The European Medical Device Regulation (EU) 2017/745 (MDR) requires medical device manufacturers to provide a technical documentation for their products. The technical documentation is a compilation of all relevant documents for 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 Manufacturer’s Obligations?
- What Are the Components of Technical Documentation?
- What Are the Components of a Technical Documentation After it Has Been Placed on the Market?
What Are the Manufacturer’s Obligations?
The MDR has made the technical documentation even more important. What is particularly new is that the MDR specifies in more detail how the 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 it has been placed on the market.
About the post-market phase, manufacturers should ensure that they can make the technical documentation available to the competent authorities for at least 10 years after a product has been placed on the market. In the case of 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 correctly, this also includes the technical documentation of a medical device. In addition, a member state in which a notified body is established, can request that documents, including technical documentation, be made available.
The new “person responsible for regulatory compliance” being introduced with the MDR takes care for ensuring that the technical documentation and the EU declaration of conformity are created 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 (post-market surveillance, PMS). 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:
This section is used to clearly describe and identify the product. It shows which functional elements and mode of action the product has and how it provides the intended purpose. The manufacturer also presents the risk classification of the product and justifies why it is a medical device. The main contents of this section are:
- basic data (names, designations, UDI)
- intended purpose
- indication and patient group
- general product description
- justification for a medical device
- justification of the risk classification
- novel features
- functional elements (including software)
- technical specifications
- previous devices
- similar devices
This section also contains information on the UDI (Unique Device Identification), the declaration of conformity and the brief report on safety and clinical performance in the case of implantable and class III medical devices.
In this section, the manufacturer provides information that the product user needs. The main content of this section relates 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 connection with the quality management. The main contents of this section are:
- design process (development phases, milestones, bodies involved, etc.)
- manufacturing process (production process, production facilities, quality control, etc.)
- outsourced processes (suppliers, subcontractors, quality control, etc.)
General Safety and Performance Requirements
The manufacturer systematically shows which general safety and performance requirements from Appendix I apply to the medical device and whether these are complied with. This includes a respective reason if this is not the case. The main contents of this section are:
- applicability of the general safety and performance requirements
- proof of conformity with the general safety and performance requirements and presentation of the methods
- presentation of the relevant (harmonized) standards, specifications or other rules
- reference to controlled documents and records of evidence
Risk-Benefit Analysis and Risk Management
Medical device manufacturers must implement a risk management system. The corresponding processes are described for medical devices in the ISO 14971 standard. The results or the documents of the risk management are part of the technical documentation. These are essentially the risk management plan, the risk analysis including control measures and the risk management report, which contains the assessment of the risk-benefit ratio.
Verification and Validation
In this section, the manufacturer documents all analyzes, tests, examinations, studies, etc., which serve to prove the conformity of the medical device. In addition to laboratory data, simulation data or results from pre-clinical examinations, the results of the clinical evaluation and their documentation are particularly included.
Since medical devices can be very different, there are also different requirements for their verification and validation. As a result, the corresponding technical documentation differs in terms of structure and content.
The documentation does not only contain test results, but also all information on the methodology and test setup as well as study protocols. Depending on the type of medical device and the resulting requirements, test results in the following areas are documented:
- materials used
- physical, chemical and microbiological parameters
- electrical safety
- electromagnetic compatibility
- software validation (in connection with hardware and software configurations)
- stability and durability
- drug ingredients
- tissues or cells of human or animal origin as part of the medical device
- pharmacology (absorption, distribution, metabolism, excretion, interactions, tolerability and toxicity)
- sterility parameters
- measurement function parameters
- connection configuration parameters for connected medical devices
This section also documents everything that has to do with the clinical evaluation or investigation.
What Are the Components of a Technical Documentation After it Has Been Placed on the Market?
According to the MDR, a manufacturer must systematically monitor its medical device after it has been placed on the market. The results are part of the technical documentation, which must be updated continuously.
The first part is the post-market surveillance plan. The manufacturer must collect the following information:
- trend reports
- literature data
- feedback and complaints
- information on similar medical devices
The MDR requires the manufacturer to comply with the above “proactively”. The manufacturer must systematically collect information and, if necessary, initiate corrective measures. He must also include a Post-Market Clinical Follow-Up Plan (PMCF) at this point or justify why this is not required.
The second part is the periodic safety update report (PSUR). In simple terms, the safety report is a summary of the following information:
- conclusions from the continuous risk-benefit assessment
- main results of the safety report
- total sales and estimates of frequency of use
Manufacturers of class IIa products update the PSUR as necessary, but at least every 2 years. Manufacturers of class IIb and III products do this at least once a year. Class III and implant manufacturers must also enter the PSUR in the EUDAMED database and thus make it available to the notified body for review.
Manufacturers of class I products do not have to prepare the PSUR and consequently do not have to include it into the technical documentation. However, they are required to prepare a post-market surveillance report, which is updated as necessary and must be submitted to the competent authority on request.
The requirements for technical documentation have increased due to the MDR. It describes in more detail what information a manufacturer must document and emphasizes its continuous updating during the product life cycle.
Nevertheless, the MDR still does not provide an exact structure. However, an uniform structure of the technical documentation has advantages. Manufacturers get a quicker overview of what they must document and can also use simple software efficiently for this purpose. The notified bodies also benefit because they can more easily check the documentation.
One of the best-known and most accepted proposals for a uniform structure of the technical documentation is STED (Summary Technical Documentation) and comes from the International Medical Device Regulators Forum (IMDRF). In any case, it is important that the manufacturers coordinate the structure of the technical documentation with their notified body. This should have a positive effect on the processing time.
It is also important to avoid redundant information and an uncoordinated approach by the departments involved. The technical documentation consists of a large amount of information and is closely linked to the quality management. All relevant expertise should be appropriately involved both communicatively and technically. Finally, the manufacturer must create a document that meets the requirements of the MDR: “clear, organized, readily searchable and unambiguous”.