A CE Technical File or Design Dossier is a complete description for a medical device intending to show compliance with EU MDR’s requirements. For a medical device manufacturer, preparing a technical file or design dossier is an essential step in Europe’s CE marketing process.
What does the Technical File/Dossier Contain?
Which Classes of Medical Devices Require Technical Documentation/Dossier?
The Manufacturers of Class I medical device should get the Technical File reviewed by the Notified Body if:
- The device is non-sterile
- It does not have a measuring function.
Technical Documentation Requirements in the Light of EU MDR
Annex II
Description of Device
Device description shall contain the following:
- Product’s name, description, and intended use
- Product identification (this also includes the basic UDI-DI)
- Operational principles and mode of action
- Technical and material specification
- Description of important functional elements
- Any new features
- An overview of the previous generations of the device (if any)
- An overview of devices that are similar to the given device either in the EU or somewhere else.
Information to be supplied by the Manufacturer
This information will tell about:
- The complete set of labels
- Instructions for Use (IFU).
The requirements regarding the information to be supplied by the manufacturer are present in Annex I of Chapter III.
Information Regarding Design & Manufacturing
This will contain:
- The information which will allow understanding of key design elements
- Manufacturing processes’ description
- Validations of manufacturing processes, their monitoring, and final testing of the products
- Complete identification of those suppliers and sub-contractors that have undertaken design or manufacturing processes for the manufacturer.
Requirements of General Safety and Performance
General safety and performance requirements will show conformity to Annex I’s Safety and Performance Requirements. They will also include:
- Identification of Safety and Performance Requirements applicable
- Conformity demonstrating methods
- Applicable standards, typical specifications, or other requirements
- Links to the documents that demonstrate SPR conformity.
Risk Management and Benefit-Risk Analysis
This requirement includes:
- BRA (as required by SPRs 1 and 8)
According to SPR 1 and 8, benefits should be greater than risks, and the risks should be reduced to the most acceptable limit per the current state-of-the-art. - Adopted solutions
- Risk management results which SPR No. 3 requires.
SPR 3 highlights the important clauses of EN ISO 14791.
Verification & Validation of Product
This shall include:
- Pre-clinical and clinical testing
- Clinical Evaluation Report and plan
- The evaluation report and PMCF plan
- Specific validations for devices containing:
- Medicinal substances
- Animal or human tissues
- CMR
- Endocrine-disrupting substances
- Absorbable devices
- Sterile devices
- Devices that have a measuring function
- Devices used in combination.
Annex III
Technical Documentation on Post-Market Surveillance
This includes:
- PMS Plan
- PMS Report
- PSUR
- Minimum Requirements Regarding PMS Plan
- Sources of Information
- Specific Guidance Regarding PMS’s Data Evaluation
- As per Article 83, updating of clinical evaluation, SSCP, and design manufacturing information
- Information for use based upon the output.
New Requirements Regarding Technical Documentation/Dossier
Clinical Investigations & Equivalence
Clinical investigations shall be performed for all Class III as well as implantable devices, but some Class III and implantable devices are exempted from these investigations.
Equivalent devices
- Must have sufficient clinical data
- Their PMCF studies should be present.
These devices are also exempted from Clinical Investigations:
For the devices given in the above illustration
- There must be sufficient clinical data
- They must be CS-compliant (if available).
What does “Sufficient Clinical Data” Mean?
Definition: Sufficient clinical data is based upon its validity in terms of science and clinical evaluation data.
Annex VIII & Device Reclassifications
Annex VIII puts forward the following classification of New Class III devices for the preparation of Technical File/Dossier:
Need to Prepare a Technical File for your Technical File?
As an Asian medical device manufacturer, you may face difficulties in meeting the various EU MDR requirements regarding the preparation of a Technical File/Dossier for your medical device. However, TSQ Asia & Middle East can solve this difficulty of yours with ease. With our expertise in the medical device manufacturing industry, we have helped many clients across Asia, Europe, Middle East, and America. Reach out to us by visiting our website, tsqasia, and get your EU MDR-compliant Technical File/Dossier today!