The Routes To Conformity - Navigating EU Regulation

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The Routes To Conformity
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Overview
Introduction Conformity assessment is depended on
key annexures of the regulations Assessment based
on a QMS and Assessment of Technical Documentation
Assessment based on Type-Examination Assessment
based on Product Conformity Verification
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Introduction
A medical device manufacturer has to follow
Conformity Assessment Procedure before placing
the device on the EU Market. These conformity
assessment procedures are documented in Article
52 of the EU MDR 2017/745 for Medical Devices
Article 48 of EU IVDR 2017/746 for Invitro
Diagnostic Medical Device. There are number
routes listed in this Articles, the manufacturer
has to select the route depending on the Class
and Type of the Device.
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Conformity assessment is depended on key
annexures of the regulations
Annex IX- Conformity Assessment based on a QMS
and on Assessment of Technical Documentation Annex
X- Conformity Assessment based on
Type-Examination Annex XI- Conformity Assessment
based on Product Conformity Verification
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Assessment based on a QMS and Assessment of
Technical Documentation
The manufacturer is supposed to maintain a
Quality Management System and it shall be
subjected to Audit and Surveillance. The
notified body will audit the Quality Management
System to verify its compliance against the
regulatory requirements, this audit will be
conducted at manufacturers premises or on the
premises of the manufacturers suppliers and/or
subcontractors as per the requirement. After
Audit, if the requirements are met, the notified
body shall issue EU quality management system
certificate.
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For Class IIa, Class IIb Class III medical
device Class C Class D IVD Devices,
surveillance audit shall be conducted at least
once in a year and an unannounced audit at least
once in 5 years. During the unannounced audit the
Notified Body shall test adequate sample of the
device from the Market or from the manufacturing
Process and if any non-compliance is found they
shall suspend or withdraw or add Restrictions on
the Certificate. During the assessment of
Technical Documentation as per Annex II Annex
III, the notified body shall also conduct
required test in relation to the device or may
ask the manufacturer to carry those tests. After
the assessment, the Notified body will issue
the EU technical documentation assessment
certificate.
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When any substantial change is planned by the
manufacturer, it is supposed to be informed to
the notified body. The notified body will assess
the change and conduct audit if necessary and a
supplement to the EU QMS certificate EU
Technical documentation assessment certificate
will occur.
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Assessment based on Type-Examination
In this approach the notified body certifies the
device on the basis of its representative sample
production envisaged, its technical documents and
its life cycle processes. To be clear Production
envisaged means the device has not yet arrived at
production phase, it shall be produced in future
on the basis of this representative sample once
it is EU Certified.
The notified body shall be kept available with
the representative sample by the
manufacturer/applicant. As per regulatory
requirement, relevant device tests shall be
carried out by the Notified body or they may ask
the applicant to provide those test results. The
Examination and Assessment of Technical
documentation shall be performed by the Notified
Body and they shall map out a report. EU type
Examination Certificate shall be issued.
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Approval from the Notified Body is required
before changes (which may affect the GSPR or with
the conditions prescribed for use) to the
approved device is planned. A supplement to the
EU Type Examination Certificate shall be issued
after examination of the planned change by the
Notified Body.
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This approach is used to ensure that the device
which is already issued an EU Type Examination
certificate conforms to the TYPE and meet the
regulatory requirement.
Assessment based on Product Conformity
Verification

• There are two possible approaches i.e.,
  Production Quality Assurance and Product
  Verification.
• In Production Quality Assurance, the manufacturer
  shall implement and maintain the Quality
  management system and shall follow the
  surveillance activity. The notified body shall
  issue an EU Quality assurance Certificate if the
  device conforms to the Type described in EU Type
  examination certificate.

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In Product Verification, after examination of
each manufactured device the manufacturer shall
issue EU Declaration of Conformity. Examination
and testing of Each Product shall be carried out
by the Notified body as per the regulatory
requirements. The Notified body shall fix or have
fixed its identification number on each approved
device and shall write down an EU product
verification certificate.
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The Query- Which approach shall be selected
depending on the applicants Requirements?
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