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A technical file or technical documentation is a mandatory set of documents that provides information on the design, manufacture, and operation of a product (medical device).
It must contain all the details necessary to demonstrate that the product was designed in accordance with requirements and that the product conforms to the relevant applicable EU Directives and Regulations (such as the former Medical Devices Directive (MDD) 93/42/EEC and Active Implantable Medical Devices Directive (AIMDD) 90/385/EEC replaced by the EU Medical Device Regulation (MDR) (Regulation (EU) 2017/745), and the In-vitro Diagnostic Device Directive (IVDD) 98/79/EC repealed by the In-vitro Diagnostic Regulation (IVDR) (Regulation (EU) 2017/746)).
The manufacturer must:
- prepare the technical documentation before placing a product on the market
- ensure the technical documentation is made available to the competent authorities responsible for market surveillance(should they request to see it) as soon as the product is placed on the market
- keep the technical documentation available for the competent authorities for a period of at least 10 years (15 years for implantable devices) after the last device covered by the EU declaration of conformity has been placed on the market
Annex II and III of the EU Medical Device Regulation (MDR) and of the In-vitro Diagnostic Regulation (IVDR) contain an overview of the contents and structure of a technical file, referred to as ‘technical documentation’.
Regulatory requirements do not specify how manufacturers should structure a technical documentation, only that the technical documentation must include:
- Device description (including variants, configuration and accessories), and specifications including a general description of the product, technical specifications, and product/trade name with the relevant UDI.
- Intended use and the information supplied by the manufacturer, including the instructions for use (description and specifications, purpose, warnings – if any, and precautions).
- Labelling (packaging, instructions for use, etc.) with hazard symbols, handling instructions, and manufacture and expiry date.
- Information on the design and manufacture of the device to provide the information on the various design stages of the device, as well as information and specifications on the various manufacturing processes and the various quality control protocols.
- A risk management file. The manufacturer is responsible for identifying all the possible risks the product could pose and determining the applicable essential requirements.
- Verification and validation of the device and, therefore, proof that the device meets the general safety and performance requirements, including pre-clinical and clinical trials data.
- A technical documentation on post-market surveillance which must include the post-market surveillance plan and report.
- Declaration of conformity: The medical device technical file is a mandatory document. In this regard, the last section of the document will have the names and signatures of the manufacturer or authorised representatives declaring that the products comply with all required EU regulatory requirements.
Manufacturers can choose in which language the technical documentation will be prepared. However, the competent authorities may ask to translate the technical documentation depending on the EU country where the product has been placed or will be placed on the market.
The technical documentation (technical file) is not just something that manufacturers have to submit to the competent authorities; it is more a set of documents compiled organically throughout the development process and updated throughout the life cycle of the relevant product.
In brief, technical file is the document that demonstrates that medical devices or IVDs are safe and efficacious for their intended use.