The European Medical Device Regulation (EU) 2017/745 (MDR) requires medical device manufacturers to provide technical documentation for their products. The technical documentation is a compilation of all relevant documents of a product. It must be kept up to date throughout the entire product life cycle. The technical documentation is the basis for the conformity assessment and thus for the CE marking of a product.
What are the obligations of the manufacturer?
Technical documentation has become even more important because of the MDR. What is new in particular is that the MDR specifies in more detail how technical documentation should be structured.
In addition, the MDR emphasizes the product life cycle. The technical documentation must be kept up to date by the manufacturer and is part of the documentation obligations even after the product has been placed on the market.
With regard to the post-market phase, manufacturers should note that they can make the technical documentation available to the competent authorities for at least 10 years after a device has been placed on the market. For implants, this minimum period is extended to 15 years.
If a competent authority checks whether an assessment by a notified body has been carried out properly, this also includes the technical documentation of a medical device. In addition, a Member State in which a Notified Body is established may require that documentation, including technical documentation, be provided.
The responsible person, newly introduced with the MDR, is responsible for ensuring that the technical documentation and the EU declaration of conformity are prepared and kept up to date. According to the MDR, the manufacturer must set up a system for monitoring the medical device after it has been placed on the market. The data collected there are the basis for the ongoing updating of the technical documentation.
What are the components of technical documentation?
Annex II of the MDR describes which components a technical documentation should contain.
Product description
This section serves to clearly describe and identify the product. It shows the functional elements and mode of action of the product and how it performs as intended. The manufacturer also presents the risk classification of the product and justifies why it is a medical device. Essential contents of this section are:
- basic data (names, designations, UDI)
- intended purpose
- indication and patient group
- general product description
- rationale for medical device
- justification of risk classification
- product characteristics
- product accessories
- product variants
- Product functions (including software)
- Product materials, components, packaging
- product specifications
- previous products
- similar products
In addition, this section contains information on the UDI (Unique Device Identification), the declaration of conformity and the summary report on safety and clinical performance in the case of implantable and class III medical devices.
Manufacturer information
In this section, the manufacturer provides information required by the product user. Essential contents of this section refer to the product labeling and the instructions for use.
Design and manufacture
In this section, the manufacturer describes the phases of product design and development. There is a close link with quality management. Essential contents of this section are:
- Design process (development phases, milestones, bodies involved, etc.)
- manufacturing process (production methods, production sites, quality control, etc.)
- outsourced processes (suppliers, subcontractors, quality control, etc.)
Basic safety and performance requirements
The manufacturer shall systematically state which essential safety and performance requirements from Annex I apply to a medical device and whether they are met. This includes a respective justification if this is not the case. Essential contents of this section are:
- applicability of the essential safety and performance requirements.
- demonstration of conformity with the essential safety and performance requirements and presentation of the methods used
- presentation of the relevant (harmonized) standards, specifications or other rules
- reference to guided documents and records of the demonstration
Benefit-risk analysis and risk management
Manufacturers of medical devices must perform a risk management process. This process is described for medical devices in the ISO 14971 standard. The results or the documents of the risk management flow directly into the technical documentation. These are essentially the risk management plan, the risk analysis incl. control measures and the risk management report, which contains the evaluation of the risk-benefit ratio.
Verification and validation
In this section, the manufacturer documents all analyses, tests, examinations, studies, etc. that serve to demonstrate the conformity of the medical device. In addition to laboratory data, simulation data or results from preclinical investigations, the results of the clinical evaluation and its documentation are included here in particular.
Since medical devices can be very different, there are also different requirements for their verification and validation. Consequently, the corresponding technical documentation differs in terms of structure and content.
The documentation contains not only test results, but also all information on methodology and test set-up as well as study protocols. Depending on the type of medical device and the resulting requirements, test results are primarily documented in the following areas:
- materials used
- biocompatibility
- physical, chemical and microbiological parameters
- electrical safety
- electromagnetic compatibility
- software validation (in conjunction with hardware and software configurations)
- stability and durability
- drug components
- tissues or cells of human or animal origin as components of the medical device
- pharmacology (absorption, distribution, metabolism, excretion, interactions, tolerability and toxicity)
- sterility parameters
- measurement function parameters
- connection configuration parameters for interconnected medical devices
In addition, this section documents the clinical evaluation plan, clinical evaluation report, and if required, the clinical follow-up evaluation report.
What are the components of post-market technical documentation?
According to the MDR, a manufacturer must systematically monitor his medical device after it has been placed on the market. The results flow directly into the technical documentation, which he updates accordingly (Annex III MDR).
Regardless of the risk class of the particular product, manufacturers must prepare a post-market surveillance (PMS) plan based on the following sources of information:
incidents
side effects
trend reports
literature data
feedback and complaints
information on similar medical devices
The MDR requires that the manufacturer proactively and systematically collects the above information and takes corrective action if necessary. At this point, he must also include a post-marketing clinical follow-up (PMCF) plan or justify why this is not required. The results of the clinical follow-up shall be summarized in the PMCF report.
Manufacturers of Class I devices shall prepare a post-market surveillance report (PMS report) on the activities carried out and, where applicable, new findings with regard to the device, which shall be updated as necessary and submitted to the competent authority upon request. For devices in Classes IIa to III, the periodic safety update report (PSUR) is required instead of the PMS report. The update of the PSUR is to be done 2-yearly (Class IIa) or annually (Class IIb and III). The document "MDCG 2022-21 - Guidance on Periodic Safety Update Report (PSUR) according to Regulation (EU) 2017/745" provides detailed explanations on the content and form. Class III and implant manufacturers must also provide the Summary Safety and Clinical Performance Report (SSCP) to the Notified Body for review via the EUDAMED database.
Conclusion
The MDR has increased the requirements for technical documentation. It describes in more detail what information a manufacturer must document and emphasizes its constant updating during the product life cycle.
Annex II and III MDR specify the main chapters of the technical documentation. Recommended in connection with the preparation of technical documentation is the Team-NB position paper "Best Practice Guidance for the Submission of Technical Documentation under Annex II and III of Medical Device Regulation (EU) 2017/745: Information to be supplied by the manufacturer - a collaborative notified body approach". In this you will find many helpful hints on the content of the individual sections as well as on how to submit the technical documentation to your Notified Body. Avoiding known errors should also have a positive impact on processing time.
It is also important to avoid redundant information and an uncoordinated approach by the specialist departments involved. Technical documentation is composed of a large amount of information and is closely linked to quality management. All relevant expertise should be appropriately involved, both communicatively and technically, and produce a document that meets the requirements of the MDR: "clear, organized, easily searchable, and unambiguous." Here, it is recommended to create an overview of the technical documentation, which makes it easier for auditors to quickly find their way around.
