IVDR Technical File & Documentation
All manufacturers should compile an IVDR Technical File in compliance with EU IVDR 2017/746. The IVD File should include information about the design, intended use, risk assessment, Clinical and Performance Evaluation, and route to conformity with IVDR requirements. The technical documentation may need to be reviewed by a Notified Body (NB) before a CE marking certificate can be issued, depending on the IVD classification and conformity assessment route. Once completed, the technical file must be made available to European Competent Authorities upon request.
IVDR Technical File Requirements
- Demonstrate how an IVD will be discovered or monitored.
- Explain its role as an IVD in screening, monitoring, diagnosis, prognosis, and prediction.
- What is the precise ailment, condition, or risk factor that it is supposed to identify, characterise, or distinguish?
- Explain how an automated device works.
- Is the IVD qualitative, semi-quantitative, or quantitative in nature?
- What type(s) of the specimen(s) does the IVD require?
- Information on the demographic being tested;
- Is it intended for self-testing, laboratory professionals, or healthcare professionals?
- Provide in-house reports and external laboratories report performed from the Manufacturer’s end.
- Coordinate gathering information related to compliance through Post Marketing Surveillance, complaint handling, and customer feedback reports.
- Information provided by manufacturer marketing team if the similar or equivalent device is available in European Union market and in which countries.
- Demonstrate how an IVD will be discovered or monitored.
Review of IVDR Technical File by Notified Body.
Notified body do technical documentation review remotely or client obtaining for CE Certificate or during an audit. According to Annex VII of EU IVDR, 2017/746 Notified Body must
- Assess technical documentation based on its predefined sampling plan.
- Assess the technical documentation as per general safety and performance requirements, i.e. Annex I.
- Consider requirements related to preclinical testing and clinical evaluations.
- Ensure that technical documentation findings are appropriately and consistently classified based on a procedure to assess compliance with requirements of the EU MDR and relevant standards.
In some cases, for Class D and other IVD devices, kits will be required for testing by an EU Reference Laboratory (EURL) to verify the device’s performance. Will seek the scientific opinion of the EURL will be sought to verify the Manufacturer’s performance claims (Article 48) (5). A favourable opinion will be required for the device’s certification.
Role of Consultants in the successful completion of IVDR Technical File
- Guidance on current regulations, as well as the essential help and guidance for completing CE Certification successfully.
- Identify risk classification
- Identify applicable standards
- Identify testing requirements related to IVD devices.
- Coordinate in designing labels with appropriate symbols as per product requirements referenced from EN ISO 15223-1:2016.
- Conduct a risk assessment per EN ISO 14971:2019.
- Suggest and Coordinate for compilation of biocompatibility test with external Accredited Laboratories.
- Perform a literature review and Performance Evaluation Report (PER).
- Develop post-market surveillance (PMS) procedures.
- Develop Vigilance, Advisory notice, and product recall procedures as per Article 82 and MEDDEV guidance document.
- Troubleshoot and resolve technical queries from the Notified Bodies with the support of the manufacturer.
- If required, visit on-site for better understanding and fast-moving of projects.
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