Obelis Attends Inauguration of CURAM (Center for Research in Medical Devices)
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Obelis Chief Compliance Officer, Mrs. Sandra Ferretti, participated in the official inauguration of CURAM – Center for Research in Medical Devices, which took place on Monday, the 26th of Septemb [...]

MEDDEV 2.7/1 – new guidelines on clinical evaluations
News

On the 29th of June 2016, the European Commission released a new version of MEDDEV 2.7/1, entitled “Clinical Evaluation: A Guide for Manufacturers and Notified Bodies under Directive 93/42/EEC and [...]

EU to release NEW Medical Device Regulations!
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In June 2016, the European Parliament released the consolidated texts of the new EU Regulation Proposals on Medical Devices and In-Vitro Diagnostics Devices. The texts, published on the European Par [...]

New Medical Devices and In-Vitro Diagnostic Regulations – Status of the Ongoing Discussions
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The approval of the new EU Regulations on Medical Devices and In-Vitro Diagnostics Devices will be postponed to 2016. (more…) [...]

Technical File Services

A Technical File is proof that a medical device complies with the essential safety and health requirements set down by the relevant Directive(s). Technical Files are required for all classes of medical devices – Class I, Is, Im, IIa, IIb, III – and they must hold essential information about the medical device, including photographs and diagrams. A Technical File can be compiled in any of theofficial languages of the EU. However, English is the most commonly used. An up to date electronic or hard copy of the file needs to be kept available in Europe allowing it to be presented to any EU Competent Authorities upon request. Manufacturers based outside the EEA are to make it available at the address of their European Authorized Representative. As part of the CE Marking process, it is also advised that an external expert reviews the Technical File.

Definition

A Technical file (also referred to as Technical Documentation or TF) must be created by the manufacturer prior to having the CE Marking affixed on the product. A Technical file serves as evidence of compliance with the essential safety and health requirements that apply to the product, as listed in the relevant Directive(s).

For medical devices, these essential safety and health requirements are presented in Annex I of the MDD 93/42/EEC.

Content

A Technical File should hold information (photographs and diagrams should be used where appropriate) about the medical device.

Unfortunately, there are no clear rules on a Technical File for a medical device, but several guidance documents do exist to support the manufacturer, including the following:

  • NB-Med/2.5.1/Rec5 (2000)Technical Documentation
  • MDEG-2009-12-01.Guidance notes for manufacturers of Class I Medical Devices
  • NBOG 2009-4.Guidance on NB Tasks of Technical Documentation Assessment on a Representative Basis
  • GHTF/SG1/N063:2011.Summary Technical Documentation for Demonstrating Conformity of the Essential Principles of Safety and Performance of IVD Medical Devices

Language

The file can be in any of the official languages of the EU. However in most cases, manufacturers will have most of, if not all, the Technical File in English. Parts, or even the entire file, may need to be translated into a language understood by anyone who needs to review it – EU Authorities, Notified Bodies, and Authorized Representatives.

Accessibility

A copy of the Technical Documentation for a medical device carrying the CE Marking may be kept in either hard or electronic form, or a combination of both. It must be made available to the EU Competent Authorities at the registered address within the European Economic Area (EEA) upon a duly justified request.

In case of manufacturers established outside the EEA, this request would normally be presented to their European Authorized Representative. No time limit is set for the provision of such a request. Several days are normally acceptable, but it depends on the reason for the request.

Review

As the file is the responsibility of the ‘legal’ manufacturer (whose name appears on the device and is therefore responsible for CE marking), it needs to be reviewed periodically and kept up to date by the manufacturer. Changes must be recorded (keeping the reason and approval for any change) making the file a “controlled” document within the quality system.

Technical Documentation of Class Is/m, Iia, Iib, III medical devices will be inspected by Notified Bodies as part of the CE Certification process that is required for such devices. Additionally, it is always recommended to have a technical file reviewed by an external consultant.

Creation

A Technical File of a medical device should be built up as a story book:

  • Start with the idea & development.
  • Describe what the device does & the condition it treats.
  • Describe the device and how it works.
  • Describe how it is manufactured, including microbiological aspects and sterilization.
  • Describe the specifications and quality checks.
  • Describe the aspects of safety and biocompatibility.
  • Describe how it complies with standards.

 

Obelis Technical File Services

Our Technical File Review/Creation services include, but are not limited to, the following:

  1. Device Classification.
  2. Identification of applicable standards.
  3. Risk management report and gap analysis.
  4. Clinical evidence report and gap analysis.
  5. Safety and biocompatibility.
  6. Guidance on suppliers/subcontractors agreements.
  7. Templates and checklists.
  8. Labeling & Packaging.

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