The EU CE Marking technical documentation is divided into Part A and Part B as per MDR 2017/745 and IVDR 2017/746. The main section also known as Part A provides details of the elements listed in Annex II of Regulation (EU) 2017/745 and 2017/746, while Part B annexes contain evidence to support claims made in Part A. The manufacturer has presented this technical documentation in an organized, easily searchable, and unambiguous manner for review by the assessment bodies responsible for assessing the device’s conformity.
The technical documentation and supporting evidence must be presented in English with clear page numbers in fully searchable PDF files to the concerned assessment bodies. File names have been chosen to reflect the information covered within each part. The document covers all the applicable sections in the order specified in Annex II of Regulation (EU) 2017/745 /746 and is organized for easy navigation, reducing the overall review time.
The document is signed and inserted as a scanned page in the respective section. All protocols and reports requiring approval, as per legislative requirements and internal procedures, have undergone necessary approvals and are 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 need for a technical file
The technical file must be an assessment by regulatory bodies or the notified body to verify compliance with Regulation (EU) 2017/745 or 2017/746
The MDR/IVDR technical documents for the device in question have been ensured to meet the requirements of Regulation (EU) 2017/745 EU) 2017/746. The technical documentation is carried out by Annex II and Annex III, following the conformity assessment as outlined in Article 52. The CE marking of conformity will be done in compliance with Annex V, and the declaration will follow the guidelines in Article 19. The relevant harmonized standards and product-specific standards have also been applied.
Medical Device CE Marking and EU Representative
The European Authorized Representative Medical device and Invitro diagnostic device manufactured outside Europe must appoint EU Representative before EU market entry. Their EU Rep responsibilities are the following
- Permit to keep contact information in primary information plan and User manuals. The manufacturer’s name and address, and the details of the authorized representative, are correctly displayed on the device’s labelling and packaging.
- Acts as the primary point of contact for EU regulatory authorities and the manufacturer.
- Communication between EU authorities to the manufacturer, including any issues related to the device’s compliance and safety.
- 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.
- Eudamed Registration / EU Registration with the relevant national Competent Authorities within the EU
Risk Management File
The organization has a risk management process, which establishes and maintains a process for identifying hazards associated with medical devices, estimating and evaluating the associated risks by a systematic method, controlling these risks by risk control measures, and monitoring the effectiveness of the controls. All the documents related to the risk management processes should be recorded, which includes the following:
- (a) Risk analysis
- (b) Risk evaluation
- (c) Risk control
- (d) Production and Post-Production Activities
This risk management process is followed throughout the lifecycle of the products. All the documents related to the risk management process for new product design & development process and design changes should be recorded accordingly and maintained as per this procedure.
The risk Management file contains records and other documents created during risk management activities for the medical device throughout its life cycle from initial conception until final decommissioning and disposal. The risk management file provides the information necessary for the review of the risk management process at any phase in the medical device’s life cycle.
It provides traceability for each identified hazard to the risk analysis, the risk evaluation, the implementation, and verification of the risk control measures and the results of the evaluation of the residual risks. It does not physically contain all the records and other documents. However, it contains at least references or pointers to all required documentation, so that it is easy assemble the information referenced in the risk management file in a timely manner.
Risk Analysis Process
Risk analysis is performed for the particular medical device. Implementation of the planned risk analysis activities and the risk analysis results should be recorded in the risk management file.
The risk analysis process consists of the following steps,
- Description of the intended use of medical device and reasonably foreseeable misuse
- Identification of the characteristics of the medical device that are related to safety
- Identification of hazards and hazardous situations associated with the medical device
- Estimation of risks for each hazardous situation
Regulation (EU) 2017/745 on Clinical Evaluation
- The Clinical Evaluation process should be planned, conducted and documented in detail throughout the lifecycle of medical devices and shall be updated if required based on the clinical data obtained from the PMCF plan.
- Before the medical device is placed on the Market and put into service, it should demonstrate conformity with the general safety and performance requirements of the medical devices.
- The clinical risks shall be addressed as part of clinical investigations, clinical evaluation and post-market clinical follow-up and the risk management system should be carefully aligned and updated, if required.
- For class III devices and certain class IIb devices, if required consult an expert panel, before the clinical evaluation and investigation. This should be part of the clinical development plan.
- If the medical device is a class III and implantable device which have been lawfully placed on the market or put into service under Directive 90/385/EEC or Directive 93/42/EEC and for which the clinical evaluation: — is based on sufficient clinical data, and — is in compliance with the relevant product-specific CS for the clinical evaluation of that kind of device, where such a CS is available for such devices clinical Investigation is not required.
- As per MDR Annex I conformity with relevant general safety and performance requirements should be set out under the normal conditions of the intended use of the device, and the evaluation of the undesirable side-effects and the acceptability of the risk-benefit ratio. This should be documented in the clinical evaluation plan.
- The relevant scientific literature currently available relating to the safety, performance, design characteristics and intended purpose of the device, where it is demonstrated that the device subject to clinical evaluation for the intended purpose is equivalent to the device to which the data related and the data adequately demonstrate compliance with the relevant general safety and performance requirements;
- The manufacturer of the equivalent device should have a contract to show full access to the technical documentation on an ongoing basis, to demonstrate the equivalence.
- For products without an intended medical purpose, the clinical data concerning safety, should be from post-market surveillance, PMCF, and, where applicable, specific clinical investigation. Clinical investigations shall be performed for those products unless reliance on existing clinical data from an analogous medical device is duly justified.
- For class III devices and implantable devices, the PMCF evaluation report, and the summary of safety and clinical performance shall be updated at least annually.
- The output of the clinical evaluation report should be updated in Summary of Safety and Clinical Performance (SSCP) and Risk Management.
- The Clinical Evaluation Report shall be updated with the clinical data obtained from the PMCF plan under Part B of Annex XIV, the post-market surveillance plan referred to in Article 84, the Periodic Safety Update Report (PSUR) according to Article 86, and Vigilance as per article 87 and Trend reporting as per article 88.
Conclusion
Manufacturers can but confidence in notified bodies about the efficiency, performance and safety of medical devices or in vitro diagnostic devices by creating a technical file that complies with the standard. This file covers all aspects of the device and addresses the general safety and performance requirements (GSPR).
The technical consultants at Team I3CGLOBAL can assist with MDR/IVDR technical file preparation, helping manufacturers obtain early CE certification from notified bodies. For more information, please feel free to contact us.
