In Australia, medical devices are regulated by the Therapeutic Goods Administration (TGA). To gain approval for a medical device technical file in Australia, manufacturers are required to create a Technical File or Technical Documentation, which contains detailed information about the design, manufacturing, and performance of the device. Consulting with regulatory experts or the TGA is advisable to ensure that your Technical File meets all necessary criteria.
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2. Content
What is Technical File?
Medical Device Technical File
(MDR)
Consultant of Technical Files for
Medical Devices
Contact Us
3. 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.
4. 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.
5. Technical files for medical devices shall be prepared by the medical
device manufacturer and the information’s 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.
6. 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?
7. 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.
8. as per the
Medical device technical file shall be prepared
requirement of Annex II and Annex III of MDR 2017 / 745.
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.
9. 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 201
7/745.
10. 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.
11. 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 T
echnical file as per the
requirement of EU-MDR
Identification and classification of the medical device as per
EU MDR
12. Help in selection of conformity route of assessment and
Notified body
Preparation and Review of the technical documents as per
EU MDR.
Help to maintain and update the technical file post
certification.
