Poorly structured files or missing information can delay certification, cause regulatory setbacks, or even prevent your device from entering the market. Many manufacturers underestimate how vital the medical device technical file requirements are – right from the early design phase to post-market surveillance.
A well-organized technical file, starting with a detailed device description and specification, is the key to compliance. Mastering the medical device technical file requirements ensures your device is always audit-ready and fully aligned with MDR expectations.
At Billev Pharma East we prepare medical device technical files and ensure they include and meet all the requirements in MDR 2017/745 Annex II. If you need help with preparing a technical file, please visit our website medical devices. Contact us to learn how we can support you throughout the process of preparing your own technical file.
Struggling to keep up with complex documentation demands for your medical device?
The first section of the technical file needs to contain general information about the product:
- product or trade name and a general description of the device,
- unique device identifier (UDI-DI),
- the intended patient population and medical conditions to be diagnosed, treated and/or monitored,
- how the device works,
- why this device can be qualified as a medical device,
- risk class of the device,
- any novel features,
- the accessories for a device (if applicable),
- various configurations of the device,
- key functional elements,
- the used raw materials,
- technical specifications,
- references to any previous generations of the device from the manufacturer (if applicable),
- references to any similar devices already on the market – this is a key element for the notified body to see if there are any critical risks associated with the device. If the device has a well-established use with minimal risks, it can mean that your device gets approved sooner.
At Billev Pharma East, we prepare medical device technical files and ensure they include and meet all the requirements in MDR 2017/745 Annex II. If you need help with preparing a technical file, please visit our website for medical devices. Contact us to learn how we can support you throughout the process of preparing your own technical file.
How do you clearly define the intended purpose and target patient population?
According to MDR Article 2(12), the intended purpose describes how a device is meant to be used, as defined by the manufacturer. This information comes from the label, instructions for use, marketing materials, and the clinical evaluation. The intended use is like the regulatory “DNA” of your device — it determines its classification, drives the clinical evaluation, and shapes post-market surveillance activities.
At Billev Pharma East, we make sure this section meets all regulatory requirements. It must stay consistent across all documents. A clear intended purpose should specify the indications, the clinical setting, the users, and the patient population.
We help ensure that your intended purpose is clear, consistent, and matches your clinical and risk documentation. Our technical file service is here to guide and support you every step of the way. At Billev Pharma East, we provide expert assistance in preparing and maintaining your medical device technical file to ensure compliance and clarity.
How risk management file fits into medical device technical file requirements (MDR)
The Risk Management File (RMF) is a key component of the medical device technical file requirements. It serves as a structured collection of documents demonstrating that all risks associated with device safety have been systematically identified, assessed, controlled, and monitored throughout the device’s entire lifecycle. This includes the risk management plan, risk analysis, risk control measures, and the risk management report—which evaluates the overall risk-benefit ratio. The RMF is developed in alignment with the ISO 14971 standard.
Therefore, a compliant Risk Management File typically includes:
- A risk management plan tailored to the device,
- Identification and analysis of foreseeable hazards and hazardous situations,
- Risk evaluation during intended use and also potential misuse,
- Documentation of risk control measures and residual risk acceptability,
- An assessment of benefit-risk balance, which is updated as necessary,
- Feedback integration from post-market data and production experience.
At Billev Pharma East, we help you structure your data of the initial risk that is assessed through probability and severity of each hazard. We prepare a clear table that compares the initial risk and the residual risk that remains after preventative measures have been taken to address the risks.
Risk management is a continuous iterative process throughout the entire lifecycle of the device and it requires regular updating.
RMF table example backed by ISO 14971 Guidance
Below is a simplified but credible example of how you can structure a risk table within your Risk Management File (RMF), aligning with ISO 14971 principles and terminology:
| Hazard | Hazardous Situation | Initial Risk (Severity × Probability) | Risk Control Measures | Residual Risk | Acceptability / Benefit-Risk Rationale |
|---|---|---|---|---|---|
| Electrical shock | User exposed to live parts during maintenance | High × Medium | Insulation, grounding, protective covers | Low | Acceptable; residual risk low due to robust controls |
| Thermal burn | Device surface overheats during prolonged operation | High × Low | Thermal cutoff, warning labels | Low | Acceptable; benefit of safe operation outweighs residual risk |
| Chemical exposure | Leakage of biocompatibility‑sensitive components | Medium × Medium | ISO 10993 testing, supplier qualification | Low | Acceptable with documentation of supplier compliance |
Which design and manufacturing details must be documented in the technical file?
Design and manufacturing details must be aligned with the medical device technical file requirements and clearly documented within your technical file. The design represents the development process of the device and should be described in a structured and precise manner to ensure full traceability and understanding. At Billev Pharma East, we support you in organizing this information to meet all regulatory expectations and to provide a comprehensive overview of the design stages in line with the medical device technical file requirements.
This part of the Technical file should also contain the complete information and specifications, including the manufacturing processes and their validation, their adjuvants, the continuous monitoring and the final product testing. All of the manufacturing sites should be identified, including all suppliers and sub-contractors. The Technical dossier needs to include the applicable and required certifications and standards of all the included sites where design and manufacturing activities are performed.
One of the common missing pieces of information is usually the outside providers (suppliers and sub-contractors). These are crucial to determine the safety, quality and efficacy of the device, that is why we always make sure to check with our clients whether all of them are included.
What does the GSPR checklist involve under MDR?
The General Safety and Performance Requirements (GSPRs) outlined in MDR Annex I serve as a fundamental part of the medical device technical file requirements. These include 3 chapters and 23 core requirements, which are further divided into specific subclauses. Applicability varies depending on the device’s type and classification. At Billev Pharma East, we prepare structured GSPR checklists to demonstrate compliance and facilitate navigation through the medical device technical file. Each requirement is clearly linked to supporting evidence such as test reports, risk management measures, and clinical data. This ensures a transparent presentation of how your device meets the safety and performance criteria defined in the medical device technical file requirements, making the review process more efficient for assessors.
It is important to keep in mind that not all clauses apply to every device. When preparing the GSPR checklist, that means that some fields do not have data to show. In that case, it is best practice to include a justification as to why the fields are empty. This can greatly reduce questions from assessors and speed up the approval process.
Our method solves this by organizing GSPR tables with links, references, and short explanations for non-applicable clauses. For example, if a GSPR doesn’t apply since it doesn’t have a measuring function or software, we mark this in the table and provide a justification as to why it does not apply. You want to keep this explanation short whenever possible, usually it should be presented in one or two sentences. Writing long explanations could delay your certification since this will prolong the time required for review.
With the above points in mind, our service turns your GSPR checklist into a clear compliance roadmap, not a bureaucratic burden.
Which verification and validation data are essential for technical file compliance?
Verification and validation turn your claims into proof. Verification confirms whether the product was built right (right dimensions, etc.) and validation confirms if the product is working as intended.
This section of the documentation is essential for demonstrating that the device meets the medical device technical file requirements, particularly those related to conformity with the MDR and the applicable General Safety and Performance Requirements (GSPR). The evidence presented includes results and critical analyses supported by a range of verification and validation tests, examinations, and studies. Both clinical and preclinical data are provided, including test designs, study protocols, and data analysis methods. Depending on the device type, the file should cover biocompatibility, physical, chemical and microbiological characterization, electrical safety, electromagnetic compatibility, software verification and validation, as well as stability (including shelf life), performance, and safety. In specific cases, additional information is required, such as when the device incorporates a substance that may be considered a medicinal product, all in line with the comprehensive scope of the medical device technical file requirements.
At Billev Pharma East, we organize verification and validation data to make it traceable and easy to review. This helps avoid delays during conformity checks. We include simulated use, packaging checks, and sterilization validation if needed. Each test has context – why it is done, how it is done, what the results are, and what »pass« means. We also make sure your validation supports your risk controls and device use. Verification and validation isn’t a box to check. It proves that your device works.
What are the key elements of a clinical evaluation report (CER) under MDR?
The Clinical Evaluation Report (CER) is a key element within the medical device technical file requirements, as it demonstrates that your device is both safe and beneficial for patients. In accordance with MDR Article 61 and Annex XIV, the CER must be evidence-based and follow a scientifically sound methodology. Manufacturers are legally required to plan, conduct, and regularly update the clinical evaluation process. This includes defining the intended purpose of the device, identifying target users, outlining expected benefits and potential risks, and establishing methods for outcome measurement. Additionally, the CER must review existing clinical data, identify any evidence gaps, and incorporate both positive and negative findings. The final report should clearly demonstrate compliance with the safety and performance requirements outlined in the medical device technical file requirements.
A quality CER includes a device description, state-of-the-art analysis, clinical data review, benefit-risk conclusion, and an evaluator’s declaration. When preparing a CER we apply strict inclusion criteria, data grading, and statistical support in our evaluations. The quality of data is key. But the quantity needs to be managed as well.
A review of the literature can yield a lot of information. Each reference must be assessed for the strength and relevance of data it provides. So once again, presenting the data in a clear way is key, preferably in a table format. All the references must also be submitted along with the report. One approach that works well is to assign each reference a unique ID that is used throughout the document in all tables, to enable easier assessment by the authorities. Each round of questions that we can avoid speeds up time to approval.
How should you structure the Post-Market Surveillance (PMS) plan within the file?
A good Post-Market Surveillance (PMS) plan shows that you take safety seriously after your device hits the market. Under MDR Article 83, every device needs a PMS plan. It must fit the device’s risk level and how it’s used. The real-use data from devices with CE marking must be collected. This data helps confirm safety, track performance, and catch new risks. It also checks that known risks are still acceptable and that the benefit-risk balance hasn’t changed. The PMCF plan must be written down. It must include how and where you’ll get the data, and why those methods make sense. It should also list what you’re trying to find out—like new side effects, off-label use, or changes in how safe the device is over time.
At Billev Pharma East, we prepare Post-Market Surveillance (PMS) plans that are fully aligned with the medical device technical file requirements and seamlessly integrate into your technical documentation. These plans are directly connected to clinical updates and risk management files, ensuring continuity and traceability. Each PMS plan outlines structured procedures for monitoring complaints, evaluating new scientific literature, analyzing registry data, and conducting user surveys. Every surveillance method is tied to measurable, actionable indicators, enabling you to demonstrate ongoing compliance with safety and performance standards as defined by the medical device technical file requirements.
We make sure the plan works with PSUR and PMCF when needed. A clear, complete plan designed to detect issues early and resolve them quickly. Regulators want proof that you’re not just waiting for problems—they want to see you’re tracking and acting. A strong PMS plan does that.
What MDR-compliant information must be included in labelling and IFU?
Labels and Instructions for Use (IFU) are key to keeping users safe. MDR Annex I, Section 23 lists what must be included—device ID, maker info, purpose, warnings, ISO 15223-1 symbols, and translations.
The label should include:
- The name of the device,
- Details necessary to identify the device,
- Lot number.
- UDI carrier.
- Unambiguous indication of the time limit for using the device or date of manufacturing if there is no indication of the date until when it may be used safely.
- Storage or handling conditions,
- Sterility (if applicable),
- Warnings or precautions,
- Other requirements listed in Annex I, 23.2, depending on the type of device.
Accurate translation of materials such as labelling, instructions for use (IFU), and product claims in marketing content is a critical component of compliance with medical device technical file requirements. This is particularly important for user instructions, where incorrect or unclear translation can compromise both the safety and the claimed performance of the device. At Billev Pharma East, we verify that your labels are consistent with your technical file and that they fulfill all applicable safety requirements. We also ensure that the terminology used in your IFU is aligned with your risk management and clinical documentation, maintaining full conformity with the medical device technical file requirements.
Why the Declaration of Conformity is a critical component of the medical device technical file requirements
The Declaration of Conformity (DoC) is a formal statement confirming that your device complies with all applicable MDR requirements and that the supporting technical documentation meets the medical device technical file requirements. As outlined in MDR Annex IV, the DoC must include specific essential information to demonstrate compliance, such as the manufacturer’s name, address, and Single Registration Number (SRN), if available, as well as details of the authorized representative where applicable. This declaration serves as a critical component of your medical device technical file, ensuring traceability, accountability, and regulatory conformity.
It must clearly state the manufacturer takes full responsibility for the declaration. The DoC must also list the Basic UDI-DI, product name, code, or other traceable identifiers, including the intended purpose. The device’s risk class must be stated, along with a claim of conformity to MDR and any other EU laws that apply. References to Common Specifications (CS), notified body details, issued certificates, and any extra relevant information must also be included. Finally, the DoC needs the place and date of issue, the name and function of the person signing, and their signature on behalf of the company. This document links all parts of the technical file and proves regulatory compliance, making it key for CE marking.
We make sure your DoC is complete, clear, and in the right place. No gaps. No confusion. Just proof your device meets the rules.
Read also:
- Billev Pharma East Achieves ISO 13485:2016 Certification – A Landmark Achievement in Slovenia
- Why is technical file medical device consulting essential for navigating MDR requirements?
- Is your medical device technical file aligned with ISO 14971 risk management requirements?
Source: 1 – Regulation (EU) 2017/745