Class I Medical devices – Do you need a Medical Device Technical file?
Class I Medical Devices (Non-Measurable/Non Sterile/Not reusable) - do you need a Medical Device Technical File?
Medical device manufacturers must prepare and maintain a device technical file according to the Regulation EU MDR 2017/745 for any device products placed on the EU market. Nearly 50% of medical devices placed on the market across the world are accounted for Class I Devices. We have summarised the requirements that need to be met during the preparation of technical file for Class I device products which are non-measurable/non-sterile/not reusable.
What is a Technical File as per EU MDR?
A Medical Device Technical File, or technical documentation is an extensive collection of records which comprise all the technical data and information pertaining to a medical device. Technical file provides evidence to regulatory bodies/ Consumers on safety of a medical device & compliance with applicable regulations.
CE marking of Class I:
Class I devices which are not sterile/ non-reusable/non-measuring is not required to present the technical file to notified bodies. Considering the low risk of the devices, manufacturers can issue a self-declaration of conformity with EU regulations and CE mark the product post technical documentation in place.
Summary of technical documentation required:
- Manufacturer name and address, or those of any authorised representatives
- A brief description of the project
- Identification of the product, for example, the product’s serial number
- The name(s) and address(es) of the facilities involved in the design and manufacture of the product
- A statement of the conformity assessment procedure that has been followed
- The EU declaration of conformity
- Label and instructions of use
- A statement of relevant regulations to which the product complies
- Identification of technical standards with which compliance is claimed
- Manufacturing process and materials, testing as applicable
- Risk assessment as applicable
EU Declaration of Conformity (DOC)
An EU declaration of conformity (DoC) is a mandatory document that manufacturer or manufacturer & authorised representative are required to sign to declare that device products comply with the EU requirements. By signing the DoC manufacturer take full responsibility for the product’s compliance with the applicable EU law.
Non - EU Manufacturers
Manufacturers from outside the EU/European Economic Area (EEA) must appoint Authorised Representative (EAR) to keep a copy of the technical documentation and registration in EUDAMED – Actor & Product and any applicable national competent authority notifications.
Documentation Retention
Manufacturers need to keep the documentation available to Competent Authorities for 10 years after the last device has been placed on the market.
Click here to download a template of EU DOC.
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