The technical documentation consists of Part A and Part B. Part A, provides the details of the elements listed in Annex II of Regulation (EU) 2017/745, and Part B Annexes has the evidence of each of these elements.
The manufacturer has presented this technical documentation in a clear, organized, readily searchable, and unambiguous manner, to be read and understood by the concerned assessment bodies based on the assessment of conformity of the device.
This technical documentation with evidence is presented in the English language only.
It is provided as paginated and fully searchable PDF files to the concerned assessment bodies. File names have been provided to logically reflect the information covered within that part.
This document has covered all the applicable sections in the order specified in Annex II of Regulation (EU) 2017 / 745. It is organized, allowing easy navigation, thereby reducing the overall time for review.
This document is duly signed and inserted as a scanned page in the respective section. All protocols/reports which require approval (as per the legislative requirements & internal procedures and policies), have undergone those requisite approvals and have been submitted with evidence of those approvals (typically through dated and signed reports, signed protocols, or evidence of approval) The issue number and revision history must be mentioned in the file.
The manufacturer intends to affix the CE Mark Logo and apply for assessment bodies to show compliance with Regulation (EU) 2017/745.
The technical documents related to the device in question are ensured to meet the requirements of Regulation (EU) 2017/745. The technical documentation is conducted by Annex II and Annex III of Regulation (EU) 2017/745, following the conformity assessment as per Article 52. The CE marking of conformity will be made by Annex V, and the declaration shall follow Article 19. The relevant harmonized standards and product-specific standards have also been applied.
Role of European Authorized Representative
The European Authorized Representative plays a crucial role in ensuring that medical devices manufactured outside Europe meet MDR/IVDR requirements and CE Marked before the EU market entry. Their responsibilities include compliance verification, documentation maintenance, incident reporting, and market surveillance, making them an essential partner for manufacturers aiming to enter the European market.
- Acts as the main contact point for the EU regulatory authorities and the manufacturer.
- Receives and forwards any information from the EU authorities to the manufacturer, including any issues related to the device’s compliance and safety.
- Assists in reporting serious incidents and field safety corrective actions (FSCA) to the EU authorities.
- Ensures that all required post-market surveillance activities are conducted and documented properly.
- Monitors the market for any adverse events or non-compliance issues related to the device.
- Liaises with the manufacturer to address and rectify any identified issues.
- Registers the medical device with the relevant national Competent Authorities within the EU.
- Ensures that the manufacturer’s name and address, and the details of the authorized representative, are correctly displayed on the device’s labelling and packaging.
Information supplied by the manufacturer.
As per Regulation (EU) 2017/745, Annexure I – General Safety and Performance requirements, Chapter III section 23.1. (d), Instructions for use (IFU) are included in the packaging for every device. Information provided in the Instructions for Use conforms to the requirements in EN ISO 20417:2021. The device includes Instructions for use to explain how to use the product. Appropriate symbols are printed on the Instructions for use as per standard EN ISO 15223-1:2021.General Safety and Performance Requirements
The General Safety and Performance Requirements are the requirements for safety and performance as specified in Annex I of the Regulation (EU) 2017/745. Evidence of conformity for the device has proven to comply with all relevant GSPR PointsDeclaration of Conformity
The requirements for the Declaration of Conformity (DOC) are described in Article 19 and Annex IV of the Regulation (EU) 2017/745. A written statement has been drawn to demonstrate the fulfilment of the EU requirements relating to the device Lens for the CE marking. The DOC fulfils the obligations imposed by Article 19 of Regulation (EU) 2017/745.Shelf-life
The shelf-life is conducted by accelerated and real-time methods as per EN ISO 11979-6, ASTM F1980-16 and ISO 11607-1.Performance and Safety
To show the performance and safety of devices under pre-clinical information, design verification and validation for them to be included in the technical file.
According to EN 62366:2015, usability engineering is a part of the design & development process for the medical device user interface to identify & reduce the possibility of use errors & use-associated risks.
This part of the standard targets only the safety-related part of the usability of medical devices. The device is a single-use implantable device and sterilized product, its lifetime can be ensured through, risk management, sterilization validation, clinical evaluation, and PMS report, and depends upon the patient’s health condition.
Conclusion
By building a technical File as per the standard covering every aspect of a medical device or in vitro diagnostic device, manufacturers can build confidence in notified bodies about device performance and safety via general safety and performance requirements (GSPR). Team I3CGLOBAL Technical Consultants help with MDR/IVDR technical file preparation thus receiving early CE certification from notified bodies. Contact us for more information.
