This article provides guidance on what documents MedTech manufacturers must include in their medical device technical files. The article also shares insights on how a medical device technical file is assessed for MDR compliance.
An efficient digital approach to CE marking medical devices that cut MDR compliance costs and time to market drastically.
What is a technical file?
A technical file represents a set of documents demonstrating a specific product’s compliance with the relevant CE marking legislation. The documentation must indicate the applicable product safety standards and requirements and cover the product’s design, manufacture, and operation.
The technical file of a product must be available for inspection by the market surveillance authorities when the product is placed on the EU market, whatever its geographical origin is. In some cases, the technical documentation may also need to be presented to a Notified Body for review.
Generally speaking, the manufacturer or their appointed authorised representative must keep the technical file for at least ten years from the product’s last date of manufacture. However, according to some CE marking directives and regulations, there is a different duration. For example, the MDD 93/42/EEC specifies a five-year period.
What does a medical device technical file include?
When CE marking a medical device, the manufacturer must present the medical device technical file in a clear, well-organised, readily searchable and explicit manner. According to Annex II of the EU MDR 2017/745, it should include the following elements:
- Device description and specification, including variants and accessories
- Complete labelling and packaging information, including single-unit sales and transport packaging in case of specific management conditions
- Instructions for use in all the languages accepted in the Member States where the medical device is foreseen to be sold.
- Design and manufacturing information, such as design schematics and data about all sites, where design and manufacturing activities are performed.
- Documentation demonstrating compliance with all general safety and performance requirements and all relevant harmonised and non-harmonised standards.
- Benefit-risk analysis and risk management file.
- Product verification and validation report and other relevant documentation.
- Pre-clinical and clinical data, such as test results, clinical evaluation report and PMCF evaluation plan.
- Post-market surveillance plan and report
- Declaration of Conformity
In addition to the technical file, medical device manufacturers must establish, document and implement a proper quality management system and maintain its effectiveness throughout the lifecycle of the devices concerned.
The medical device technical file can be in both paper and electronic format since there are no legal requirements regarding its structure and format. However, the documentation must always be up to date, including the latest modifications to the medical device or amendments in the MDR and any other relevant regulations.
Lastly, according to Articles 38 and 39 of the MDR, all documents part of the medical device technical file must be in a language determined by the Member State concerned. Generally, an official Union language such as English is accepted.
How is a medical device technical file assessed for MDR compliance?
According to Annex IX of the MDR 2017/745, the technical file of medical devices class IIb and class III must be assessed by a Notified Body for compliance with relevant requirements. In this regard, manufacturers must submit an application for assessment to a Notified Body, which must address the design, manufacture and performance of the medical device in question. Consequently, the chosen Notified body must perform the following activities:
- Examine the submitted application
- When required, perform further testing or request additional evidence to be provided to allow assessment of conformity with the relevant MDR requirements.
- Carry out adequate physical or laboratory tests to the medical device or request the manufacturer to carry out such tests.
- Review the clinical evidence presented by the device manufacturer
- In the case where the clinical evidence is based on data from medical devices claimed to be equivalent to the device under assessment, assess the suitability of using such data and document its conclusions on the claimed equivalence.
- Document the outcome of the conformity assessment in the clinical evaluation assessment report.
- Provide the device manufacturer with a report on the technical documentation assessment, including a clinical evaluation assessment report.
- If the medical device conforms to the relevant requirements, issue an EU technical documentation assessment certificate.
Besides the above-stated activities, the Notified body must perform additional procedures for assessing implantable devices, devices containing medical substance or devices incorporating tissues or cells of human or animal origin.
How can we help?
Clever Compliance helps medical device manufacturers meet the MDR requirements and get their devices on the EU market as soon as possible. On one hand, we help our less experienced clients perform a proper regulatory GAP analysis under the MDR, create a valid technical file, register their products with the relevant market authorities and any other part of the medical device CE certification. On the other hand, we offer experienced compliance professionals a compliance management system where they can keep track of their MDR compliance status.
Thus, if you are in need of help with getting your medical device on the EU market, reach out to our team at [email protected]ercompliance.io.