IVDR Technical File

IVDR Technical File & Documentation

In accordance with EU IVDR 2017/746, all producers shall create an IVDR Technical File. The IVD File should contain details on the design, intended use, risk assessment, Clinical and Performance Evaluation, and the path to IVDR compliance. Depending on the IVD classification and conformity assessment method, the technical paperwork may need to be evaluated by a Notified Body (NB) before a CE marking certificate may be granted. The technical file must be made accessible to European Competent Authorities upon request once it has been finished.

IVDR Technical File Requirements

Coordinating the delivery of device design documents, quality system management documentation, publications, medical device history files or dossiers, or any other important information about a device’s features and performance.

Provide in-house findings as well as a report from the manufacturer’s external laboratories.

Through Post Marketing Surveillance, complaint management, and consumer feedback reports, coordinate the collection of information relating to compliance.

If a similar or equivalent device is available in the European Union market, and in which countries, information given by the manufacturer’s marketing team.

Review Of IVDR Technical File By Notified Body

Technical documentation is reviewed by the notified authority either remotely or during the QMS audit, depending on whether the client is getting a CE Certificate. The 2017/746 Notified Body must comply with Annex VII of the EU IVDR.

  • Examine technical documents using the sample plan that has been established.
  • Analyze product technical documentation in accordance with general safety and performance criteria (Annex I).
  • Take into account the needs for preclinical testing and clinical evaluations.
  • Ensure that technical documentation results are categorized correctly and consistently based on a method for assessing compliance with EU MDR and applicable standards.

In some circumstances, kits will be required for testing by an EU Reference Laboratory (EURL) to certify the device’s performance for Class D and other IVD devices. To validate the Manufacturer’s performance claims, the EURL’s scientific opinion shall be requested (Article 48). (5). The device’s certification will require a favourable opinion.

Consultants' Contribution to the Successful Completion Of Technical Files

  • Provide technical assistance and guidance to the firm in order to compile technical files in accordance with regulations.
  • Determine the testing criteria for IVD devices.
  • Assist in the creation of labels with suitable symbols in accordance with EN ISO 15223-1:2016 product standards.
  • Perform a risk assessment in accordance with EN ISO 14971:2019.
  • Suggestions and coordination for biocompatibility test compilation with external Accredited Laboratories are welcome.
  • Conduct a review of the literature and prepare a Performance Evaluation Report (PER).
  • Create processes for post-market monitoring (PMS).
  • As per Article 82 and the MEDDEV guideline paper, develop vigilance, advisory notice, and product recall processes.
  • Troubleshoot and fix technical issues
  • Resolve and troubleshoot technological issues.
  • If necessary, go on-site to have a better knowledge of the project and ensure that it moves quickly.


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