ANSWERED ON THIS PAGE:
- What is a European Technical Documentation?
- Which device classes require Technical Documentation?
- What is the proper format for Technical Documentation?
- How does MDR 2017/745 change EU Technical Documentation requirements?
A CE Marking Technical Documentation (for high-risk Class III devices) is a comprehensive description of your device intended to demonstrate compliance with European regulatory requirements. Compiling your technical documentation is a critical step in Europe's CE Marking process and a requirement for compliance with the Medical Devices Regulation (EU MDR 2017/745) and the In-Vitro Diagnostic Medical Devices Regulation (EU IVDR 2017/746).
These requirements have changed from those under the European Union's previous Directives--the Medical Devices Directive (MDD) 93/42/EEC, the Active Implantable Medical Devices Directive (AIMDD) 90/385/EEC and the In Vitro Diagnostic Medical Devices Directive (IVDD) 98/79/EC. Emergo can assist medical device and IVD manufacturers transition to meet MDR and IVDR requirements for Technical Documentation.
CE Technical Documentation Requirements for medical device companies
Your technical documentation includes detailed information about the design, function, composition, use, claims, and clinical evaluation of your medical device. They are required for all classes of devices (Class I, I Measuring, I Sterile, IIa, IIb, and III), but no two files are the same because the type of device dictates the information included therein.
Unless you manufacture a Class I device that is not provided sterile and does not have a measuring function, your Technical Documentation must be reviewed by a Notified Body. Understanding how to assemble this information and present it for review by Notified Bodies is essential.
Emergo offers CE Technical Documentation compilation services
Emergo specializes in helping medical device and IVD companies achieve CE Marking certification, and we have done so for thousands of devices. Here's a checklist of the services we provide:
- Help you determine exactly which materials need to be compiled.
- Completely review all existing documentation in support of meeting the applicable Essential Requirements of the Directive(s). Evaluate and identify gaps or deficiencies in your documentation.
- Compile your EU Technical Documentation, with internal peer review.
- Determine applicable testing requirements and standards for your device.
- Review your clinical data, compile a Clinical Evaluation Report (CER), and facilitate a Risk Assessment as necessary.
- Review your proposed labeling and Instructions for Use.
Please contact us to learn more about our CE Technical Documentation preparation services for medical devices and IVD manufacturers.
What is a Declaration of Conformity (DoC)?
The DoC is a one-page document that "declares" your device is compliant with the applicable Regulation (MDR or IVDR). It is a legally binding document. The DoC is prepared and signed as the last step in the regulatory process.
How is Technical Documentation formatted?
Most Technical Documentation follows Summary TEchnical Document (STED), a harmonized format for submitting information for regulatory approval of devices. The format was created by the former Global Harmonization Task Force (GHTF), now known as the International Medical Device Regulators Forum (IMDRF). However, some NBs publish extensive documents describing their position on content and formatting. Emergo can format your Technical Documentation to STED or your Notified Body requirements, as needed.
How does Europe's new Medical Device Regulation (MDR 2017/745) change technical documentation requirements, contents, and formatting?
The MDR came into effect in mid-2021. With new requirements for clinical data and risk assessment, and an expanded product scope, the MDR requires that Technical Documentation will need to be more detailed and robust to demonstrate compliance. To learn more about the MDR 2017/745 changes, download our complete MDR white paper.