with the
REVISED requirements of the Medical Device
Directive.
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Medical devices
already on the market or put into service can
continue to be used.
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Amended Essential Requirements - Overview
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ER 1: - safe design
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ER 6a: - always
clinical evaluation
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ER 7.1: - biophysical
modeling as option introduced
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ER 7.4: - major
rewording combination products
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ER 7.4: - consultation
on changes
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ER 7.5: - focus on
carcinogenic, mutagenic, toxic for reproduction,
phthalates
(67/548/EEC)
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ER 12.1a - Validation
of software
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ER 13.3 - Authorized
representative, Single use consistency, Date of
last
revision IFU
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