Introduction
A medical device technical file is a comprehensive collection of documents for Notified Body submission that contains all the technical information and data related to a medical device as per EU MDR or EU IVDR. The medical device technical file includes information on the device, such as device specification, device UDI, manufacturing, testing, clinical evaluation, GSPR, SSCP, PMS, PMCF, PSUR, declaration of conformity and risk management.
A medical device technical file is required in Europe for medical devices and invitro diagnostic devices that are marketed and sold in the European Economic Area (EEA) with CE Logo in primary sales packaging.
MDR / IVDR and EU Representative
The European Authorized Representative is mandatory for medical devices and Invitro diagnostic devices manufactured outside Europe
Manufacturers must keep contact information in the primary information panel and User manuals. The EAR acts as the primary point of contact for EU regulatory authorities and the manufacturer. All 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.
Risk Management File
The organization has a risk management process documentation in place related to medical device / IVD,s in scope covering the following
· Risk analysis
· Risk evaluation
· Risk Control
· Production and Post-Production Activities
The risk analysis process consists of a description of the intended use of the device and reasonably foreseeable misuse, an Identification of the characteristics of the medical device that are related to safety, an Identification of hazards and hazardous situations associated with the medical device
MDR Clinical Evaluation
Technical Files should demonstrate conformity with the medical devices’ general safety and performance requirements. Clinical evaluation is one such important document in the file. 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.
Please ensure that the Clinical Evaluation Report is kept up to date with the clinical data gathered from the PMCF plan under Part B of Annex XIV, the post-market surveillance plan mentioned in Article 84, the Periodic Safety Update Report (PSUR) as per Article 86, and Vigilance as per Article 87, as well as Trend reporting as per Article 88.
The clinical risks must be addressed as part of clinical investigations, clinical evaluation, and post-market clinical follow-up. The risk management system should be carefully aligned and updated as needed. 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.
The process of MDR Clinical Evaluation must be carefully planned, executed, and thoroughly documented throughout the entire lifespan of medical devices. It should also be updated as necessary based on the clinical data obtained from the PMCF plan. 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.
Post Market Surveillance in the CER
PMS plan must be drawn up by Article 84, as stated in Annex III of EU MDR. PMS Plan covers the following:
A proactive and systematic process to collect any information referred to in sec. 6.2.1. The process allows a correct characterisation of the performance of the devices and allows a comparison to be made between the device and similar products available on the market. effective and appropriate methods and processes to assess the collected data; suitable indicators and threshold values have been used in the continuous reassessment of the benefit-risk analysis and of the risk management as referred to in Section 3 of Annex I of MDR; effective and appropriate methods and tools to investigate complaints and analyse market-related experience collected in the field; methods and protocols to manage the incidents subject to the trend report as provided for in Article 88 of MDR, including the methods and protocols to be used to establish any statistically significant increase in the frequency or severity of incidents as well as the observation period;
The methods and protocols to communicate effectively with competent authorities, notified bodies, economic operators and users Scoping of the PMS plan depends on the type of the medical device and factors such as regulatory classification, jurisdictions where the medical device is available, expected device lifetime, usage frequency, intended use, available safety and performance data including the clinical data, life cycle stages about product and technology maturity about the state of the art.
· The objective(s) of the PMS plan depends on the medical device lifecycle, the medical device specifications, the intended use or the application, and the applicable regulatory requirements in different markets.
· Responsibilities and authorities must be defined by the top management. They should define assign and communicate responsibilities and authorities for the PMS activities and should ensure the availability of resources with the independence and competence of PMS activities.
· PMS plan should be prepared by taking into consideration various sources of proactive data mentioned below:
· Each PMS data source should be represented with the following:
· After collecting data sources, a method for collecting the data from these data sources must be established.
· After documenting the methods of data collection, the next step is to develop the data collection protocol. It should consider all the steps required to ensure consistency of the collected data.
· Appropriate methods for data analysis must be selected and should be defined in the PMS plan. There must be considerations for data analysis planning, methods for data analysis and reporting of data analysis.
· A corrective action or preventive action must be taken to rectify or prevent an adverse event from the PMS sources. The management and PMS team head shall coordinate in generating a CAPA number and the corrective action or preventive action to be taken for rectifying the observations due to the device.
· Interfacing of PMS activities with other processes must be established such as to of,
Design & Development, Risk Management, Clinical Evaluation, Regulatory Requirements, Improvement, Marketing & Sales.
· The PMCF requirements of the medical device complying with the applicable regulation should be addressed.
Guidance documents and standards
· EN ISO 13485: 2016 CL 8.2.1 Customer Feedback
· ISO/TR 20416:2020 Medical devices- PMS for Manufacturers
· MEDDEV 2.12-2, Rev 2 Guidelines on Medical Devices. Post Market Clinical Follow-Up Studies Post Market Clinical Follow-up Studies
· MEDDEV 2.7.1, Rev 4, Clinical Evaluation
· Procedure for Periodic Safety Update Report (PSUR)
Conclusion
Manufacturers must appoint experienced candidates with sufficient exposure to the Medical Device Regulation (MDR) general safety and performance requirements. For this reason, it is recommended to appoint a consulting firm with extensive experience and adequate manpower for documentation and coordination with notified bodies. I3CGLOBAL is one such regulatory consulting firm that provides comprehensive services for MDR compliance.