CE Marking Technical Files
Are you developing a medical device or in vitro diagnostic device with the intent to sell to the European market? Our dedicated Regulatory Affairs team can assist you with compiling a Technical File compliant to either the Medical Devices Regulation (MDR EU) 2017/745 or In Vitro Diagnostic Devices Regulation (IVDR EU) 2017/746, as appropriate to your device. The Technical File is mandatory for all devices regardless of their classification as it’s purpose is to ensure the device meets the requirements outline in the regulation.
What does a medical device technical file include?
Annex II of EU MDR 2017/745 and EU IVDR 2017/746 requires that the technical file is presented in a clear, organised and readily searchable and unambiguous manner. The Technical File structure covers the requirements of Annex II, which includes the following:
- Device Description and Specification
- Declaration of Conformity
- Instructions for Use
- Design and Manufacturing Information
- General Safety and Performance Requirements
- Risk Management
- Verification and Validation Information
- Post Market Surveillance
The structure of the technical file provided by Patient Guard is designed to allow easy navigation of the required documents for our clients and auditors from Notified Bodies or Competent Authorities.
How is the EU Technical File service provided?
The technical file service is designed to be flexible and we adjust our working style to fit with our customers needs. As standard, we will set up a project plan to detail all the requirements for completing the technical file, which is regularly updated. Additionally, we are available for regular meetings/calls for more in depth discussion if required. All documents created by Patient Guard as part of the Technical File service will be tailored to our clients branding guidelines.
Patient Guard’s experienced consultants will provide you with documented proof of your device’s compliance to the regulation through the EU Technical File Service. If you would like to discuss this service with us, then please contact us for more information.