| by
Phil Smart
Higher
risk medical products entering the EU must be marked with CE and
number from a Notified Body. This includes Classes IIa, IIb and
III as well as Class I devices, which are supplied sterile, or which
contain a measuring function.
Here
are some common findings from a Notified Body:
Incomplete technical files and design dossiers to support technical
claims
Lack
of clinical data to support section 14 of Annex I (Note: Clinical
data is required for ALL CE-marked medical devices!)
Inadequate
labeling to meet EU language and symbol requirements. Often design
control does not adequately consider the Essential Requirements.
Lack of evidence that EN556 is complied with for sterility assurance.
Lack of evidence that ISO 14971 has been applied to ensure proper
Risk
Management
throughout the design control and post market surveillance process
Note: With regard to EU directives, compliance with "harmonized
standards" provide a presumption of conformity with applicable
essential requirements. EN ISO 14971:2000, "Application of risk
management to medical devices" has been approved by CEN/CENELEC
in the EU as a "harmonized standard". FDA and AAMI also
advocate use of this standard.)
Vigilance reports not submitted to the Competent
Authorities when necessary (Note: To be submitted to the Notified
Body as well. Refer to MEDDEV 2.12/1 Guidelines)
For smaller companies with initial strides in Europe, the issue
is often that the quality management system is not adequately documented
or implemented to meet MDD/IVDD requirements for full QA or Production
QA, i.e. ISO 13485/13488.
Or, perhaps you are simply faced with regulatory
challenges such as:
Product is not reaching market due to very long approval process.
The design dossier and consultation process for your drug/device
combination (any devices which incorporates a medicinal substance
falls under Class III) has stalled, and you feel you have no influence
over time, costs, dealing with the Competant Authority, etc.
Your Notified Body is VERY slow and VERY expensive. What do you
do?
Solution:
What
is the solution? Contact RA/QA International and
we can discuss.
Possible strategies might include:
On-site training/certification of your people to ensure thorough
understanding of their role in designing and manufacturing CE-marked
product;
Documentation analysis, gap analysis and
corrective actions to ensure a streamlined yet effective quality
management system to comply with ISO 13485: Development and submittal
of technical files and design dossiers, including direct communication
with the Notified Body and Competent Authority
Development, management and monitoring of clinical investigations
to comply with EN 540 and GCP
Internal auditing of your facility to ensure MDD/AIMD/IVDD compliance
Send
an e-mail or give us a call. As practicing Notified Body auditors
RA/QA
International can help you to get on top of European conformity
assessment, to ensure
regulatory compliance, to streamline your systems and resources,
and to bring your
products into the EU as quickly as possible!
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