The MedTech industry is one of Europe’s most diverse and innovative sectors. But it also operates within one of the most tightly regulated environments worldwide. As it is driven by complex regulatory changes and the quest for innovation, the medical device industry landscape is changing, fast.
A key requirement for bringing any medical device to the European Union (EU) market and being compliant is to make sure that comprehensive technical documentation has been compiled in line with the regulation. For new medical devices this is now governed by the EU Medical Device Regulation 2017/745 (EU MDR).
What is Technical Documentation?
Technical documentation, also known as a technical file, is a comprehensive collection of documents that contains all the technical data and information on the development, safety and performance of a device. This can include details such as the intended use, device description, design, and manufacturing information. In the EU, the term ‘technical file’ is commonly used.
Compiling the Technical Document
Annex II of the EU MDR states that the technical documentation shall be presented in a clear, organised, readily searchable and unambiguous manner, and shall include elements listed within the Annex.
The Annex specifies the information that needs to be presented in the technical documentation, which includes:
- Device Description and Specification, including Variants and Accessories
- Information to be Supplied by the Manufacturer
- Design & Development Information
- General Safety & Performance Requirements
- Benefit-Risk Analysis & Risk Management
- Product Verification & Validation
- Additional information required in specific cases
Main Components of a Technical File
Although we have touched up the contents of a technical file, it is worth going into further detail about some of the main components.
- Risk Management
- Clinical Evaluation
- Post market surveillance
- Post market clinical follow up
- General safety and performance requirements
Risk Management
Risk management plays a crucial role in the medical device product development lifecycle, with a strong emphasis in the EU MDR, being mentioned 243 times! It ensures the reliability of the product, its proper functioning, and the safety of patients, operators, and the environment. The risk management cycle aims to create dependable medical devices by minimising the likelihood of failures.
The general process of risk management under the harmonised standard ISO 14971 should ideally be part of the initial stages of any project, though it has not always been considered. To achieve best practices in medical device development, design control should correlate with risk management. Identifying hazards or hazardous situations early on should be integrated into design controls, user needs, and design inputs.
By evaluating the risks and implementing risk control measures, such as design verification and validation, the risks can be mitigated to an acceptable level. Conducting risk management activities correctly is crucial for ensuring medical device compliance with the correct requirements. Updating risk documentation is essential for maintaining compliance.
Clinical Evaluation
Clinical evaluation is a systematic and planned process to continuously generate, collect, analyse and assess the clinical data pertaining to a device to verify the safety and performance. It includes the in-direct or direct clinical benefits of the device when used as intended by the manufacturer and is expected to identify any relevant clinical data that may impact the benefit risk ratio. It is conducted throughout the life cycle of a medical device, as an ongoing process.
It ensures that the evaluation of safety and performance of the device is based on sufficient clinical evidence for the lifetime the medical device is on the market. This ongoing process enables manufacturers to provide notified bodies and competent authorities with sufficient clinical evidence to demonstrate conformity of the device with the General Safety and Performance requirements.
The clinical evaluation is first performed during the development of a medical device to identify data needed for market access (i.e. CE marking) and it must be actively updated thereafter.
Post Market Surveillance
Post-market surveillance (PMS) encompasses all activities carried out by manufacturers, in cooperation with other economic operators, to establish and maintain a systematic procedure. This procedure proactively collects and reviews experiences gained from devices they place on the market, make available on the market, or put into service. The purpose is to identify any need to immediately apply necessary corrective or preventive actions.
The requirements for PMS vary depending on the classification and risk of the medical device:
Low-risk class I devices: A PMS plan and report need to be generated, but there are no specified timeframes for how often these should be updated.
Higher-risk devices: A more detailed Periodic Safety Update Report (PSUR) is required. For Class II devices, the PSUR must be updated biannually, while for Class III devices, it must be updated annually.
Post Market Clinical Follow up
Post Market Clinical Follow-up (PMCF) is a continuous process in which a manufacturer proactively collects and evaluates clinical data about how their device is used within its intended purpose.
It is important to determine early in the development process whether there is a need to implement a PMCF plan before the medical device is launched.
General Safety & Performance Requirements
The GSPRs are the backbone of how you meet the EU MDR. Annex I outlines the requirements that every medical device must fulfil as part of the GSPRs.
Manufacturers must review each requirement and demonstrate compliance through various means, including harmonised ISO standards, verification and validation, risk management, post-market surveillance, and clinical documentation. If a GSPR is not applicable, the manufacturer must provide a justification for its exclusion.
Regulatory Accreditation
When developing a medical device, it’s important to consider the costs of compliance, which vary depending on the risk classification of the device. Low-risk devices that are self-declared do not require a technical file review. However, medium to high-risk devices must undergo a compliance review by a Notified Body and obtain accreditation before being launched on the EU market. This process can be time-consuming, so careful planning is essential, especially given potential changes in regulations and the availability of Notified Bodies.
The length and depth of the review, as well as associated costs, timeframes, and complexities, will vary depending on the device’s risk classification and other circumstances.
Conclusion
Technical documentation is a comprehensive collection of documents that contains all the technical information/data and a critical component of claiming compliance with the MDR.
Although we have discussed that PMS, GSPR’s, Risk Management, and Clinical Evaluation as separate points, it should be noted that these all encompass important inputs into the Technical Documentation and in demonstrating compliance with the MDR.
By Laura Friedl-Hirst, Managing Director at LFH Regulatory
Laura Friedl-Hirst is the Managing Director & Principal Consultant at LFH Regulatory, the organisation she founded in June 2019 and one that has grown vastly since it was established. Her vision was to create a consultancy and a team of consultants that have a pragmatic approach for navigating companies to their end goals. She is as passionate then as she is now about creating a culture that is open, approachable, and flexible; she also promotes a great work-life balance.
After gaining a BSc (hons) in Medical Biology at The University of Huddersfield, she completed a placement year at DePuy and was introduced to the world of regulatory affairs. Since then, she has gained over 12 years’ extensive industry experience working with varying sized organisations and with a diverse range of medical and in vitro diagnostics. Laura has a breadth of knowledge and expertise that spans over regulatory, quality, clinical and design & development.
