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 & Documentation
IVDR Technical File Requirements
- Cor-ordinating in providing device design documentation, quality system management documentation, any publications, medical device history file or dossiers, or any other relevant information pertaining to a device’s characteristics and performance.
- Provide in-house reports, and external laboratories report performed from the Manufacturer’s end.
- Coordinate in 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.
Review of IVDR Technical File by Notified Body.
Notified body do technical documentation review either remotely or client obtaining for CE Certificate OR DURING QMS audit. According to Annex VII of EU IVDR, 2017/746 Notified Body must
- Assess technical documentation based on its predefined sampling plan.
- Assess product 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. 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 Technical File
- Provide Technical support and advice to the company for compiling technical files as per regulation.
- 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 problems.
- If required, visit on-site for better understanding and fast-moving of projects.
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