On June 1, 1997, the FDA's new Quality System Regulation (QSR)
was launched. The regulation initially was proposed to go into
effect by June 1, 1998, when medical device companies would be
required to comply with the new system's design control provisions.
After much negotiation, on June 21, 1997, the US and the European
Union (EU) initialed a Mutual Recognition Agreement for medical
device inspections and product reviews - an agreement which is
expected to profoundly affect the way manufacturers work with
regulatory authorities in the US and EU. The Mutual Recognition
Agreement calls for a three-year transition period scheduled to
begin in June 1998. In order for a medical device manufacturer
to meet the EU's Medical Device Directive requirements, companies
are expected to conform to the QSR and the ISO 9000 series standards.
The
EU offers a number of routes to quality assurance certification,
while the FDA offers only one, the QSR , that combines ISO 9001
and ISO 13485 and is equivalent to the EU's "full quality
assurance system." Although the FDA is directly responsible
for approving products and quality systems, it has started to
experiment with third-party quality assessment organizations.
This will move the US closer to the EU system of third-party or
Notified Bodies registration, and result in international harmonization
of standards.
In
the EU, those medical devices that have successfully completed
the relevant conformity assessment procedures specified receive
the CE Mark, enabling marketing throughout the member states of
the EU. Many other countries acknowledge the CE Mark system. "Approval
to market" by the FDA, by contrast, has limited value outside
the US.
JWM
Associates will assist your company in all phases of preparation
for ISO 9001 and ISO 13485 certification. Jeff Morgan, Principal
Consultant, has completed the ANSI-RAB NAP Accredited Lead Auditor
Course with Specific Reference to the FDA-Regulated Industries,
and provides over three decades of medical and industrial experience.
