The Medical Device Directive 93/42/EEC (MDD)
will change per March, 21st 2010 without transition period. The
efforts for the reclassification of total joint replacements such as for hip,
knee and shoulder are just closed, manufactures have to face the new challenge
of the revised medical device directive. Those, who have not yet implemented
the changes, will run out of time and will possibly have to deal with
non-comformance, which immediately puts in question the approval of their
devices.
Two major changes concern the qualification of
equipment and process validation:
Software will be regarded as a medical device
as long as it satisfies the general definition as a medical device. This
concerns any device incorporating software or software as a standalone product.
Hence, software needs to be validated according to the state-of-the-art and
elementary rules of software life cycle, risk management, verification and
validation shall be considered.
The other point concerns
the conformity of the medical device and thus the organisation´s quality
management system. In future notified bodies will have to audit not only the
quality management systems of the manufacture but also those of the suppliers
inclusively the sub-suppliers. As a consequence the entire manufacturing
process of in-house production and outsourced process steps will have to be incorporated
into the manufacture´s quality management system. Processes need to be
validated in same depth and level at the suppliers and even their subsuppliers
as it is done internally. At present outsourced processes were regarded very
often as black boxes and only the process output was subsequently monitored. In
near future notified bodies will bring light into the black boxes and directly audit
suppliers and also sub-suppliers. The audits will not only focus on the part of
the outsourced service but also on the quality management system in general.
Hence, referencing to the supplier´s ISO 13485 certification will not satisfy. Both
systems need to be comparable to each other and at the requirements at the same
level. In most cases the quality system requirements of the manufacturer will
be on a higher level than at the supplier. The challenge will be to get the
suppliers into the boat and establish the same requirements. This is relevant
for any outsourced process i.e. development, production, assembling and quality
control of medical devices.
