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Clinical data now required for
ALL devices, including Class I The new Directive imposes more stringent
requirements as to what constitutes “clinical evidence” and mandates stronger
enforcement by authorities. The definition of “clinical data” is included and
the Essential Requirements includes a requirement for Clinical Evaluation
according to Annex X, which has been significantly amended. We highly recommend
you review the changes to Annex X.
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Records must be retained for 5+
years Records must now be maintained for inspection by the Competent Authorities
for the useful life of the product or 5 years from date of manufacture,
whichever is greater. For implantable devices, records need to be kept for 15
years from the time the last product was manufactured.
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Class I (Sterile and Measuring)
devices may now choose Annex II Class I Sterile and Measuring devices will have
more flexibility to select a route to compliance as they will be given the
option to select a full quality assurance conformity assessment module.
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Outsourced design and
manufacturing must be more closely monitored If the design or manufacturing of a
device is done by a third party, you must demonstrate that you have adequate
controls in place to ensure the continued efficient operation of the supplier’s
quality system.
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Closer inspection of design
documentation Notified Bodies will be required to perform an inspection of
design documentation for a representative sample of devices using industry
standard statistical techniques and commensurate with the risk of the device.
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Appointment of an Authorized
Representative (AR) explicitly noted The AR gets a mandate to act, and be
contacted, in lieu of the manufacturer in terms of meeting the obligations by
the Directives for all classes of devices.
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Software is now clearly defined
as an active medical device. It does not matter whether the software is integral
with the device or is a standalone product. Software validation will also be an
Essential Requirement.
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Custom devices now subject to
post market surveillance Custom devices will now require a post-market
surveillance system that is reportable to Competent Authorities.
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Instructions for Use (IFU) must
now be revision controlled Where appropriate, the new Directive states that the
date of issue or latest revision of the IFU must be clearly indicated.
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Borderline products Whether a
product is classified as a medicinal product or device will now be determined by
the Primary Mode of Action rather than by the Intended Use!
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Definition of central circulatory
system has been expanded Now includes the vessels aortic arch (arcus aortae) and
descending aorta (aorta descendens) to the aortic bifurcation (bifurcatio aortae).
Any devices that come in contact with these vessels will now be considered Class
III.
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Definition of continuous use has
been expanded Now includes situations where a device, upon discontinuation or
removal, is replaced immediately by the same or with an identical device. This
could impact the classification of certain devices.
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European databank Data related to
clinical investigations will now be collected for the European databank and
shared among Competent Authorities. The databank will also include information
on registration, Authorized Representative, certificates and vigilance data. The
data must be submitted in a standardized format, yet to be determined. The
Directive states that the databank must be operational by September 2012.
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Human tissue Devices that
incorporate human tissue, blood or plasma will fall within the scope of
Directive 2001/83/EC and be considered Class III.
