CE Marking / Design of Technical files
Medical devices (MD) are specific products that are used at different stages of medical therapy from the diagnosis, throughout the treatment and monitoring. To be placed on the market, medical devices must have the "CE". This mark indicates that the design of the device, its development process and its production were completed in compliance with the European legal requirements. Those essential requirements induce constraints in terms of safety and performance that have to be handled prior to entering the market.
There are three European Directives that specifically apply to medical device manufacturers:
- The Medical Devices Directive (MDD) applies to all general medical devices not covered by the Active Implantable Medical Devices Directive or the In Vitro Diagnostics Directive.
- The Active Implantable Medical Devices Directive (AIMDD) applies to active devices intended to be permanently implanted in humans and to related accessories
- The In Vitro Diagnostics Directive (IVDD) applies to devices and kits used to diagnose the patient medical conditions.
In order to affix the CE mark on a product, the manufacturer shall realize a Technical file describing in detail the design of the product, how it has been validated and how it is manufactured. This file shall compile all necessary documents to demonstrate safety and performance of the product.
Once the Technical File is established, the manufacturer shall, according to the classification of the product, submit it for an independent review to a Notified Body. The latter will, after the review, grants the market approval and authorizes the manufacturer to affix the CE Mark on the product.
medidee is experienced in the realization of such Technical File as well as preparing a Summary Technical File that ease the review process for the Notified Body. We can assist with the realization of all necessary descriptions, validations and formalizations in order to efficiently demonstrate the compliance of your product with the legal requirements.
Our services covers the following areas:
- Realization and/or support in the documentation of your Technical File
- Identification and/or completion of the necessary validation activities
- Independent review of your technical file prior to its submission to the Notified Body
- Implementation of a manufacturing strategy which complies to the applicable regulatory requirements
- Review of the labelling and Instructions for Use
- Develop and implement a risk management processes
- Choice of the Notified Body, classification of your Medical Device
- Choice of the Conformity Assessment route For more information on the CE marking process, please send us a message through our contact form and we will contact you within no time.