Technical Files for Medical Devices

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Technical Files for Medical Devices
www.mavenprofserv.com
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Content

• What is Technical File?
• Medical Device Technical File (MDR)
• Consultant of Technical Files for Medical
  Devices
• Contact Us

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What is Technical File?
The technical files for medical devices refer to
all the documents that a medical device
manufacturer has to submit to demonstrate that
the product conforms to the applicable and
current medical device regulations.
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Technical files for medical devices shall
include, e.g. a detailed description of the
device and specification, reference to the
previous and similar generation of the device,
design information, pre-clinical testing
information, clinical evaluation, and risk
management of the medical device.
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Technical files for medical devices shall be
prepared by the medical device manufacturer and
the informations in the technical file or
technical file for medical devices must be
presented in a clear, organized, readily
searchable, and unambiguous manner to
demonstrate the safety and performance of the
medical device in question.
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Medical Device Technical File (MDR)
Want to prepare a medical device technical file
as per the requirement of MDR 2017/745? If your
answer is yes, you probably have lots of
questions about the preparation of medical
device technical files such as What shall be
covered in the medical devices technical file?
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Which Annex of -MDR 745/2017 shall be referred
for the preparation of medical device technical
file according to MDR? Who will review and
approve the medical device technical file? We
at Maven Profcon Services LLP, shall give you all
the answers. Medical device technical file shall
be prepared as per the requirement of Annex II
and Annex III of MDR 2017 / 745.
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Medical device technical file shall be prepared
requirement of Annex II and Annex III of MDR 2017
/ 745.
as per the
The technical file shall be submitted to the
notified body or competent authority for review
and approval for CE Certification. It should be
made in the English language or the official
language of an EU member state.
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Under the MDR, the manufacturer shall safely
store the technical documents for 10 years other
than implantable device after the last device
has been placed on the market, and in case of the
implantable device, it should be safely stored
for 15 years and non-EU manufacturer documents
should be available with the Authorized
Representative also. Medical device manufacturers
should be responsible for keeping the technical
file up to date and in compliance with general
safety and performance requirements Annex I,
Annex II, and Annex III of MDR 2017/745.
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Consultant of Technical Files for Medical Devices
Our regulatory consultants in Maven who are
experienced in various fields of Medical Device
Regulations are well versed in taking care of
technical documentation like clinical evaluation,
Benefit-Risk Analysis, validations, design and
development files, shelf life stability study,
usability engineering files, safety and
biological evaluation, and chemical
characteristics evaluation.
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Maven as a developing medical device regulatory
consultancy helps you in establishing your
products in various countries with help of our
experienced regulatory consultants. The below
mentioned activities are taken care by
us Gap analysis of Medical Device Technical file
as per the requirement of EU-MDR Identification
and classification of the medical device as per
EU MDR
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Help in selection of conformity route of assessmen
t and Notified body Preparation and Review of
the technical documents as per EU
MDR. Help to maintain and update the technical fil
e post certification.
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CONTACT US
https//mavenprofserv.com/medical-device-
technical-file// business_at_mavenprofserv.com
enquiry_at_mavenprofserv.com