Impact Of New
European Regulations
On Outsourcing Of Medical Devices
During the last two decades,
there has been a steady increase in the outsourcing of medical device
manufacturing to contract manufacturers, service providers, and component
suppliers in European Countries. The medical device approval process in European
Countries has generally been guided by national law where a conformity
assessment is performed by a notified body and the device obtains a CE marking
meaning it can be sold in the European Economic Area.
However, over the past few years
there has also been an increase in the frequency of recalls and increased
scrutiny of the supply chain by regulators. The new European Medical Device
Regulation (EMDR) places additional burden on manufacturers and their suppliers.
Medical device companies will
operate under a stricter regulatory environment in Europe following the approval
of new regulations governing medical devices and in vitro diagnostics by the
Council of the European Union. The Council proposes stricter requirements on
medical device manufacturers, who would be required to:
-
Create a post-market surveillance
system appropriate to a device’s type and risk class
-
Submit periodic safety update
reports (PSURs) akin to pharmaceutical requirements
-
Appoint a person with “requisite
expertise” in the field of medical devices to be responsible for regulatory
compliance
-
Respond more quickly to public
health threats or deaths linked to medical devices
-
Conduct clinical investigations
demonstrating the safety and performance of highest-risk (Class III) devices
-
Consult with an expert panel to
review the manufacturer’s clinical development strategy
-
Submit post-market clinical
follow-up plans and post-market studies of an equivalent device, provided the
device is designated as equivalent by the notified body, or designated as a
modification of a device already marketed by the same manufacturer
-
Notified bodies will undergo a
stricter designation process and increased monitoring by competent authorities,
but they also will be given authority to carry out unannounced factory
inspections
This means trial costs are going
to increase as there would be a need to collect additional clinical data to
demonstrate efficacy and safety of a medical device. The EMDR is also pushing
for greater data transparency meaning companies will need to prepare data in a
traceable and readily available way to respond to any liability issues.
Increased Frequency of Audits
Manufacturers are required to
demonstrate control of suppliers and records of evaluating suppliers. The most
common practice is to categorize suppliers as having either “critical” or
“non-critical” status.
Increased frequency of audits and
audits of more suppliers will stretch the human resources of suppliers and
manufacturers alike. Ultimately, manufacturers will need to consider alternative
solutions to on-site audits, such as remote auditing and sharing audit reports
with other manufacturers.
Labeling and Packaging
If packaging and labeling is
outsourced, then suppliers must invest in new equipment and software to
implement on demand printing.
Implementation of Revised ISO
Standards
In parallel with changes to the
medical device regulations for Europe, the quality system standards (i.e., ISO
9001 and ISO 13485) will also be changing. ISO 9001:2015 is expected to be
released in October 2015, and the DIS2 for ISO 13485:201x was just released for
comment. If these revised standards are harmonized, then contract manufacturers
will be forced to implement these changes in order to meet the CE Marking
requirements.
If contract manufacturers want to
survive during this period of tougher European regulation, contract
manufacturers and component suppliers need to be proactive and get additional
training. Training needs to include general quality system requirements, EMDR.
Suppliers should also consider developing new quality agreements to address the
new regulations.
(Ref:
http://www.meddeviceonline.com
https://www.linkedin.com/pulse
http://www.mddionline.com).
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