Medical Device Regulation (MDR) – complete documentation is the key to success
By: Marek Pitura
All medical devices should be effective and safe, and the manufacturer is responsible for meeting these requirements. This also applies to software which constitutes a medical device (software as a medical device) or its part. Developing a medical device that meets the criteria requires not only a great deal of technical expertise and knowledge but also compliance with the rules and guidelines described in relevant regulations and standards. Of course, there are many of them. ISO 13485 and the Medical Device Regulation (MDR) are just two examples.
Medical Device Regulation (MDR), ISO 13485 and more
Medical Devices Regulation (MDR) [1] is the overarching regulation in Europe for ensuring the safety and proper performance of medical devices. It sets out the requirements for design, manufacturing, testing, and post-market surveillance of medical devices, including software as a medical device. However, it’s not the only one that matters. There are several crucial standards for medical device development, with the Medical Devices Regulation at the forefront. Other important standards are ISO 13485 (quality management systems), IEC 62304 (medical device software life cycles), and ISO 14971(risk management). These are just a few of the most essential norms that ensure the safety and effectiveness of medical devices.
Amidst the multitude of standards, it is easy to make a mistake
Compliance with the regulations is visible in records and documents showing the performed activities and their results. Their proper maintenance and storage are the responsibility not only of the medical device manufacturer but also of all its subcontractors and suppliers. At the same time, the multitude of standards and the complexity of their provisions can lead to mistakes and unintentional negligence in the preparation of any of the required documents.
List of documents, also for the Medical Device Regulation
We present a list of documents* that we prepare when implementing a medical device development project. Obviously, we tailor the list to the client’s needs each time. We also create relevant documents compliant with the requirements of the Medical Devices Regulation (MDR).
*The order of the documents on the list does not reflect the order of their preparation during project implementation.
Software development
Software Design Plan
How the process of design will look like? Who will be engaged and responsible? What resources do we need? What are the steps?
Software Configuration
Description of the software configuration. How the connected components should communicate? Description and types of protocols, APIs etc.
SOUP documentation
Document presenting a list third party software implemented in the medical device with their the purpose and field of use together with the terms and conditions of the licence.
Software Verification Report
Report on the tests carried out.
Software Release Notes
Document providing information on the version and activities performed during software release.
Software Verification Plan
Description of what the process of testing will look like. What resources do we need? What are the steps? Assignment of ownership and responsibility for each task.
Software Safety Classification
Statements and their underlying reasoning.
Software Development Plan
Description of what the process of development will look like. What resources do we need? How will we conduct and track the work? Assignment of ownership and responsibility for each task.
AI Concept
Document presenting how the AI was implemented in the medical device.
Software Architecture
Description of the software architecture. What are the main components and which are connected?
Indication For Use
Statements and their underlying reasoning.
Maintenance Plan
Description how the process of maintenance will look like. Who will be engaged and responsible? What resources are needed? How the work will be conducted and tracked?
Software Requirements and Specification
Description of the software functionalities and way how there are implemented.
Intended Use
Statements and their underlying reasoning.
Medical devices
Regulatory and Normative Requirements
Document presenting a list of requirements imposed by law for the manufacture and commercialisation of medical devices.
Classification
Statements and their underlying reasoning.
Clinical Evaluation Report
Document presenting the clinical evaluation of the medical device and the actions taken during the evaluation.
Labelling
Document presenting the medical device packaging and information presented to the user before use.
Final Technical File
A collection of all documents relating to a medical device generated during its manufacture.
Post-Market Surveillance Plan
Document presenting planned activities after the medical device has been placed on the market.
User Manual
Document presenting to the user how to operate the medical device.
Declaration of Conformity
Document stating the compliance of the medical device with MDR regulations, signed by an authorised person.
Risk analysis and project management
General Safety and Performance Requirements
Document presenting a list of requirements imposed by MDR.
Risk Management Plan
Description how the process of risk analysis and management will look like. Who will be engaged and responsible? What resources are needed? What are the steps?
Risk Management Report
Document presenting the actions taken during risk management and their results.
Tracebility Matrix
Document presenting the relationships and connections between tasks, requirements, risks and tests.
Change Management Plan
Description how the process of making changes will look like? How the propositions for a change (of scope, timeline, resources) should be discussed and who will approve it?
Literature Search Protocol
Report on the review of technical literature relevant to the scope of the project.
Risk Matrix
Document presenting a list of risks with the mitigating actions taken.
Usability
Usability Engineering Report
Document presenting the actions taken during the work on the usability of the medical device and their results.
Usability Engineering Plan
Description how the process of usability analysis, design and implementation will look like. Who will be engaged and responsible? What resources are needed? What are the steps?
Quality Management
Cybersecurity Concept
Document presenting what cyber security measures have been put in place.
Quality Documents Matrix
Document presenting a list of documents regarding quality and person responsible for preparing it.
Must-have documents for the client
In order to prevent such mistakes, we have prepared, for internal use, a list of documents to prepare when working on a medical device. Of course, we are aware that depending on the given project, the number and content of the individual documents will vary.
That is why before starting to work on a new medical device we always prepare a list with the client that is tailored to their needs and jointly decide who (us or the client) will be responsible for preparing each document.
In addition, we are always happy to provide advice and consultation to the client to the best of our knowledge.
Accelerated certification process
The list of documents developed in this way, according to the needs of the specific project allows us not only to avoid costly mistakes connected with missing documentation, but also to speed up work. We should add that for each of the documents we develop and constantly improve ready-made templates, which speed up and standardize the document preparation process.
This allows us to minimize the risk of missing an important element during the development of a medical device, while at the same time the preparation of documentation in line with the requirements of the Medical Devices Regulation (MDR) becomes more efficient. It does not require lots of time and resources, which translates into lower project implementation costs.
Preparation of documents in line with the Medical Device Regulation (MDR)
The list of documents and ready-made templates is of course not all that Graylight Imaging can offer to its clients. In fact, they are only an introduction to our core competency, which is the development of software that constitutes a medical device or its part in accordance with the Medical Device Regulation (MDR).
For each product, we prepare a full set of documents meeting the requirements of the MDR and submit them to the client upon completion of the works. While preparing the documentation, we draw on the knowledge and experience of our employees. We are also in contact with external experts, specialists in the field of medical device certification, who provide us with advice and support on particularly complex issues. Combining sound preparation with an analysis of the necessary documentation before project launch – based on the list presented and our team’s MDR competences – allows us to provide the client with high-quality documentation. It is a valuable contribution to the certification process of the client’s medical device.